1739229668     400-860-0210       语言选择









语言选择




澳大利亚接受美国FDA系统识别

2017年四月, FDA正式认可澳大利亚农业和水资源部的一个类似食品安全系统,给予系统识别认可。继2012年新西兰和2016年加拿大后,澳大利亚成为第三个和FDA达成此合约的国家。

这种识别允许澳大利亚生产的食品在进口到美国的时候可以不用再进行FSMA的外国供应商验证计划的验证。不同于其他国家还需要按要求进行详尽的危害分析和验证活动,美国进口商可以确定,对于澳大利亚部门管理下生产该产品的公司是拥有良好信誉的。

什么是系统识别?

系统识别是指FDA与申请系统识别的国家中都有提供与其类似的食品安全系统和监控系统。这一概念是基于食品安全系统秉承的“类似的标准将产生类似的结果——理论上指食品安全生产”。

FDA识别有何优点?

FDA FSMA对食品企业及美国食品进口商都做了广泛的食品安全的新规定。尽管仍受到FSMA的管制,但对已识别国家的食品企业和进口已识别食品企业的美国进口商都会从修改后的法规内收益良多。由于美国对受识别国家的食品安全系统给予了更多的信心,那么这些企业就会比较少受到FDA的干预。

FSMA法规要求,所有从事生产、加工、包装或贮存的将在美国消费的食品企业都需要提高书面的食品安全计划书。该计划书中有一个部分是供应链计划,要求企业对供应商开展验证活动,如现场审核。与他们自审不同,如果企业的供应商已经在接受FDA识别国家内,那么他们可以通过供应商本国的食品安全局在规定审计的一年内对该企业进行现场检查 。这样可能会省下一些差旅和个人费用。

FSMA同时还要求美国进口商为每个外国供应商创建FSVP,改计划包括危害分析、风险评估,供应商验证及纠正措施。系统识别允许进口商可以忽视FSVP法规的某些具体项目(例如,危害分析和验证计划),只要他们持续对供应商的监控,并符合所在国的食品安全系统。因此,进口商从FDA识别国家进口食品时就可以节省时间、精力和差旅费用。在减少进口商FSVP工作量的情况下,进口商更倾向于和FDA识别国家企业交易,识别国家的企业在可以商业竞争中获得一定优势。

通过Registrar corp 的免FSVP向导来获取信息,查看FSVP的规则是如何影响您的国家和企业的。

一个国家如何被识别? 

为了满足系统识别,国家的政府食品安全系统必须由FDA对其法规历史进行审查。代理需要审核过去拒绝入境的数据,该国家的产品的进口警告,以及其他方面的担忧。审核过后,感兴趣的国家将与FDA进行开会研讨,以概述其实现系统识别的目标以及在这一过程中需要采取的步骤。

如果一个国家在研讨会后仍然对识别感兴趣,他的监管机构或者管理局必须完成ICAT(国际可比性评估工具 )去决定他的食品安全系统是否符合FDA概述的10个标准。然后,FDA将会对使用ICAT收集到的数据进行初步审核。如果认为该感兴趣的国际符合标注,FDA将对其系统在美国境内进行评估,以便最终确定系统识别过程。

我是否可以出口至美国如果我们国家没有被识别?

虽然承认有好处,但系统识别完全是自愿的,不需要向美国出口食品。一家意向出口食品至美国的公司,必须完成符合FDA规定的所有步骤。

如果你代表一家公司想要向美国出口或进口食品,Registrar Corp可以协助您及时并正确的遵循FDA法规要求。获得FDA更多信息或者Registrar Corp的其他服务,您可以拨打+1-757-224-0177。此外,您也可以登录www.registrarcorp.com/livehelp寻求在线帮助。

 

FDA对某些 二类风险等级的器械的豁免了上市前通知(510k)

在2017年的7月10 日, 美国食品药品管理局(FDA)宣布其已对某些二类风险等级器械豁免或者部分豁免上市前通知(510k)的要求。根据食品药品管理局,新豁免的器械“是足够容易理解的,并且不会出现需要通过以提供合理保证其安全有效性的510k审核的风险的器械”。如下请查看豁免和部分豁免的器械清单。

什么是部分豁免器械?

