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U.S. Department of Health and Human Services

Medical Device Exemptions 510(k) and GMP Requirements
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Introduction

Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files.

Class I Devices

FDA has exempted almost all class I devices (with the exception of Reserved Devices from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. Some 510(k) exemptions annotated with "\#\" are with certain limitations as noted in the footnotes. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list the generic category or classification name. Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm

IMPORTANT NOTE: Only the class I devices with an asterisk (*) are also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.

Class II Devices

The Food and Drug Administration (FDA) has also published a list of class II (special controls) devices (those devices are annotated as "(II)"), subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) or the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act. Class II devices are annotated "(II)". Please note that class II devices are NOT exempt from GMP requirements.

PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES Show All Parts
866.2050 staphylococcal typing bacteriophage.  
866.2120 anaerobic chamber.  *
866.2160 coagulase plasma.  
866.2170 automated colony counter.  
866.2180 manual colony counter.  *
866.2300 multipurpose culture medium.  
866.2320 differential culture medium.  
866.2330 enriched culture medium.  
866.2350 microbiological assay culture medium.  
866.2360 selective culture medium.  
866.2440 automated medium dispensing and stacking device.  *
866.2450 supplement for culture media.  
866.2480 quality control kit for culture media.  
866.2500 microtiter diluting and dispensing device.  
866.2540 microbiological incubator.  *
866.2560 microbial growth monitor.  
866.2580 gas-generating device.  
866.2600 wood's fluorescent lamp.  *
866.2660 microorganism differentiation and identification device.  
866.2900 microbiological specimen collection and transport device.  
866.3010 acinetobacter calcoaceticus serological reagents.  
866.3020 adenovirus serological reagents.  
866.3035 arizona spp. serological reagents.  
866.3040 aspergillus spp. serological reagents.  
866.3060 blastomyces dermatitidis serological reagents. (II)  
866.3065 bordetella spp. serological reagents.  
866.3085 brucella spp. serological reagents. (II)  
866.3125 citrobacter spp. serological reagents.  
866.3135 coccidioides immitis serological reagents. (II)  
866.3140 corynebacterium spp. serological reagents.  
866.3145 coxsackievirus serological reagents.  
866.3165 cryptococcus neoformans serological reagents. (II)  
866.3200 echinococcus spp. serological reagents.  
866.3205 echovirus serological reagents.  
866.3220 entamoeba histolytica serological reagents. (II)  
866.3240 equine encephalomyelitis virus serological reagents.  
866.3250 erysipelothrix rhusiopathiae serological reagents.  
866.3255 escherichia coli serological reagents.  
866.3270 flavobacterium spp. serological reagents.  
866.3280 francisella tularensis serological reagents. (II)  
866.3300 haemophilus spp. serological reagents. (II)  
866.3320 histoplasma capsulatum serological reagents. (II)  
866.3330 influenza virus serological reagents.  
866.3340 klebsiella spp. serological reagents.  
866.3350 leptospira spp. serological reagents. (II)  
866.3355 listeria spp. serological reagents.  
866.3360 lymphocytic choriomeningitis virus serological reagents.  
866.3375 mycoplasma spp. serological reagents.  
866.3380 mumps virus serological reagents.  
866.3395 norovirus serological reagents. (II)  
866.3400 parainfluenza virus serological reagents.  
866.3405 poliovirus serological reagents.  
866.3410 proteus spp. (weil-felix) serological reagents.  
866.3415 pseudomonas spp. serological reagents. (II)  
866.3470 reovirus serological reagents.  
866.3480 respiratory syncytial virus serological reagents.  
866.3490 rhinovirus serological reagents.  
866.3500 rickettsia serological reagents.  
866.3520 rubeola (measles) virus serological reagents.  
866.3550 salmonella spp. serological reagents. (II)  
866.3600 schistosoma spp. serological reagents.  
866.3630 serratia spp. serological reagents.  
866.3660 shigella spp. serological reagents. (II)  
866.3680 sporothrix schenckii serological reagents.  
866.3700 staphylococcus aureus serological reagents.  
866.3720 streptococcus spp. exoenzyme reagents.  
866.3740 streptococcus spp. serological reagents.  
866.3850 trichinella spiralis serological reagents.  
866.3930 vibrio cholerae serological reagents. (II)  
866.4100 complement reagent.  
866.4500 immunoelectrophoresis equipment.  
866.4520 immunofluorometer equipment.  
866.4540 immunonephelometer equipment.  
866.4600 ouchterlony agar plate.  
866.4800 radial immunodiffusion plate.  
866.4830 rocket immunoelectrophoresis equipment.  
866.4900 support gel.  
866.5040 albumin immunological test system. (II)  
866.5060 prealbumin immunological test system.  
866.5065 human allotypic marker immunological test system.  
866.5160 beta-globulin immunological test system.  
866.5170 breast milk immunological test system.  
866.5200 carbonic anhydrase b and c immunological test system.  
866.5210 ceruloplasmin immunological test system. (II)  
866.5220 cohn fraction ii immunological test system.  
866.5230 colostrum immunological test system.  
866.5320 properdin factor b immunological test system. (II)  
866.5330 factor xiii, a, s, immunological test system. 3  
866.5360 cohn fraction iv immunological test system.  
866.5370 cohn fraction v immunological test system.  
866.5380 free secretory component immunological test system. (II)  
866.5400 alpha-globulin immunological test system.  
866.5420 alpha-1-glycoproteins immunological test system.  
866.5425 alpha-2-glycoproteins immunological test system.  
866.5430 beta-2-glycoprotein i immunological test system.  
866.5440 beta-2-glycoprotein iii immunological test system.  
866.5460 haptoglobin immunological test system. (II)  
866.5470 hemoglobin immunological test system. (II)  
866.5490 hemopexin immunological test system. (II)  
866.5520 immunoglobulin g (fab fragment specific) immunological test system.  
866.5530 immunoglobulin g (fc fragment specific) immunological test system.  
866.5540 immunoglobulin g (fd fragment specific) immunological test system.  
866.5560 lactic dehydrogenase immunological test system.  
866.5570 lactoferrin immunological test system.  
866.5590 lipoprotein x immunological test system.  
866.5620 alpha-2-macroglobulin immunological test system. (II)  
866.5630 beta-2-microglobulin immunological test system. (II)  
866.5700 whole human plasma or serum immunological test system.  
866.5715 plasminogen immunological test system.  
866.5735 prothrombin immunological test system. 4  
866.5750 radioallergosorbent (rast) immunological test system. (II)  
866.5765 retinol-binding protein immunological test system.  
866.5800 seminal fluid (sperm) immunological test system.  
866.5860 total spinal fluid immunological test system.  
866.5890 inter-alpha trypsin inhibitor immunological test system.  
866.5910 quality control material for cystic fibrosis nucleic acid assays. (II)  
866.5950 genetic health risk assessment system. (II)  



Footnotes:

3 This exemption should not be confused with Sec. 864.7290.
4 This exemption should not be confused with Secs. 864.5425 or 864.7750.
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