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FDA Exempts Certain Class II Devices from Premarket Notification (510(k))

On July 10, 2017, the U.S. Food and Drug Administration (FDA) announced it is exempting or partially exempting certain class II devices from premarket notification (510(k)) requirements. According to FDA, the newly exempt devices “are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.” You’ll find the list of affected devices below.

What is a partially exempt device?

Certain devices are only exempt from 510(k) under the Federal Register if they meet criteria specified by FDA.  FDA created new product codes for listed devices that fit these criteria.  Listed devices that do not meet the criteria will continue to use the pre-existing product code. The criteria are included in the list of partially exempt devices below. The majority of FDA’s partial exemptions are for products intended for employment and insurance testing.

What does this mean for medical device companies?

The new exemptions may prove to be a relief of regulatory burden that allows manufactures of affected devices to move forward with business in the United States.  510(k) requirements are often prohibitive for manufacturers; the regulations are extensive and the testing and research required can be expensive.

Manufacturers of devices subject to 510(k) requirements must prove to FDA that the devices are “substantially equivalent” to similar legally marked devices.   510(k) submissions must contain information such as proposed labeling and advertisements, a summary of the technological characteristics of the device, discussion of submitted tests, and much more.  There is no 510(k) form or template, but all information must be formatted as described in 21 CFR 807.

Manufacturers of 510(k) exempt devices are still subject to other FDA requirements for medical devices, such as annual registration and listing, UDI requirements, adverse event reporting, labeling requirements, and complying with good manufacturing practices.  Registrar Corp can assist manufacturers of newly exempt products to comply with FDA’s other regulations.

For questions or assistance with FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Exempt Devices

21 CFR Section Device Type Product Code
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

Partially Exempt Devices

21 CFR Section Device Type Exempt Product Code Former Product Code (NonExempt) Partial Exemption Limitation
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 Extends UDI Compliance Date for Class I Devices to 2020

On June 2, 2017, the U.S. Food and Drug Administration issued a letter announcing that the Agency intends to extend the Unique Device Identification (UDI) compliance dates for class I and unclassified devices (excluding implantable, life-supporting or life-sustaining devices) to September 24, 2020 (two years after the original compliance date).  FDA plans to solidify this extension with a guidance document regarding its enforcement discretion, but the Agency wanted to inform industry of its decision as early as possible.

Device labelers are responsible for implementing FDA’s UDI requirements.  According to the letter, many labelers asked FDA for an extension upon realizing the substantial amount of time the process takes.  The letter also notes that “providing accurate and timely support to labelers has also been challenging, due to the sheer number and wide diversity of devices,” which leads us to believe many labelers are having difficulty completing the process on their own.

With this in mind, it’s prudent for device labelers to begin preparing for the 2020 UDI compliance date as early as possible to ensure they meet the requirements on time.  Registrar Corp’s Regulatory Specialists can help you navigate the UDI process, including obtaining a DUNS number, calculating how many UDIs you will need, and more.  For assistance, simply complete the form below:

FDA Removed Medical Device Establishments from its Database that Did Not Register for 2017

The U.S. Food and Drug Administration (FDA) recently removed from its database of active registrations all medical device establishments that did not register for 2017.  Owners or operators of device establishments must register annually with FDA.  In early February, the Agency warned industry that it would remove all establishments that had not registered for 2017 by February 23.

Devices manufactured, prepared, propagated, compounded, or processed in an unregistered establishment are misbranded and thus subject to regulatory action if sold in the United States.  Registrar Corp is urging medical device companies to confirm their establishments are listed in FDA’s database as registered for 2017 before continuing business as usual: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

The registration fee for fiscal year (FY) 2017 is $3,382.  Registrar Corp can help medical device establishments verify that their registrations were completed for 2017 as well as register device establishments with FDA and facilitate payment of the associated fees.  For assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

 

FDA to Remove Unregistered Medical Device Establishments from its Database

On February 7, the U.S. Food and Drug Administration (FDA) e-mailed medical device establishments that did not complete their annual registration for 2017.  According to the e-mail, establishments that do not register and pay the associated fees by February 23, 2017 will have their registration removed from FDA’s database of active registrations. Medical devices manufactured, prepared, propagated, compounded, or processed in an unregistered establishment are misbranded and thus subject to regulatory action if sold in the United States.