某些器械只有在达到FDA规定的条件下才可以豁免《联邦公告》要求的510k。对已经列名的但可以达到这些条件的器械,FDA创建了新的产品分类代码。而已经列名的但无法达到这种条件的器械,将继续使用先已存在的分类代码。相应的条件已经在如下的清单中包含。其中,部分豁免大多是指用于职业和保险测试的器械。

这对医疗器械企业意味着什么?

新的豁免可能是一种监管负担的减轻,这将容许生产商推进豁免的器械在美国的业务。510k的要求常常对制造商来说过高了;这项法规是全面的,并且其要求的测试和研究费用高昂。

受510k管辖的医疗器械制造商必须向FDA证明其器械“实质等同”于已合法上市的相似器械。510k的提交必须包括诸如标签和宣传、器械技术特性的总结、测试讨论和更多其他的资料。510(k)没有表格或者模板,但是所有的信息必须按照美国联邦法典第21章 第807节中的描述进行格式整理。

510k豁免的器械制造商仍受其他FDA医疗器械要求管辖,例如进行年度的注册和列名、UDI的要求、不良反应报告、标签要求和遵守良好生产规范。Registrar Corp可以协助新豁免产品的制造商符合FDA的其他法规。

如有其他的疑问,或想要FDA医疗器械法规协助,请致电+1-757-224-0177或者通过登录我们的官方网站www.registrarcorp.com/livehelp在线与我们的法规顾问联系。

 豁免器械

21 CFR 章节 器械类型 分类代码
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

部分豁免器械

21 CFR 章节 器械类型 豁免分类代码 原先的分类代码(非豁免的) 部分豁免的限制条件
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将I类医疗器械的UDI合规期限延期至2020年

2017年6月2日,FDA发布通告称一类医疗器械和没有分类的医疗器械(不含植入类、生命维持类或生命延续类设备)的UDI合规日期将延长至2020年9月24日(比原计划晚两年)。 FDA计划通过发布一份关于其自由裁量权的指南文件来落实该计划,但是在指南发布之前想让企业尽早知道该决定。

医疗器械品牌持有人是执行FDA UDI要求的主体。根据该通告,在了解到申请UDI需要大量的时间后许多医疗器械品牌持有人都向FDA提出申请,要求FDA延期。通告称, “巨大的企业数量及繁多的产品种类使得FDA为医疗器械品牌持有人提供准确而及时的支持变得十分艰巨。因此,我们认为需要医疗器械品牌持有人很难自己完成这个任务。”

基于这些原因,医疗器械品牌持有人最好尽早开始为2020年的UDI合规期限做准备。Registrar Corp的专家可以协助贵司了解FDA的UDI申请流程,包括申请邓白氏号码,计算您需要申请多少个UDI,等等。如果您需要我们的帮助,请将下方表格填写完整:

距离FDA外国供应商验证计划截止时间倒计时一个月;Registrar Corp的FDA合规系统

许多美国进口商都必须在2017年5月30日之前遵循美国食品药品管理局(FDA)的外国供应商验证计划(FSVP)的相关要求。

2015年11月 ,美国食品和药品管理局(FDA)颁布了《食品安全现代化法案》配套法规之一的《外国供应商验证计划(FSVP)》最终法案。要求进口商采取相应措施以识别并确保其进口的产品是符合美国的食品安全标准。若您不确定贵司是否为需要遵循FSVP的进口商,Registrar Corp的FSMA向导可以协助贵司来确定相关的要求。

FDA的《外国供应商验证计划(FSVP)》规则要求,受制于FSVP法规的进口商只能从通过批准的外国供应商采购产品,尽管其可能暂时从未经批准的供应商采购。要批准一个供应商,FSVP进口商必须要充分考虑该供应商是否符合FDA的食品安全标准,包括FDA是否曾对其开具任何警告信,是否被FDA列入进口警报名单,或其他与食品安全相关的违规行为。

