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Australia Recive el Reconocimiento de Sistema con la U.S. FDA

A partir de Abril 2017 la U.S. Food and Drug Administration (FDA) oficialmente reconoce al Departamento Australiano de Agricultura y Recursos Acuíferos por tener un Sistema de Inocuidad Alimentaria comparable, otorgándole a sus sistemas el reconocimiento. Australia es el tercer país que hace este acuerdo con FDA – siendo el primero Nueva Zelanda en 2012 y siendo el segundo Canadá en 2016.

Este reconocimiento permite las importaciones de alimentos producidos en Australia a los Estados Unidos sin los extensos requerimientos impuestos por el Programa de Verificación de a Proveedores Extranjeros de FSMA. En lugar de conducir análisis de peligros detallados y actividades de verificación como es requerido para los alimentos de otros países, los importadores Estadounidenses ahora pudieran simplemente verificar que la empresa fabricante se encuentra en buen estado con el Departamento de Australia para dicho tipo de producto.

¿Qué es un Reconocimiento de Sistema?

El reconocimiento de sistemas es un acuerdo donde FDA acepta debido a similitud entre su propio Sistema de Inocuidad Alimentaria y aquel de otro país que busca este acuerdo, donde ambos proveen similar protección y monitoreo de productos alimenticios. El concepto está basado sobre la idea de que los Sistemas de Inocuidad Alimentaria apegados a estándares similares producirán similares resultados – idealmente la producción de alimentos seguros.

¿Cuáles son los Beneficios de Ser Reconocido por FDA?

La Ley de Modernización de Inocuidad Alimentaria (FSMA) de la FDA introduce nuevas y extensas regulaciones de inocuidad alimentaria, tanto para instalaciones de alimentos como para importadores Estadounidenses de productos alimenticios. Si bien aún se encuentran sujetas a FSMA, las instalaciones de alimentos en países reconocidos e importadores locales de alimentos fabricados en países reconocidos se benefician de requerimientos modificados. A medida que se concede más confianza a los Sistemas de Inocuidad Alimentaria de países reconocidos, estas partes pudieran ver menos intervención de la FDA como resultado.

Bajo FSMA, las instalaciones de alimentos que fabrican, procesan, empacan o almacenan alimentos para consumo en los EE.UU. necesitan contar con planes de inocuidad alimentaria por escrito, por requerimiento de FDA. Un componente de este plan es un programa de cadena de suministros que ordena a las instalaciones conducir actividades de verificación sobre sus proveedores, como son las auditorías en sitio. En lugar de llevar a cabo estas auditorías ellos mismos, las instalaciones con proveedores en países reconocidos son capaces de verificar a sus proveedores por medio de una inspección conducida por la autoridad en inocuidad alimentaria de dicho país dentro de un año de la fecha requerida de auditoría, siendo un gran ahorro de recursos por gastos de viaje y hospedaje de personal.

FSMA también requiere que los importadores Estadounidenses desarrollen un Plan de Verificación a Proveedores Extranjeros (FSVP), para cada uno de sus proveedores foráneos, que involucre análisis de peligros, verificación de proveedor y acciones correctivas. El reconocimiento de sistemas permite a los importadores renunciar a ciertos aspectos de la regla FSVP, como son el análisis de peligros y la verificación, siempre y cuando ellos continúen monitoreando y encontrando que cada proveedor está cumpliendo con el Sistema de Inocuidad Alimentaria de su país. Como resultado, los importadores son capaces de ahorrar tiempo y esfuerzo así como también gastos por viajes cuando importan alimentos de países reconocidos. Esto pudiera dar ventaja a las instalaciones en países reconocidos sobre sus competidores, como importador Estadounidense pudiera ser más apto importar de instalaciones que requieren menos trabajo bajo FSVP.

Utilice el Asistente FSMA gratuito de Registrar Corp para obtener información sobre como las reglas FSMA afecta a su instalación y país en específico.

¿Cómo se convierte un País en Reconocido?

A manera de lograr un reconocimiento de sistema, un Sistema de Inocuidad Alimentaria gubernamental de un país debe someterse a una revisión de su historial de cumplimiento por FDA. La agencia examinará información sobre rechazos de admisión pasados, alertas de importación de productos originarios de dicho país y otras áreas de importancia. Siguiendo esta revisión, el país interesado realizará una consulta ante FDA para expresar sus objeticos para lograr el reconocimiento de sistemas así como los pasos que necesitan ser tomados para comenzar en este proceso.

Si el país aún está interesado en ser reconocido después de la consulta, su agencia regulatoria o autoridad debe completar el International Comparability Assessment Tool (ICAT) para determinar si su Sistema de Inocuidad alimentaria cumple o no los diez estándares descritos por FDA. Una vez que sea completado, FDA revisará el ICAT junto con la información obtenida durante la revisión inicial. Si declara que el país interesado satisface estos estándares, FDA tomará las medidas necesarias para organizar una evaluación en el país del sistema de inocuidad para intentar finalizar el proceso de reconocimiento del sistema.

¿Puedo continuar exportando a los EE.UU. si mi país no está reconocido?

Mientras que existen beneficios por ser reconocido, el reconocimiento de sistemas es completamente voluntario y no es requerido para exportar alimentos a los Estados Unidos. Una compañía interesada en exportar alimentos a los EE.UU. debe aún completar todos los pasos necesarios para cumplir con las regulaciones FDA.

Si usted representa a una compañía que busca exportar o importar alimentos a los Estados Unidos, Registrar Corp puede ayudarle a cumplir con los requerimientos de la FDA rápida y correctamente. Para obtener mayor información sobre los requerimientos FDA o los servicios de Registrar Corp, por favor llámenos al +1-757-224-0177. Adicionalmente, nuestra asistencia vía chat las 24 horas se encuentra disponible en www.registrarcorp.com/livehelp.

FDA Exenta Ciertos Dispositivos Clase II de la Notificación Previa a la Comercialización (510(k))

El 10 de Julio de 2017, la U.S. Food and Drug Administration (FDA) anunció su exención o exención parcial para ciertos dispositivos clase II de los requerimientos de Notificación Previa a la Comercialización (510(k)). De acuerdo con FDA, los recientes dispositivos exentos “son suficientemente bien conocidos y no presentan un riesgo que requiera la revisión de una notificación previa a la comercialización para proporcionar un aseguramiento razonable de seguridad y efectividad.” Encontrará la lista de los dispositivos afectados más adelante.

¿Qué es un dispositivo parcialmente exento?

