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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 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Show All Parts
862.1020 acid phosphatase (total or prostatic) test system. (II)  
862.1030 alanine amino transferase (alt/sgpt) test system.  
862.1040 aldolase test system.  
862.1060 delta-aminolevulinic acid test system.  
862.1075 androstenedione test system.  
862.1080 androsterone test system.  
862.1090 angiotensin converting enzyme (a.c.e.) test system. (II)  
862.1095 ascorbic acid test system.  
862.1100 aspartate amino transferase (ast/sgot) test system. (II)  
862.1115 urinary bilirubin and its conjugates (nonquantitative) test system.  
862.1130 blood volume test system.  
862.1135 c-peptides of proinsulin test system.  
862.1150 calibrator. (II)  
862.1165 catecholamines (total) test system.  
862.1175 cholesterol (total) test system.  
862.1180 chymotrypsin test system.  
862.1185 compound s (11-deoxycortisol) test system.  
862.1190 copper test system.  
862.1195 corticoids test system.  
862.1200 corticosterone test system.  
862.1210 creatine test system.  
862.1240 cystine test system.  
862.1245 dehydroepiandrosterone (free and sulfate) test system.  
862.1250 desoxycorticosterone test system.  
862.1255 2,3-diphosphoglyceric acid test system.  
862.1260 estradiol test system.  
862.1265 estriol test system.  
862.1270 estrogens (total, in pregnancy) test system.  
862.1275 estrogens (total, nonpregnancy) test system.  
862.1280 estrone test system.  
862.1285 etiocholanolone test system.  
862.1290 fatty acids test system.  
862.1300 follicle-stimulating hormone test system.  
862.1305 formiminoglutamic acid (figlu) test system.  
862.1320 gastric acidity test system.  
862.1325 gastrin test system.  
862.1330 globulin test system.  
862.1335 glucagon test system.  
862.1345 glucose test system. (II)  
862.1350 continuous glucose monitor secondary alarm system. (II)  
862.1360 gamma-glutamyl transpeptidase and isoenzymes test system.  
862.1365 glutathione test system.  
862.1370 human growth hormone test system.  
862.1375 histidine test system.  
862.1380 hydroxybutyric dehydrogenase test system.  
862.1385 17-hydroxycorticosteroids (17-ketogenic steroids) test system.  
862.1390 5-hydroxyindole acetic acid/serotonin test system.  
862.1395 17-hydroxyprogesterone test system.  
862.1400 hydroxyproline test system.  
862.1405 immunoreactive insulin test system.  
862.1410 iron (non-heme) test system.  
862.1415 iron-binding capacity test system.  
862.1420 isocitric dehydrogenase test system.  
862.1430 17-ketosteroids test system.  
862.1435 ketones (nonquantitative) test system.  
862.1440 lactate dehydrogenase test system. (II)  
862.1445 lactate dehydrogenase isoenzymes test system. (II)  
862.1450 lactic acid test system.  
862.1460 leucine aminopeptidase test system.  
862.1465 lipase test system.  
862.1470 lipid (total) test system.  
862.1475 lipoprotein test system.  
862.1485 luteinizing hormone test system.  
862.1490 lysozyme (muramidase) test system.  
862.1500 malic dehydrogenase test system.  
862.1505 mucopolysaccharides (nonquantitative) test system.  
862.1509 methylmalonic acid (nonquantitative) test system. (II)  
862.1510 nitrite (nonquantitative) test system.  
862.1515 nitrogen (amino-nitrogen) test system.  
862.1520 5'-nucleotidase test system.  
862.1530 plasma oncometry test system.  
862.1535 ornithine carbamyl transferase test system.  
862.1540 osmolality test system.  
862.1542 oxalate test system.  
862.1550 urinary ph (nonquantitative) test system.  
862.1560 urinary phenylketones (nonquantitative) test system.  
862.1565 6-phosphogluconate dehydrogenase test system.  
862.1570 phosphohexose isomerase test system.  
862.1575 phospholipid test system.  
862.1580 phosphorus (inorganic) test system.  
862.1590 porphobilinogen test system.  
862.1595 porphyrins test system.  
862.1605 pregnanediol test system.  
862.1610 pregnanetriol test system.  
862.1615 pregnenolone test system.  
862.1620 progesterone test system.  