根据公众对于《外国供应商验证计划(FSVP)》最终法案的评议来看,FDA官方网站以及 数据库都很难搜索到FSVP的相关信息。要想用FDA的官方网站评估一个供应商的合规状况,一个FSVP进口商必须要逐个搜索FDA的所有数据库。Registrar Corp的FDA符合性监控系统让用户可以便捷地评估食品企业在FDA的合规状况。监控系统涵盖了FDA的进口警报、警告信、拒绝入境,以及验厂结果分类数据。用户通过一个界面就可以看到其供应商所有的这些数据。该界面同时也会展示该供应商是否被批准了。

《外国供应商验证计划》必须由具“具备资质的个人”来创建。FDA对于“具备资质的个人”的定义为:受过必要的教育、培训,具有一定的专业经验,能否执行满足法规的各种行为,并且在执行各种行为时能够 理解任何记录文件的个人。一份《外国供应商验证计划》必须包括一份危害分析以及恰当的供应商验证程序以保证这些危害能够最大程度的降低或者预防。供应商验证程序可以包括实地审核,记录文件审核,以及抽样及产品测试。

验证程序的“恰当”程度由美国进口商根据其进口的具体的产品种类以及指定供应商的合规历史来确定。Registrar Corp的食品安全专家作为经过FDA认可的“具备资质的个人”,可以协助企业创建或者审核其《外国供应商验证计划》,以保证其可以满足企业的实际需要。

若FSVP进口商发现某个通过批准的供应商 有不合规的情况出现,其必须立即纠正措施。Registrar Corp可以协助企业制定纠正措施。例如:将外国供应商从FDA的进口警报名单中移除就可以视为一个纠正措施。Registrar Corp可以帮助企业创建并且向FDA递交请求,申请让FDA将其从进口警报名单中移除。此外,贴标错误是导致企业受到警告信和被扣货的最大的根源。Registrar Corp可以审核食品标签及成分以确保其符合FDA的要求。

想了解更多信息,请参加Registrar Corp免费的FSVP网络研讨会,或者使用它们的24小时在线帮助与之联系。

这篇文章最初是作为新闻稿发布的

Registrar Corp报道: 2017年28%的食品企业注册被FDA从系统清除

FDA Food Reg Stats 2017

 

截止2017年2月2日,在美国FDA登记注册的食品企业数量为149933家,与2016年1月1日的207653家相比,整体下降28%。其中海外地区注册企业数为70976家,约占47%。点击此处查阅完整数据。

2017年企业注册数量排名前十的国家相比2016年保持不变:

美国(78957)

日本(9211)

法国(7336)

意大利(6169)

中国(5236)

墨西哥(4499)

加拿大(4169)

西班牙(3208)

韩国(2393)

印度(1,944)

据早前的数据分析,截止2016年1月1日,在FDA注册的食品企业数量为207,653家,这意味着与2017年2月份的数据相比,在FDA注册的食品企业数量整体下降了28%。 分析认为,造成这一结果的原因极有可能是因为美国FDA从数据库中清除掉了所有未能按要求在2016年12月31日进行再注册的企业。

此次的降幅远远超出了在2014年注册更新期限之后的14%。造成这一强烈反差的原因可能是由于FDA系统在2016财年的更新周期实行了新的注册验证流程。 FDA要求非美国企业必须要指定一个美国代理代表其与FDA进行沟通。与往年不同的是,在2016年的更新周期内,被企业指定为美国代理的个人或者企业必须要通过正式书面声明同意担任企业在FDA的美国代理,并且履行美国代理人的相关职责。在美国代理人通过正式书面声明同意担任企业的美国代理之前,企业的更新将被视为未完成。若企业在系统中提交了更新信息,但是其美国代理未完成 书面同意的声明,FDA就会将该企业的注册信息从注册系统中清除。