Ciertos dispositivos están exentos del 510(k) bajo el Registro Federal solo si cumplen con el criterio especificado por FDA. FDA creó nuevos códigos de productos para dispositivos listados que cumplen este criterio. Los criterios están incluidos en la lista de dispositivos más adelante. La mayoría de exenciones parciales de la FDA son para productos de  uso y aseguramiento de pruebas.

¿Qué significa esto para las compañías de dispositivos médicos?

Las nuevas exenciones pudiera resultar un alivio de carga regulatoria que permite a los fabricantes de los dispositivos afectados avanzar con sus negocios en los Estados Unidos. Los requerimientos 510(k) son comúnmente prohibiciones para fabricantes; las regulaciones son extensas y las pruebas e investigación requeridas pueden ser costosas.

Los fabricantes de dispositivos sujetos a los requerimientos 510(k) deben demostrar a FDA que los dispositivos son “sustancialmente equivalentes” a dispositivos similares legalmente comercializados. Las presentaciones 510(k) deben contener información como es el etiquetado propuesto y advertencias, un resumen de las características tecnológicas del dispositivo, discusión de las pruebas y análisis presentados y muchos otros elementos más. No existe una forma o borrador 510(k), pero toda la información debe tener el formato descrito en 21 CFR 807.

Los fabricantes de dispositivos exentos de 510(k) están aún sujetos a otros requerimientos de la FDA para dispositivos médicos como es el registro anual y el listado, requerimientos UDI, reporte de eventos adversos, requerimientos de etiquetado y cumplimiento de las buenas prácticas de manufactura. Registrar Corp puede asistir a los fabricantes de los recientes productos médicos exentos para cumplir con otras de las regulaciones de la FDA.

Si tiene alguna pregunta o desea asistencia con las regulaciones FDA para dispositivos médicos, contacte con Registrar Corp al +1+757+224-0177 o por chat con un Asesor Regulatorio las 24 horas del día en www.registrarcorp.com/livehelp