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

The registration fee for the fiscal year (FY) 2017 is $3,382.  Registrar Corp can help medical device establishments register with FDA and facilitate payment of the associated fees.  For assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

A Year in Review: FDA Drug and Device Regulations in 2016

Registrar Corp keeps industry up-to-date on regulations throughout the year. In 2016, the U.S. Food and Drug Administration (FDA) proposed several new regulations, including label submission requirements for certain devices, and issued extensions for compliance deadlines.

Here’s a compilation of the happenings for the drug and device industries in 2016.

  • February 18: FDA removed 771 drug facilities from the registration database due to failure to complete their annual registration renewal for 2016.
  • August 1: FDA published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).
  • September 8: FDA issued a UDI compliance extension for certain Class II devices.
  • September 24, 2016: This marked the Unique Device Identifier (UDI) compliance date for Class II devices. Read here for tips on UDI compliance.
  • October 20: FDA proposed to require label submissions for Class II and Class III home-use devices.
  • December 21: FDA banned the use of powdered medical gloves due to the substantial risk of illness or injury to both patients and medical professionals.

In addition to the various FDA extensions, proposals, and final rules that were released over the last year, the Federal Trade Commission (FTC) issued new labeling disclaimers for homeopathic drugs.

Registrar Corp is looking forward to the new year and continuing developments in FDA regulation of the drug and device industries. For any questions about FDA drug and device regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

FDA Bans Powdered Medical Gloves

On December 19, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule (21 CFR Parts 878, 880, and 895) banning powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. According to the rule, FDA banned these products due to the fact that they present a substantial risk of illness or injury that cannot be corrected by eliminating or altering product labeling.  Adverse events related to powdered gloves include:

  • Severe airway inflammation
  • Hypersensitivity reactions
  • Allergic reactions
  • Lung inflammation
  • Damage to post-surgical adhesions
  • Respiratory allergic reactions

The final rule becomes effective on January 19, 2017. The ban applies to all powdered gloves currently in commercial distribution, those already sold to consumers, and gloves intended to be distributed in the future. All banned gloves must be removed from the market by the effective date.

FDA defines a medical device ban as “a total prohibition on the current and future sales, distribution, and manufacturing of a medical device.” (21 USC 360f) FDA may analyze a device’s risks and benefits in many ways, including, but not limited to, evaluating medical literature, meeting with experts, or comparing the device to its alternatives. Only one other medical device has been banned by FDA since June 1983.

Registrar Corp is an FDA consulting firm that assists medical device companies with FDA regulations. Registrar Corp can help companies determine whether or not their products are banned under this final rule and review product claims for FDA compliance.  For assistance with FDA regulations for medical gloves or other devices, contact Registrar Corp at +1-757-224-0177 or through our 24-hour Live Help chat service: http://www.registrarcorp.com/livehelp

FDA Reminds Medical Device Companies to Renew Registrations for 2017

The U.S. Food and Drug Administration (FDA) recently sent a reminder to medical device establishments that had not yet registered for 2017.  FDA requires establishments involved in the production or distribution of medical devices intended for use in the United States to register their establishments annually between October 1 and December 31.  The registration fee for the fiscal year (FY) 2017 is $3,382, which is a decrease from the fee for FY 2016 of $3,845.

Registrar Corp Reports: FDA Medical Device Registration Renewal (FY 2017)

A majority of the establishments that must register with FDA must also list their devices and the activities performed on those devices. A list of who is required to register, list, and pay fees can be found here.  It is a prohibited act to manufacture or distribute devices in the United States without a valid FDA registration.  Therefore, it is prudent for any device establishments that plan to continue business in the U.S. in 2017 to renew their registration as soon as possible.

FDA has deemed certain establishments and devices are exempt from registering due to low risk to patients and the role they play in advancing digital health. The product codes of devices that meet the exemption requirements are:

  • LMB – Device, Digital Image Storage, Radiological
  • LMD – System, Digital Image Communications, Radiological
  • NFF – Device, Storage, Images, Ophthalmic
  • NFG – Device, Communications, Images, Ophthalmic
  • OUG – Medical Device Data System
  • NXQ – Daily Assist Devices

Establishments dealing with the devices listed above should not list these devices with FDA during their 2017 registration.

Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations. Registrar Corp can help device establishments determine their applicable FDA registration requirements as well as register establishments and list devices with FDA. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.