生产、加工、包装、或者存储供美国的人或者动物消费的食品,但没有有效的FDA注册号码是一种违法行为。在货物被FDA扣留等问题发生之前,很多企业并不知道其注册已经被FDA清除。为了避免扣货导致高昂的经济损失或者法律制裁,对于企业来说在继续出口食品到美国之前先核实其注册是否已经正确更新到2017年不失为一个明智之举,对非美国的企业而言更是尤为重要。Registrar Corp可以免费帮助企业核实其注册是否已经正确更新。需要指定美国代理的企业可以指定Registrar Corp作为其在FDA的美国代理。如有需要,您可以随时致电 +1-757-224-0177或者通过我们的24小时在线帮助与我们的法规顾问联系。

本文首发于PR Newswire

FDA从数据库移除所有未完成更新的医疗器械企业

美国食品药品管理局(FDA)最近将所有未更新到2017年的医疗器械企业从其数据库中移除。医疗器械所有者或经营者每年必须要向FDA更新其注册。在2017年2月初,FDA警告企业,其将会将所有未能在2017年2月23日之前完成更新医疗器械企业从其数据库中移除。

所有从事生产、配制、传播、合成、组装、加工或进出口医疗器械的企业,若其未在FDA进行注册而将产品销售到美国,将会被视为贴标错误,并且FDA将会对其采取强制措施。Registrar Corp在此提醒所有的医疗器械企业在出口前先到FDA的医疗器械企业注册数据库中核实其注册是否已经更新到2017年的状态: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

FDA 2017年(财年)的官方费用为3,382.00美金。Registrar Corp可以协助企业核实其注册是否已经更新到2017年,并且可以为企业进行新的注册。想要获得更多帮助,请随时致电+1-757-224-0177 或者登录www.registrarcorp.com/livehelp ,通过我们官方网站上的“在线帮助”与我们的法规顾问联系!

FDA从数据库移除所有未完成更新的医疗器械企业

2017年2月7日,FDA致函所有未将其注册信息更新到2017年度的医疗器械企业。根据邮件,FDA将会将所有未能在2017年2月23日之前完成更新医疗器械企业从其数据库中移除。所有从事生产、配制、传播、合成、组装、加工或进出口医疗器械的企业,若其未在FDA进行注册而将产品销售到美国,将会被视为贴标错误,并且FDA将会对其采取强制措施。blog pic

FDA 2017年(财年)的官方费用为3,382.00美金。Registrar Corp可以协助企业核实其注册是否已经更新到2017年,并且可以为企业进行新的注册。想要获得更多帮助,请随时致电+1-757-224-0177 或者登录www.registrarcorp.com/livehelp ,通过我们官方网站上的“在线帮助”与我们的法规顾问联系!

FDA从数据库移除多家未完成更新的食品企业

2017年2月1日,美国食品及药物管理局(FDA)注销了所有未能完成2017年注册更新的食品企业。根据食品安全现代化法案(FSMA),食品企业要求在每偶数年的10月1日到12月31日之间更新企业注册。FDA视未能在截止日期之前完成更新的注册为失效注册,并将其从注册数据库移除,移除后的注册号码通常是无法恢复的。注册失效的企业需要向FDA重新注册,在生产、加工、包装和仓储供美销售的食品、饮料和膳食补充食品之前获取新的注册号码。

2014更新期后,14%的注册食品企业被FDA从数据库中移除。Registrar Corp副总裁David Lennarz猜测今年注册企业数量将更大幅度下滑,原因是2016更新期间实施了新的确认法规要求。美国境外的食品企业在注册更新时需要指定一个用于与FDA进行沟通的美国代理。与往年不同,2016更新期间,被指定为美国代理的个人和企业要向FDA确认接受代理委命及其相关职责。

新的确认步骤出台之前,美国代理可以在没有美国代理的正式书面合同的情况下受理完成外国企业的注册更新。为委托企业支付FDA重新验厂费用等经济条件提出后,预计受委托美国代理的数量将会减少。2017财年美国境外工厂重新验厂费率为每小时$285 (81 FR 50525)。FDA重新验厂有多个收费项目,包括花费在材料准备和差旅途中的时间,因此,相应费用很容易就会叠加到数千美金。FDA还会就船运、验厂行程和其他法规事宜联系美国代理,这些都需要美国代理可以迅速回复。