Dispositivos Exentos

Sección 21 FCR Tipo de Dispositivo Código de Producto
862.1020 Acid Phosphatase, Nitrophenylphosphate CJN
862.1020 Acid Phosphatase, Thymol Blue Monophosphate CJR
862.1020 Acid Phosphatase, Disodium Phenylphosphate CJX
862.1020 Acid Phosphatase, Naphthyl Phosphate CKB
862.1020 Acid Phosphatase, Thymolphthale Inmonophosphate CKE
862.1020 Acid Phosphatase, Beta Glycerophosphate CKH
862.1020 Acid Phosphatase (Prostatic), Tartrate Inhibited JFH
862.1090 Radioassay, Angiotensin Converting Enzyme KQN
862.1100 Vanillin Pyruvate, AST/SGOT CIF
862.1100 Diazo, AST/SGOT CIQ
862.1100 Hydrazone Colorimetry, AST/SGOT CIS
862.1100 NADH Oxidation/NAD Reduction, AST/SGOT CIT
862.1150 Calibrator, Primary JIS
862.1150 Calibrator, Secondary JIT
862.1150 Calibrator, Surrogate JIW
862.1150 Calibrator, Multi-Analyte Mixture JIX
862.1345 Drink, Glucose Tolerance MRV
862.1350 Continuous Glucose Monitor Secondary Display PJT
862.1445 Chromatographic Separation, Lactate Dehydrogenase Isoenzymes CEX
862.1445 Electrophoretic, Lactate Dehydrogenase Isoenzymes CFE
862.1445 Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes JGF
862.1509 System, Test, Urinary Methylmalonic Acid LPT
862.1685 Radioimmunoassay, Thyroxine-Binding Globulin CEE
862.1700 Radioimmunoassay, Total Thyroxine CDX
862.1700 Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
862.2265 High Throughput DNA Sequence Analyzer PFF
862.2570 Instrumentation For Clinical Multiplex Test Systems NSU
862.2570 Real Time Nucleic Acid Amplification System OOI
862.2570 Mass Spectrometer For Clinical Multiplex Test Systems OTA
862.2570 Micro Total Analysis Instrument System OUE
862.2570 Complete Gene Expression Profiling Accessory Reagents OVA
862.2570 DNA Genetic Analyzer PCA
862.2570 Data Acquisition Software PQQ
862.3200 Calibrators, Drug Mixture DKB
862.3200 Calibrators, Drug Specific DLJ
862.3200 Calibrators, Ethyl Alcohol DNN
864.5400 Fibrometer GIE
864.5400 Timer, Coagulation JBT
864.5425 Control, Plasma, Abnormal GGC
864.5425 Plasma, Coagulation Control GGN
864.5425 Plasma, Control, Normal GIZ
864.6550 Control, Fecal Occult Blood OSL
864.6550 Study, Platelet Adhesive JBZ
864.7275 Test, Euglobulin Lysis JBO
864.7300 Fibrin Monomer Paracoagulation JBN
864.7340 Fibrinogen Standard GFX
864.7340 Plasma, Fibrinogen Control GIL
864.7375 Glutathione, Red-Cell GII
864.7375 Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase JMH
864.7375 Assay, Glutathione Reductase KQF
864.7415 Control, Hemoglobin, Abnormal JCM
864.7455 Stain, Fetal Hemoglobin GHQ
864.7500 Acid Hematin GGF
864.7720 Test, Prothrombin Consumption GGQ
864.7735 Prothrombin-Proconvertin and Thrombotest JPF
864.8150 Calibrator for Cell Indices KRX
864.8165 Calibrator for Hemoglobin and Hematocrit Measurement KRZ
864.8175 Calibrator for Platelet Counting KRY
864.8185 Calibrator for Red-Cell and White-Cell Counting KSA
864.8625 Standards and Controls, Hemoglobin, Normal and Abnormal GFS
864.8625 Control, White-Cell GGL
864.8625 Control, Hemoglobin GGM
864.8625 Control, Platelet GJP
864.8625 Control, Red-Cell GJR
864.8625 Control, Hematocrit GLK
864.8625 Mixture, Control, White-Cell and Red-Cell Indices GLQ
864.8625 Control, Cell Counter, Normal and Abnormal JCN
864.8625 Mixture, Hematology Quality Control JPK
864.8625 Material, Quality Control, Semen Analysis NRF
864.8625 Control Material, Blood Circulating Epithelial Cancer Cell NRS
864.9400 Solution, Stabilized Enzyme KSK
866.3395 Norovirus Serological Reagents OUC
866.5210 Immunochemical, Ceruloplasmin CHN
866.5210 Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control DCT
866.5210 Ceruloplasmin, FITC, Antigen, Antiserum, Control DCY
866.5210 Ceruloplasmin, Antigen, Antiserum, Control DDB
866.5210 P-Phenyl-Enediamine/EDTA (Spectrophotometric), Ceruloplasmin JFQ
866.5210 Indirect Copper Assay, Ceruloplasmin JFR
866.5470 Hemoglobin, Chain Specific, Antigen, Antiserum, Control DAM
866.5620 Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control DDT
866.5620 Alpha-2-Macroglobulin, FITC, Antigen, Antiserum, Control DDY
866.5620 Alpha-2-Macroglobulin, Antigen, Antiserum, Contro DEB
866.5630 System, Test, Beta-2-Microglobulin Immunological JZG
866.5910 Quality Control Material, Genetics, DNA NZB
868.1040 Algesimeter, Powered BSI
868.1400 Legging, Compression, Non-Inflatable LLK
868.2500 Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
868.2500 Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP
868.2550 Pneumotachometer JAX
868.5180 Bed, Rocking, Breathing Assist CCO
868.6250 Compressor, Air, Portable BTI
870.1390 Trocar DRC
870.1875 Lung Sound Monitor OCR
870.2675 Oscillometer DRZ
870.4280 Filter, Prebypass, Cardiopulmonary Bypass KRJ
870.4290 Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
870.4340 Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass DTW
870.4420 Sucker, Cardiotomy Return, Cardiopulmonary Bypass DTS
870.4430 Suction Control, Intracardiac, Cardiopulmonary Bypass DWD
872.1720 Tester, Pulp EAT
872.3260 External Cleaning Solution PME
872.3300 Coating, Denture Hydrophilic, Resin EBE
872.3540 Pad, Denture, Over The Counter EHR
872.3540 Cushion, Denture, Over The Counter EHS
872.3560 Reliner, Denture, Over The Counter EBP
872.3590 Denture, Plastic, Tooth ELM
872.3600 Denture Preformed (Partially Prefabricated Denture) EKO
872.3890 Splint, Endodontic Stabilizing ELS
872.5550 Ring, Teething, Fluid-Filled KKO
872.6770 Syringe, Cartridge EJI
874.1120 Generator, Electronic Noise (for Audiometric Testing) ETS
874.1325 Electroglottograph KLX
874.3310 Calibrator, Hearing Aid/Earphone and Analysis Systems ETW