862.1625 prolactin (lactogen) test system.  
862.1630 protein (fractionation) test system.  
862.1635 total protein test system. (II)  
862.1640 protein-bound iodine test system.  
862.1645 urinary protein or albumin (nonquantitative) test system.  
862.1650 pyruvate kinase test system.  
862.1655 pyruvic acid test system.  
862.1660 quality control material (assayed and unassayed). 1  
862.1670 sorbitol dehydrogenase test system.  
862.1685 thyroxine-binding globulin test system. (II)  
862.1700 total thyroxine test system. (II)  
862.1705 triglyceride test system.  
862.1710 total triiodothyronine test system. (II)  
862.1715 triiodothyronine uptake test system. (II)  
862.1720 triose phosphate isomerase test system.  
862.1725 trypsin test system.  
862.1775 uric acid test system.  
862.1780 urinary calculi (stones) test system.  
862.1785 urinary urobilinogen (nonquantitative) test system.  
862.1790 uroporphyrin test system.  
862.1795 vanilmandelic acid test system.  
862.1805 vitamin a test system.  
862.1815 vitamin e test system.  
862.1820 xylose test system.  
862.1840 total 25-hydroxyvitamin d mass spectrometry test system. (II)  
862.2050 general purpose laboratory equipment labeled or promoted for a specific medical use.  
862.2050 general purpose laboratory equipment labeled or promoted for a specific medical use.  *
862.2100 calculator/data processing module for clinical use.  
862.2120 continuous glucose monitor data management system.  
862.2140 centrifugal chemistry analyzer for clinical use.  
862.2150 continuous flow sequential multiple chemistry analyzer for clinical use.  
862.2160 discrete photometric chemistry analyzer for clinical use.  
862.2170 micro chemistry analyzer for clinical use.  
862.2230 chromatographic separation material for clinical use.  
862.2250 gas liquid chromatography system for clinical use.  
862.2260 high pressure liquid chromatography system for clinical use.  
862.2265 high throughput genomic sequence analyzer for clinical use. (II)  
862.2270 thin-layer chromatography system for clinical use. 79  
862.2270 thin-layer chromatography system for clinical use. 79  *
862.2300 colorimeter, photometer, or spectrophotometer for clinical use.  
862.2310 clinical sample concentrator.  
862.2320 beta or gamma counter for clinical use.  
862.2400 densitometer/scanner (integrating, reflectance, tlc, or radiochromatogram) for clinical use.  
862.2485 electrophoresis apparatus for clinical use.  
862.2500 enzyme analyzer for clinical use.  
862.2540 flame emission photometer for clinical use.  
862.2560 fluorometer for clinical use.  
862.2570 instrumentation for clinical multiplex test systems. (II)  
862.2680 microtitrator for clinical use.  
862.2700 nephelometer for clinical use.  
862.2720 plasma oncometer for clinical use.  
862.2730 osmometer for clinical use.  
862.2750 pipetting and diluting system for clinical use.  
862.2800 refractometer for clinical use.  
862.2850 atomic absorption spectrophotometer for clinical use.  
862.2860 mass spectrometer for clinical use.  
862.2900 automated urinalysis system.  
862.2920 plasma viscometer for clinical use.  
862.3050 breath-alcohol test system.  
862.3100 amphetamine test system. (II)  
862.3150 barbiturate test system. (II)  
862.3170 benzodiazepine test system. (II)  
862.3200 clinical toxicology calibrator. (II)  
862.3220 carbon monoxide test system.  
862.3240 cholinesterase test system.  
862.3250 cocaine and cocaine metabolite test system. (II)  
862.3270 codeine test system. (II)  
862.3280 clinical toxicology control material. 1  
862.3610 methamphetamine test system. (II)  
862.3620 methadone test system. (II)  
862.3630 methaqualone test system. (II)  
862.3640 morphine test system. (II)  
862.3650 opiate test system. (II)  
862.3700 propoxyphene test system. (II)  
862.3800 reagents for molecular diagnostic instrument test systems.  
862.3870 cannabinoid test system. (II)  
862.3910 tricyclic antidepressant drugs test system. (II)  



Footnotes:

1 Exemption is limited to unassayed material, except when used in conjunction with donor screening tests.
79 Some components are exempt from GMP.
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