2016年,FDA通过实施新的确认程序解决问题。FDA只有在收到美国代理的正式书面合同的情况下才确认企业完成了2016注册更新。

为避免扣货和其他法规措施,谨慎起见,尤其是食品企业,应在投入运营之前确认完成了2017年度注册的更新。Registrar Corp可免费为贵司确认2017年度注册已通过更新。Registrar Corp可接受美国代理委托。想了解更新信息,欢迎拨打+1-757-224-0177直接和我们美国总部联系或登录www.registrarcorp.com/LiveHelp,我们的法规顾问将24小时在线为您解答疑问。

本文首发用途为新闻发稿

FDA发布雪茄警示计划递交指南

美国FDA最近发布了行业指南,协助企业递交雪茄警示计划。2016年5月,FDA公布最终法规,宣布将所有烟草产品,包括雪茄、电子烟、水烟烟草和管烟纳入管辖范围。

什么是警示计划?

警示计划会详细说明企业计划该达到雪茄包装和广告警示语的随机分配要求。FDA要求雪茄产品各个品牌的所有声明在1年12个月期间的展示相同的次数,随机分配在全美国销售市场。对于广告,所有声明必须交错循环播放。必备警示语有六个:

警告:本产品含有尼古丁,尼古丁为化学添加物

警告:抽雪茄烟会导致口腔和喉咙癌症,即使你不吸入气体。

警告:抽雪茄会导致肺癌和心脏疾病。

警告:雪茄并不是香烟的健康替代选择。

警告:香烟烟雾会提高肺癌和心脏疾病的风险,即使你不是抽烟者。

生殖健康警示有两个选项: 1) 警告:怀孕期间抽雪茄会损害你和胎儿的健康或者 2)外科医生警告:抽香烟会提高不孕、妊娠终止和胎儿发育不良等几率。

雪茄警示计划递交者为?

雪茄厂商、分销商商、进口商和销售商应递交警示计划。大多情况下,FDA认为生产商最有能力建立符合要求的包装警示计划。

合规截止日期为?

雪茄警示计划应在2017年5月10日之前或广告和上市前递交给FDA。FDA希望大部分计划量时提交,因此建议企业尽早提交以确保有足够的计划检视时间,并在生效期2018年5月10日之前符合所有的警示要求。法规生效后,没有以上警示语之一的雪茄产品在美生产、加工和销售,将会被FDA视为违法。

FDA鼓励雪茄厂商、分销商、进口商和零售商通过PDF文档和FDA电子递交通道提交警示计划。

Registrar Corp是一家协助企业遵循FDA法规的咨询机构,我们可以帮助烟草厂商判定FDA法规是否涉及其产品,此外,我们还可以审核烟草产品标签和广告以确保它们符合FDA的标签法规。想了解更多,欢迎拨打+1-757-224-0177直接和我们美国总部联系或登录www.registrarcorp.com/LiveHelp,我们的法规顾问将24小时在线为您解答疑问。

FDA延长烟草申请的合规日期

美国食品及药物管理局最近发布了《烟草申请延期指南》涉及产品为最新纳入烟草范围且于2017年8月8日或之前参与到州际贸易的烟草产品。FDA计划在2017年8月8日之前对非小规模企业和2018年2月8日之前对小规模企业强制执行成分列名递交的法规要求。原执行日期为2017年2月8日。

合规截止日期已延长,以便厂商和进口商能更好地准备申请材料。延期后,某些厂商仍然可以为多种烟草产品递交列名申请。

成分申请应包含以下信息:

  • 厂商/进口商说明
  • 产品说明
  • 成分说明
  • 成分质素

Registrar Corp协助烟草厂商遵循FDA法规,包括注册、列名和标签要求。涉及的烟草厂商如果想要获取更多最近的关于“FDA确立拒绝接受烟草申请法规”的消息,欢迎拨打+1-757-224-0177直接和我们美国总部联系或登录 www.registrarcorp.com/LiveHelp,我们的法规顾问将24小时在线为您解答疑问。