874.3320 Hearing Aid, Group and Auditory Trainer EPF
874.3320 Device, Assistive Listening LZI
874.3330 Hearing Aid, Master KHL
874.3430 Mold, Middle-Ear ETC
874.3730 Device, Voice Amplification MCK
876.1500 Light Source, Incandescent, Diagnostic FCQ
876.1500 Light Source, Photographic, Fiberoptic FCR
876.1500 Light Source, Fiberoptic, Routine FCW
876.1500 Carrier, Sponge, Endoscopic FGS
876.1500 Light Source, Endoscope, Xenon Arc GCT
876.1500 Transformer, Endoscope GCW
876.1500 LED Light Source NTN
876.1500 Endoscopic Guide Wire, Gastroenterology-Urology OCY
876.4020 Light, Catheter, Fiberoptic, Glass, Ureteral FCS
876.4270 Rod, Colostomy EZP
876.4400 Ligator, Hemorrhoidal FHN
876.4400 Ligator, Esophageal MND
876.4500 Lithotriptor, Biliary Mechanical LQC
876.4770 Urethrotome EZO
876.5010 Bag, Bile Collecting EXF
876.5025 Vibrator for Climax Control of Premature Ejaculation PIA
876.5365 Dilator, Esophageal (Metal Olive) Gastro-Urology EZM
876.5365 Bougie, Esophageal, and Gastrointestinal, Gastro-Urology FAT
876.5365 Dilator, Esophageal KNQ
876.5520 Dilator, Urethral KOE
876.5665 Disinfectant, Subsystem, Water Purification NIH
876.5820 Set, Dialyzer Holder FKI
876.5895 Irrigator, Ostomy EXD
876.5980 Catheter, Retention, Barium Enema With Bag FGD
876.5980 Gastrostomy Tube Holder PLI
878.4370 Drape, Surgical, ENT ERY
878.4370 Drape, Pure Latex Sheet, With Self-Retaining Finger Cot EYX
878.4370 Drape, Urological, Disposable EYY
878.4370 Pad, Kelly FNW
878.4370 Drape, Patient, Ophthalmic HMT
878.4370 Drape, Microscope, Ophthalmic HMW
878.4370 Ring (Wound Protector), Drape Retention, Internal KGW
878.4580 Lamp, Operating-Room FQP
878.4580 Light, Surgical, Instrument FSQ
878.4580 Light, Surgical, Floor Standing FSS
878.4580 Light, Surgical, Endoscopic FSW
878.4580 Light, Surgical, Connector FSX
878.4580 Light, Surgical, Ceiling Mounted FSY
878.4580 Light, Surgical, Carrier FSZ
878.4580 Light, Surgical, Accessories FTA
878.4580 Lamp, Surgical FTD
878.4580 Illuminator, Remote FTG
878.4580 Lamp, Surgical, Incandescent GBC
878.5070 Apparatus, Air Handling, Bench FZG
878.5070 Apparatus, Air Handling, Room FZH
878.5070 Apparatus, Air Handling, Enclosure FZI
880.5580 Locator, Acupuncture Point BWJ
880.5580 Needle, Acupuncture, Single Use MQX
880.5780 Stocking, Medical Support (to Prevent Pooling of Blood in Legs) DWL
882.1020 Analyzer, Rigidity GZM
882.1540 Device, Galvanic Skin Response Measurement GZO
882.1560 Device, Skin Potential Measurement HCJ
882.1855 Encephalogram Telemetry System GYE
882.5895 Vibratory Counter-Stimulation OVP
884.2990 Sheet, Recording, Breast Examination NHM
884.3200 Drain, Cervical HFL
884.4400 Forceps, Obstetrical HDA
884.4530 Clamp, Umbilical HFW
884.4530 Speculum, Vaginal, Nonmetal HIB
884.4530 Speculum, Vaginal, Nonmetal, Fiberoptic HIC
884.4530 Clamp and Cutter, Umbilical NBZ
884.4900 Table, Obstetrical, AC-Powered (and Accessories) HDD
884.4900 Table, Obstetrical, Manual (and Accessories) HHP
884.4900 Table, Obstetric (and Accessories) KNC
884.5200 Hemorrhoid Prevention Pressure Wedge OOA
884.5390 Heater, Perineal, Direct Contact HGZ
884.5390 Heater, Perineal, Radiant, Non-Contact HHA
884.5390 Heater, Perineal KND
884.5400 Cup, Menstrual HHE
884.5425 Pad, Menstrual, Scented HHL
884.6150 Micromanipulators and Microinjectors, Assisted Reproduction MQJ
886.1120 Photorefractor MMF
886.1120 Camera, Ophthalmic, General-Use PJZ
886.1250 Euthyscope, AC-Powered HMK
886.1570 Ophthalmoscope, AC-Powered HLI
886.1570 Ophthalmoscope, Battery-Powered HLJ
886.1570 Ophthalmoscopes, Replacement Batteries, Hand-Held MSG
886.1780 Retinoscope, AC-Powered HKL
886.1945 Transilluminator, AC-Powered HJM
886.4150 Tubing, Replacement, Phacofragmentation Unit MSR
886.4250 Unit, Electrolysis, AC-Powered, Ophthalmic HRO
886.4335 Headlight, Fiberoptic Focusing FCT
886.4335 Light, Headband, Surgical FSR
886.4335 Headlamp, Operating, AC-Powered HPQ
886.4400 Locator, Metal, Electronic HPM
886.4440 Magnet, AC-Powered HPO
886.4790 Sponge, Ophthalmic HOZ
886.4790 Eye Tray OJK
888.1240 Dynamometer, AC-Powered LBB
888.4580 Instrument, Surgical, Sonic and Accessory/Attachment JDX
888.4580 System, Cement Removal Extraction LZV
890.1450 Hammer, Reflex, Powered IKO
890.5100 Bath, Hydro-Massage ILJ
890.5100 Bath, Sitz, Powered ILM
890.5110 Bath, Paraffin IMC
890.5250 Cabinet, Moist Steam IMB
890.5360 Exerciser, Measuring ISD
890.5500 Lamp, Infrared, Therapeutic Heating ILY
890.5575 Device, Warning, Overload, External Limb, Powered IRN
892.1000 MRI Disposable Kit OIM
892.1560 Biopsy Needle Guide Kit OIJ
892.1610 Aperature, Radiographic IZS
892.1610 Cone, Radiographic IZT
892.1610 Collimator, Automatic, Radiographic IZW
892.1610 Collimator, Manual, Radiographic IZX
892.1610 Device, Beam Limiting, X-Ray, Diagnostic KPW
892.1650 Arthrogram Tray OII
892.1650 Radiology Dental Tray OIK
892.1670 Device, Spot-Film IXL
892.1680 Radiographic Contrast Tray OIO
892.1680 Radiology Diagnostic Kit OIP
892.1730 Discography Kit OIL
892.1820 Chair, Pneumocephalographic HBK
892.1850 Cassette, Radiographic Film IXA
892.1860 Changer, Radiographic Film/Cassette KPX
892.1870 Programmer, Changer, Film/Cassette, Radiographic IZP
892.1900 Controller, Temperature, Radiographic EGT
892.1900 Dryer, Film, Radiographic EGW
892.1900 Processor, Radiographic-Film, Automatic, Dental EGY
892.1900 Processor, Radiographic-Film, Automatic IXW
892.1900 Processor, Cine Film IXX
892.2030 Digitizer, Image, Radiological LMA
892.2030 Digitizer, Images, Ophthalmic NFH
892.2040 Camera, Multi Format, Radiological LMC
892.2040 Device, Hardcopy, Images, Ophthalmic NFI
892.5730 Prostate Seeding Kit OIN