FDA Proposes to Require Label Submissions for Class II and Class III Home-Use Devices

On October 14, 2016, the U.S. Food and Drug Administration (FDA) announced a proposed rule that would require device manufacturers to submit labels and package inserts to FDA electronically when listing Class II and Class III home-use devices. The rule would allow manufacturers to submit labels and package inserts for Class I or other excluded home-use devices voluntarily.

FDA defines a home-use device as “a medical device intended for users in any environment outside of a professional healthcare facility.” These devices are intended for use in homes and healthcare facilities where:

  • A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
  • A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.

Some examples of class II home-use devices include powered wheelchairs as well as certain pregnancy test kits. Examples of class III home-use devices include implantable pacemakers and replaceable heart valves.

According to FDA, the proposed rule would “better allow manufacturers to provide such facilities with information that is more robust, up-to-date, and user-friendly.” Once finalized, FDA has plans to make the device labeling information public through an FDA-managed or partner website.  If finalized, manufacturers of class II and class III home-use devices would have to begin submitting labeling information 90 days after the publication of the final rule.

FDA opened this proposed rule for comments on October 17, 2016 for a 90-day period.  Interested parties may submit electronic comments at www.regulations.gov. Enter docket number FDA-2016-N-2491 in the search box.  FDA will review all comments before the release of the final rule, expected January 17, 2017.

Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations for medical devices, including labeling requirements. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.

FDA issues UDI Compliance Extension for Certain Class II Devices

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension to the Unique Device Identification (UDI) compliance deadline for certain class II devices. The original compliance date of September 26, 2016 for the UDI label and submission of data to the Global Unique Identification Database (GUDID) has been extended to September 24, 2018.

The extension to the UDI rule applies to the following class II devices and constituents of certain combination products:

  1. Collections of two or more different devices packaged together in which the devices in the package are not individually labeled
  2. Repackaged single use devices (This extension does not apply to implantable, life-supporting or life sustaining devices.)
  3. Combination products assigned to FDA’s Center for Drug Evaluation and Research (CDER) or FDA’s Center for Biologics Evaluation and Research (CBER) for premarket review

FDA extended the compliance deadline for collections of two or more different devices packaged together to allow the agency time to finalize their draft guidance document titled “Unique Device Identification: Convenience Kits: Draft Guidance for Industry and Food and Drug Administration Staff.”  The deadline for repackaged single use devices is extended only to single use devices that are not individually labeled with an UDI.

Other class II devices are still required to comply with FDA’s UDI rule by September 24, 2016.  Click here for tips for meeting this month’s deadline.

The UDI rule created a system that aims to identify medical devices from their distribution to the supply chain point of use with patients.  Registrar Corp put together a short video on FDA’s UDI requirements.

For assistance with FDA’s UDI requirements or determining your compliance date, contact Registrar Corp at +1-757-224-0177 or talk to a Regulatory Advisor at www.registrarcorp.com/livehelp 24 hours a day.

 

FDA Publishes FY 2017 User Fees for Devices and Generic Drugs

The U.S. Food and Drug Administration (FDA) published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).

Medical Device User Fees for FY 2017

  • Establishment Registration Fee: $3,382 (No Reduction for Small Businesses)
  • Premarket Application (PMA, BLA, PDP): $234,495 / $58,624 for Small Businesses
  • Premarket Notification (510(k)): $4,690 / $ 2,345 for Small Businesses
  • 513(g) request for classification information: $3,166 / $1,583 for Small Businesses
  • PMA Annual Report: $8,207 / $2,052 for Small Businesses

FDA’s FY 2017 medical device user fees show a decrease from FY 2016.

Registrar Corp can register medical device establishments with U.S. FDA as well as review a 510(k) for compliance with submission requirements.

Generic Drug User Fees for FY 2017

Application Fees:

  • Abbreviated New Drug Application (ANDA): $70,480
  • Prior Approval Supplement (PAS) to an ANDA: $35,240
  • Drug Master File (DMF): $51,140

Facility Fees:

  • Active Pharmaceutical Ingredient (API)—Domestic: $44,234
  • API—Foreign: $59,234
  • Finished Dosage Form (FDF)—Domestic: $258,646
  • FDF—Foreign: $273,646

FDA’s FY 2017 ANDA and PAS application fees show a decrease from FY 2016.   The FY 2017 DMF application fee as well as the API and FDF facility fees show an increase from FY 2016.

Registrar Corp can register a drug establishment and file DMFs with U.S. FDA.





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