Dispositivos Parcialmente Exentos

Sección 21 FCR Tipo de Dispositivo Código de Producto Exento Código de Producto Anterior Limitación de Exención Parcial
862.3100 Enzyme Immunoassay, Amphetamine PUX DKZ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100 Radioimmunoassay, Amphetamine PUX DJP Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100 Thin Layer Chromatography, Amphetamine PUX DIT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100 Gas Chromatography, Amphetamine PUX DOD Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100 Liquid Chromatography, Amphetamine PUX DNI Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100 Free Radical Assay, Amphetamine PUX DJL Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Enzyme Immunoassay, Barbiturate PUY DIS Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Radioimmunoassay, Barbiturate PUY DKN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Thin Layer Chromatography, Barbiturate PUY DKX Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Mercury Dithiazone, Colorimetry, Barbiturate PUY DJN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Hemagglutination Inhibition, Barbiturate PUY DLX Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Gas Liquid Chromatography, Barbiturate PUY DMF Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 High Pressure Liquid Chromatography, Barbiturate PUY KZY Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170 Enzyme Immunoassay, Benzodiazepine PUZ JXM Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170 High Pressure Liquid Chromatography, Benzodiazepine PUZ LAA Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170 Test, Benzodiazepine, Over The Counter PUZ NFV Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170 Gas Chromatography, Benzodiazepine PUZ KZZ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170 Thin Layer Chromatography, Benzodiazepine PUZ LAB Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Enzyme Immunoassay, Cocaine and Cocaine Metabolites PVA DIO Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Radioimmunoassay, Cocaine Metabolite PVA KLN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Enzyme Immunoassay, Cocaine PVA JXO Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Hemagglutination, Cocaine Metabolites (Benzoylecgonine) PVA DLN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Thin Layer Chromatography, Cocaine PVA DMN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Free Radical Assay, Cocaine PVA DIR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Gas Chromatography, Cocaine PVA DIN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Thin Layer Chromatography, Benzoylecgonine PVA DOM Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 High Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites PVA LAC Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3270 High Pressure Liquid Chromatography, Codeine PVB LAE Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3270 Thin Layer Chromatography, Codeine PVB DLD Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3270 Gas Chromatography, Codeine PVB LAD Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3580 Radioimmunoassay, LSD (125-I) PVC DLB Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3580 Free Radical Assay, LSD PVC DOL Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610 Gas Chromatography, Methamphetamine PVD LAF Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610 Thin Layer Chromatography, Methamphetamine PVD DJC Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610 High Pressure Liquid Chromatography, Methamphetamine PVD LAG Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610 Test, Methamphetamine, Over The Counter PVD NGG Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Enzyme Immunoassay, Methadone PVE DJR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Hemagglutination Inhibition, Methadone PVE DIW Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Gas Chromatography, Methadone PVE DMB Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Thin Layer Chromatography, Methadone PVE DKR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Liquid Chromatography, Methadone PVE DNT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Free Radical Assay, Methadone PVE DPP Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3630 Radioimmunoassay, Methaqualone PVF KXS Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Thin Layer Chromatography, Morphine PVG DNK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Radioimmunoassay, Morphine (123-I), Goat Antibody Ammonium Sulfate Sep. PVG DOE Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Fluorometry, Morphine PVG DJJ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Liquid Chromatography, Morphine PVG DPK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Gas Chromatography, Morphine PVG DMY Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Hemagglutination Inhibition, Morphine PVG DLR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Free Radical Assay, Morphine PVG DOK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. PVG DIQ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody PVG DNA Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 Enzyme Immunoassay, Opiates PVH DJG Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 Gas Chromatography, Opiates PVH DJF Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 Hemagglutination, Opiates PVH DLT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 Thin Layer Chromatography, Opiates PVH LAI Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 Free Radical Assay, Opiates PVH DKT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 High Pressure Liquid Chromatography, Opiates PVH LAH Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700 Enzyme Immunoassay, Propoxyphene PVI JXN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700 Thin Layer Chromatography, Propoxyphene PVI DPN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700 Gas Chromatography, Propoxyphene PVI LAJ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700 High Pressure Liquid Chromatography, Propoxyphene PVI LAK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3870 Enzyme Immunoassay, Cannabinoids PVJ LDJ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3870 Reagents, Test, Tetrahydrocannabinol PVJ DKE Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3870 Radioimmunoassay, Cannabinoid(S) PVJ LAT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3910 High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs PVK LFI Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3910 U.V. Spectrometry, Tricyclic Antidepressant Drugs PVK LFH Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3910 Thin Layer Chromatography, Tricyclic Antidepressant Drugs PVK MLK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
866.5750 System, Test, Radioallergosorbent (RAST) Immunological PUW DHB Exemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 3 of this document.
868.2385 Analyzer, Nitrogen Dioxide PUG MRQ Exemption is limited to standalone nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy
870.1330 Wire, Guide, Catheter PTL DQX Exemption is limited to accessory torque devices that are manually operated, nonpatient contacting, and intended to manipulate non-cerebral vascular guide wires.
870.1650 Syringe, Balloon Inflation PTM MAV Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon.
870.2770 Analyzer, Body Composition PUH MNW Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition.
870.4400 Reservoir, Blood, Cardiopulmonary Bypass PTN DTN Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters.
874.1090 Tester, Auditory Impedance PTO ETY Exemption is limited to auditory impedance testers that are in compliance with FDArecognized consensus standard ANSI S3.39.
874.1090 Tympanometer PTP NAS Exemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39.
876.1500 Endoscopic Magnetic Retriever PTQ FCC Exemption is limited to endoscopic magnetic retrievers intended for single use.
876.1500 Scissors For Cystoscope PTR KGD Exemption is limited to sterile scissors for cystoscope intended for single use.
876.1500 Endoscopic Grasping/Cutting Instrument, NonPowered PTS OCZ Exemption is limited to disposable, nonpowered endoscopic grasping/cutting instruments intended for single use.
876.5010 Catheter, Biliary, Surgica PTT GCA Exemption is limited to surgical biliary catheters that do not include a balloon component.
876.5630 Catheter, Peritoneal, Long-Term Indwelling PTU FJS Exemption is limited to non-patient contacting catheter finger grips intended for single use.
876.5630 Catheter, Peritoneal Dialysis, Single Use PTV FKO Exemption is limited to non-patient contacting catheter finger grips intended for single use.
876.5630 System, Peritoneal, Automatic Delivery PTW FKX Exemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales.
878.4370 Drape, Surgical PUI KKX Exemption is limited to surgical drapes that do not include an antimicrobial agent.
878.4495 Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile PTX GAQ Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs
882.1470 Computerized Cognitive Assessment Aid PTY PKQ Exemption is limited to computerized cognitive assessment aids that are not intended for diagnostic assessment of specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand.
884.1630 Colposcope (and Colpomicroscope) PTZ HEX Exemption is limited to standard colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based.
884.4530 Tenaculum, Uterine PUA HDC Exemption is limited to sterile uterine tenaculum devices that do not use suction and are intended for single use.
884.6120 Accessory, Assisted Reproduction PUB MQG Exemption is limited to simple embryo incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/microscope stage warmers; and controlled-rate cryopreservation freezers.
884.6130 Microtools, Assisted Reproduction (Pipettes) PUC MQH Exemption is limited to assisted reproduction microtools (pipettes) manufactured from glass.
884.6160 Labware, Assisted Reproduction PUD MQK Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures.
886.1850 Biomicroscope, SlitLamp, AC-Powered PUE HJO Exemption is limited to slit-lamp, ACpowered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not intended for screening or automated diagnostic indications.
886.3320 Ocular Peg PUF MQU Exemption is limited to ocular pegs supplied sterile.

FDA Extiende la Fecha de Cumplimiento UDI para Dispositivos Clase I hasta 2020

El 2 de Junio de 2017, la U.S. Food and Drug Administration (FDA) emitió una carta anunciando que la agencia intenta extender las fechas de cumplimiento para la Identificación Única de Dispositivos (UDI) para dispositivos clase I y dispositivos no clasificados (excepto dispositivos implantables, de mantenimiento o soporte vital) hasta el 24 de Septiembre de 2020 (dos años después a la fecha de cumplimiento original). FDA planea reafirmar esta extensión con un documento de orientación sobre su aplicación a discreción, sin embargo, la Agencia busca informar a la industria de su decisión a la brevedad posible.

Los Etiquetadores de Dispositivos son responsables de la implementación de los requerimientos UDI de la FDA. De acuerdo con la carta, son varios los etiquetadores que solicitaron a FDA una extensión al darse cuenta de que la cantidad de tiempo necesario que toma el proceso es substancial.  La carta también menciona que “proveer soporte preciso y a tiempo a etiquetadores también ha sido desafiante, debido al gran número y diversidad de dispositivos”, lo cual nos hace creer que varios etiquetadores están teniendo dificultades para completar este proceso por su cuenta.

Con esto en mente, es prudente que los etiquetadores de dispositivos comiencen a prepararse para la fecha de cumplimiento UDI en 2020 tan pronto como sea posible para asegurar que cumplen los requerimientos en tiempo. Los Especialistas Regulatorios de Registrar Corp pueden ayudarle en el proceso UDI, incluyendo la obtención del número DUNS, calculando cuántos UDIs usted necesita, y mucho más. Para obtener asistencia simplemente complete la siguiente forma:

Un mes hasta la fecha límite de cumplimiento del FSVP de la FDA; Herramientas de Cumplimiento por Registrar Corp

Muchos importadores de los EE.UU. están requiriendo cumplir con la regla del Programa de Verificación a Proveedores Extranjeros (FSVP) de la U.S. Food and Drug Administration (FDA) el 30 de Mayo de 2017.

Finalizada en Noviembre 2015 bajo la Ley de Modernización de Inocuidad Alimentaria (FSMA), la regla FSVP de la FDA requiere que los “Importadores FSVP” realicen ciertas actividades para verificar que los alimentos que ellos importan son producidos de manera que cumplen con los estándares de inocuidad de los EE.UU. Si usted no está seguro si es considerado un Importador FSVP, el Asistente FSMA de Registrar Corp puede asistirle sin costo alguno en la determinación de sus requerimientos potenciales.

Evaluando y Aprobando Proveedores

La regla FSVP de la FDA requiere que los Importadores FSVP solo importen de proveedores extranjeros aprobados, a pesar de que ellos pudieran importar de proveedores no aprobados de forma temporal. Para aprobar un proveedor, un Importador FSVP debe considerar el cumplimiento de su proveedor con las regulaciones de inocuidad alimentaria de la FDA, considerando también si el proveedor está sujeto a una Carta de Advertencia de la FDA, alerta de importación u otra acción de cumplimiento FDA relacionada con la inocuidad alimentaria.

Los comentarios sobre la regla final relacionados con este requerimiento reflejan la preocupación de la industria de que el sitio web de la FDA y las bases de datos de cumplimiento pueden ser difíciles de navegar. Para evaluar el cumplimiento de un proveedor usando el sitio web de la FDA, un Importador FSVP tiene que buscar cada base de datos de la FDA aplicable para cada proveedor. El Sistema de Monitoreo de Cumplimiento FDA de Registrar Corp permite a los usuarios evaluar fácilmente los estados de cumplimiento FDA de las instalaciones de alimentos. El Monitor compila información sobre Alertas de Importación FDA, Cartas de Advertencia, Rechazos de Importación y Clasificaciones de Inspección para los proveedores del usuario en un panel de herramientas simple, el cual también permite rastrear si el proveedor está aprobado.

FSVP Basados en el Riesgo

Los Programas de Verificación a Proveedores Extranjeros deben ser creados por un “Individuo Calificado”, definido como un individuo con la educación, entrenamiento o experiencia necesaria para realizar sus actividades asignadas y la habilidad para leer y entender el lenguaje de cualquier registro que deba ser revisado en la realización de una actividad. Un FSVP debe incluir un análisis de peligros y actividades apropiadas de verificación a proveedor para brindar aseguramiento de que estos peligros serán minimizados significativamente o provenidos. Ejemplos de actividades de verificación a proveedor incluyen auditorias, revisión de registros, muestreo y análisis.

¿Qué califica como actividades “apropiadas” de verificación para un proveedor en particular? Esto depende en los tipos de alimentos que son importados y el historial de cumplimiento del proveedor. Los Especialistas en Inocuidad Alimentaria de Registrar Corp actúan como Individuos Calificados y pueden desarrollar o revisar un FSVP para asegurar que son apropiados para sus necesidades específicas.

Acciones Correctivas

Un Importador FSVP debería ser consciente del no cumplimiento de uno de sus proveedores aprobados, el importador debe asegurar que una acción correctiva es tomada. Registrar Corp puede asistir en la implementación de acciones correctivas. Por ejemplo, acción tomada para tener un proveedor extranjero retirado de una alerta de importación pudiera ser considerada una acción correctiva apropiada. Registrar Corp puede ayudar a las instalaciones a crear y presentar una petición a FDA para retirarlo de una alerta de importación. Adicionalmente, errores de etiquetado son una de las mayores causes de cartas de advertencia y detenciones. Registrar Corp puede revisar el etiquetado de alimentos e ingredientes para cumplimiento con FDA.

Para mayor información, asista al seminario en línea gratuito sobre FSVP de Registrar Corp o haga uso de nuestra Ayuda en Vivo En Línea las 24 horas.

Este blog inicialmente se publicó como nota de prensa.

FDA Retira el 28% de Registros de Instalaciones de Alimentos de su Base de Datos en 2017, reporta Registrar Corp

FDA Food Facility Registration Statistics (2017)

Existían 149,933 instalaciones de alimentos registradas con la U.S. Food and Drug Administration (FDA) al 2 de Febrero de 2017. De dichas instalaciones registradas 70,976 (46%) se encontraban fuera de los Estados Unidos. Visualice el número de registros por país aquí.

Los diez países con el mayor número de registros FDA de instalaciones de alimentos se mantienen igual en 2017 a como se reportó en 2016:

Estados Unidos (78957)
Japón (9211)
Francia (7336)
Italia (6169)
China (5236)
México (4499)
Canadá (4169)
España (3208)
República de Corea (2393)
India (1944)

Una investigación reciente reveló que había 207,653 instalaciones de alimentos registradas con FDA al 1 de Junio de 2016 lo que significa que hubo una disminución del 28% en el número de instalaciones registradas desde entonces y hasta Febrero 2017. Esta disminución en instalaciones registradas probablemente se debe a que FDA retiró de su base de datos los registros de instalaciones de alimentos que no fueron propiamente renovadas el 31 de Diciembre de 2016.

Esta disminución en instalaciones registradas es mayor a la caída del 14% que se tuvo después del periodo de renovación de 2014. Esto es probablemente debido a los nuevos requerimientos de verificación implementados durante el periodo de renovación 2016. Las instalaciones de alimentos localizadas fuera de los Estados Unidos son requeridas de designar a un Agente Estadounidense para Comunicaciones con FDA en la renovación de sus registros. A diferencia de años anteriores, individuos o entidades listadas como Agentes Estadounidenses en 2016 fueron requeridos de confirmar con FDA su aprobación de su designación y correspondiente responsabilidad. FDA no consideró confirmada una renovación de instalación 2016 a menos que el Agente Estadounidense designado aceptara por escrito. Si una instalación extranjera presentó su renovación de registro pero su Agente Estadounidense no confirmó afirmativamente, su registro fue retirado de la base de datos de registros de instalaciones de alimentos de la FDA.

La fabricación, procesamiento, empacado o almacenamiento de alimentos para consumo en los EE.UU. so un registro FDA válido es un acto prohibido. Muchas instalaciones no se han dado cuenta de que FDA retiró sus registros hasta que ocurre un problema. Para evitar costosas detenciones o una acción regulatorio, es prudente que todas las instalaciones de alimentos verifiquen que sus registros con FDA fuero propiamente renovados para 2017 antes de continuar con sus negocios de manera normal. Esto es especialmente cierto para instalaciones de alimentos localizadas fuera de los EE.UU. Registrar Corp verificará que su registro de instalación de alimentos FDA fuera renovado propiamente, sin costo alguno. Las instalaciones que necesiten a un Agente Estadounidense pudieran mantener a Registrar Corp. Simplemente contacte con Registrar Corp al +1-757-224-0177 o por chat con un Asesor Regulatorio las 24 horas del día en www.registrarcorp.com/livehelp.

Este blog inicialmente se publicó como nota de prensa.

FDA Retiró de su Base de Datos Establecimientos de Dispositivos Médicos que no hicieron Registro para 2017.

La U.S. Food and Drug Administration (FDA) recientemente retire de su base de datos de registros activos, todos los establecimientos de dispositivos médicos que no hicieron registro para 2017. Dueños u operadores de establecimientos de dispositivos deben registrarse anualmente con FDA. A inicios de Febrero, la Agencia advirtió a la industria que esta retiraría todos los establecimientos que no se habían registrado para 2017 al 23 de Febrero.

Los dispositivos fabricados, preparados, propagados, ensamblados o procesados en un establecimiento no registrado se consideran como “mal etiquetado” y sujetos a una acción regulatoria si son vendidos en los Estados Unidos. Registrar Corp apresura a las compañías de dispositivos médicos a confirmar que sus establecimientos están listados en la base de datos de la FDA como registrados para 2017 antes de continuar con sus negocios como siempre: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

La cuota de registro para el año fiscal 2017 (FY) es de $3,382 USD. Registrar Corp puede ayudar a los establecimientos de dispositivos médicos verificando que sus registros fueron completados para 2017 así como también registrar establecimientos de dispositivos con FDA y facilitar el pago de las cuotas asociadas. Para obtener asistencia, contacte al +1-757-224-0177 o por chat con un Asesor Regulatorio las 24 horas del día en www.registrarcorp.com/livehelp.

Registrar Corp Lanza el Asistente FCE y el Verificador SID para asistir con los Requerimientos FDA para Establecimientos de Alimentos Enlatados

El 14 de Febrero, Registrar Corp, una empresa de consultoría U.S. Food and Drug Administration (FDA), lanzó dos herramientas gratuitas para ayudar a las instalaciones de alimentos en el cumplimiento de los requerimientos FDA para Alimentos Enlatados de Baja Acidez y Alimentos Acidificados.

Muchas de las instalaciones que fabrican, procesa, empacan o almacenan alimentos con intención de ser consumidos en los Estados Unidos requieren registra sus instalaciones de alimentos con la U.S. FDA. Las instalaciones de alimentos que producen ciertos alimentos no perecederos, herméticamente sellados, enlatados de baja acidez o alimentos acidificados deben obtener un Registro de Establecimiento de Alimentos Enlatados (Food Canning Establishment (FCE)). FDA requiere que los fabricantes FCE archiven documentación para cada proceso usado en la producción de alimentos enlatados de baja acidez o alimentos acidificados y asignen únicos “Identificadores de Presentación” (Submission Indentifier (SID)) para cada uno de estos “Archivos de Proceso”. Ejemplos comunes de alimentos sujetos a los requerimientos FCE y SID de la FDA incluyen atún enlatado, pimientos rojos asados enlatados y agua de coco.

El Asistente FCE de Registrar Corp permite a los usuarios identificar si sus productos están sujetos a estas regulaciones FCE y SID de la FDA. El usuario simplemente responde algunas preguntas y el Asistente FCE genera un reporte gratuito indicando los posibles requerimientos para cada producto de la instalación basándose en factores como el pH, la actividad acuosa e ingredientes.

Para individuos conscientes de que sus productos están sujetos a los requerimientos FCE-SID pero que no están seguros de que un SID en particular continúe válido, Registrar Corp ha desarrollado el Verificador SID. El Verificador SID de Registrar Corp permite a los usuarios verificar si algún SID se encuentra archivado en la base de datos de la FDA. Los fabricantes, importadores y agentes aduanales que presentan entradas de alimentos enlatados de baja acidez y alimentos acidificados encontrarán esta herramienta especialmente útil ya que los SIDs válidos debe ser presentados como “Affirmation of Compliance Codes” (AofC) cuando se importan estos productos a los Estados Unidos. Verificar SIDs antes de presentarlos puede ayudar a evitar tiempos largos de detención y errores de entrada que pudieran derivar en evaluaciones de baja prioridad.

El equipo de especialistas FCE de Registrar Corp brinda asistencia con el proceso de registro FCE y ofrece asesoría así como los elementos requeridos, formatos y particularidades para la presentación de SIDs. Para obtener mayor asistencia con los requerimientos FCE y SID de la FDA, contacte con Registrar Corp al +1-757-224-0177 o por chat con un Asesor Regulatorio las 24 horas del día en www.registrarcorp.com/livehelp

Para usar el Asistente FCE, haga clic aquí.

Para usar el Verificador SID, haga clic aquí..

Este blog inicialmente se publicó como nota de prensa.

FDA Retira Establecimientos de Dispositivos Médicos No Registrados de su Base de Datos

El 7 de Febrero, la U.S. Food and Drug Administration (FDA) contactó por correo electrónico a los establecimientos de dispositivos médicos que no completaron su registro anual para 2017. De acuerdo con el correo electrónico, establecimientos que no se registren y paguen la cuota asociada antes del 23 de Febrero de 2017, se eliminarán sus registros de la base de datos de registros activos de la FDA. Los dispositivos médicos fabricados, preparados, propagados, compuestos o procesados en un establecimiento no registrado se consideran como mal etiquetados y están sujetos a una acción regulatoria si se venden en los Estados Unidos.

Registrar Corp Reports: FDA Medical Device Registration Renewals (February 2017)

La cuota de registro para el año fiscal (FY) 2017 es de $3,382 USD. Registrar Corp puede ayudar a los establecimientos de dispositivos médicos a registrarse con FDA y facilitar el pago de las cuotas asociadas. Para obtener asistencia, llámenos al +1-757-224-0177 o por chat con un Asesor Regulatorio las 24 horas del día en www.registrarcorp.com/livehelp.

FDA Remueve Miles de Registros de Instalaciones de Alimentos Expirados de su Base de Datos

El 1 de Febrero de 2017, la U.S. Food and Drug Administration (FDA) removió todos los registros de instalaciones de alimentos que no fueron renovados propiamente para 2017 de su base de datos de registro. Bajo la Ley de Modernización de Inocuidad Alimentaria (FSMA), instalaciones de alimentos requieren renovar su registro FDA entre el 1 de Octubre y el 31 de Diciembre de cada año par. FDA considera todo registro no renovado antes de la fecha límite como expirado y remueve estos registros de su base de datos. Una vez removidos, los números de registro, generalmente, no pueden ser restaurados. Las instalaciones con registros expirados necesitarán re-registrarse con FDA y obtener un nuevo número de registro antes de que ellos fabriquen, procesen, empaque o almacenen alimentos, bebidas o suplementos alimenticios para ser consumidos en los Estados Unidos.

14% de las instalaciones de alimentos registradas con FDA fueron removidas de la base de datos de FDA después del periodo de renovación 2014. El Vicepresidente de Registrar Corp David Lennarz predice que la caída en registros pudiera incluso ser mayor este año debido a los nuevos requerimientos de verificación implementados durante el periodo de renovación 2016. Las instalaciones de alimentos localizadas fuera de los Estados Unidos requieren designar a un Agente Estadounidense para Comunicaciones con FDA en la renovación de sus registros. Diferente a años pasados, individuos o entidades listadas como Agentes Estadounidense en 2016 necesitaron confirmar con FDA su responsabilidad de designación y correspondencia.

Antes de este nuevo paso de verificación, un Agente Estadounidense podría ser designado en una renovación de una instalación extranjera sin el consentimiento por escrito del Agente Estadounidense. Muchas personas previamente designadas como Agentes Estadounidense habrían preferido declinar debido a que un Agente Estadounidense de una instalación extranjera es responsable de obligaciones económicas, incluyendo pagar cuotas para cualquier re-inspección FDA relacionadas con la instalación. El rango de una cuota de re-inspección para establecimientos extranjeros para el Año Fiscal 2017 es de $285 USD por hora (81 FR 50525). FDA pudiera facturar para cualquier aspecto de una re-inspección, incluyendo tiempo invertido en preparación y viaje, por lo que las cuotas pueden irse incrementando rápidamente a miles de dólares. FDA también contacta con los Agentes Estadounidenses para tratar temas sobre cargamentos, programación de inspección y otros asuntos regulatorios. Estos asuntos a menudo requieren una respuesta inmediata.

En 2016, FDA solventó el problema al implementar los nuevos procedimientos de verificación. La agencia no considera la renovación 2016 confirmada de una instalación a menos que el Agente Estadounidense designado acepte positivamente por escrito. Si una instalación extranjera presenta su renovación de registro pero su Agente Estadounidense no acepta positivamente, su registro tendrá que ser removido de la base de datos de registros de instalaciones de alimentos de la FDA.

Para evitar costosas detenciones o acciones regulatorias, es prudente para todas las instalaciones de alimentos verificar que su registro FDA fue propiamente renovado para 2017 antes de continuar sus negocios de manera normal. Esto es especialmente cierto para instalaciones de alimentos localizadas fuera de los EE.UU. Registrar Corp verificará que su registro de instalación de alimentos FDA fue propiamente renovado para 2017 sin consto alguno. Las instalaciones que necesitan a un Agente Estadounidense pudiera nombrar a Registrar Corp. Simplemente contacte con Registrar Corp
+1-757-224-0177  al o por chat con un Asesor Regulatorio las 24 horas del día en www.registrarcorp.com/livehelp

Este blog inicialmente se publicó como nota de prensa.

 

 

FDA Emite Orientación para Presentación de Planes de Advertencia para Cigarros

La U.S. Food and Drug Administration (FDA) recientemente emitió orientación para la industria para asistir con la presentación de planes de advertencia para cigarros. El 10 de Mayo de 2016, FDA publicó una regla final que le otorga a la agencia la autoridad para regular todos los productos de tabaco, incluyendo cigarros, cigarrillos electrónicos, hookah de tabaco y pipas de tabaco.

¿Qué es un plan de advertencia?

Un plan de advertencia detalla como una compañía planea alcanzar distribución aleatoria de las declaraciones de advertencia requeridas en paquetes de cigarro y publicidad. Para cada marca de un producto de cigarros, FDA requiere que todas las declaraciones sean mostradas en el empaque un número igual de veces por un periodo de 12 meses. Todas las declaraciones deben ser distribuidas aleatoriamente en todas las áreas en las que el producto es comercializado en los EE.UU. Para la publicidad, todas las declaraciones de advertencias deben rotarse trimestralmente en una secuencia alterna. Existen seis declaraciones de advertencia requeridas:

  1. ADVERTENCIA: Este producto contiene nicotina. La nicotina es un químico adictivo.
  2. ADVERTENCIA: Fumar cigarro puede causar cáncer de boca y garganta, a pesar de que no lo inhales.
  3. ADVERTENCIA: Fumar cigarro puede causar cáncer de pulmón y enfermedades cardiacas.
  4. ADVERTENCIA: Los cigarros no son una alternativa segura a los cigarrillos.
  5. ADVERTENCIA: El humo del Tabaco incrementa el riesgo de cáncer de pulmón y enfermedades cardiacas, incluso a los no fumadores.
  6. Existen dos opciones para la advertencia de salud reproductiva: 1) ADVERTENCIA: El uso del Cigarro durante el embarazo puede dañar a ti y a tu bebé o 2) ADVERTENCIA GENERAL DEL CIRUJANO: El uso de Tabaco Incremental el Riesgo de Infertilidad, Muerte del Feto o Bajo Peso al Nacer.

¿Quién presenta los planes de advertencia para cigarros?

Un fabricante, distribuidor, importador o vendedor al menudeo de productos de cigarros presenta el plan de advertencia. En muchas de las circunstancias, FDA cree que el fabricante es el más capacitado para crear un plan de advertencia suficiente para el empaque.

¿Cuál es la fecha de cumplimiento límite?

Los planes de advertencia para cigarros deberían ser presentados a FDA el 10 de Mayo de 2017 o 12 meses antes del inicio de la comercialización y publicidad, la fecha que sea posterior. FDA espera que un gran volumen de planes será presentado cerca a esta fecha límite y por lo tanto sugiere que ellos sean presentados a la brevedad posible para asegurar que estos son revisados en tiempo y cumplen con los requerimientos de advertencia que tomarán efecto el 10 de Mayo de 2018. FDA ha considerado esto como ilegal para productos de cigarro que sean producidos, fabricados o distribuidos en los Estados Unidos sin contener en el empaque uno de las declaraciones requeridas una vez que los requerimientos de advertencia tomen efecto.

FDA fomenta a los fabricantes, distribuidores, importadores y vendedores al menudeo de productos de cigarros a presentar sus planes de advertencia en formato electrónico, con todo el contenido en un formato PDF (Portable Document Format). Las presentaciones electrónicas deben ser enviadas por medio del FDA’s Electronic Submissions Gateway.

Registrar Corp es una firma de consultoría U.S. FDA que ayuda a las compañías a cumplir con las regulaciones FDA. Registrar Corp puede ayudar a fabricantes de productos de tabaco a determinar como la orientación de FDA aplica a sus productos en particular. Adicionalmente, Registrar Corp también puede revisar las etiquetas y publicidad de productos de tabaco para asegurar su cumplimiento con las regulaciones de etiquetado FDA. Para mayor información, contacte con Registrar Corp al +1-757-224-0177 o por chat con un Asesor Regulatorio las 24 horas del día en www.registrarcorp.com/livehelp