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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: http://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 now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization 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 a requirement of the Modernization Act. Class II devices are annotated "(II)". Please note that class II devices are NOT exempt from GMP requirements.


PART 886 - OPHTHALMIC DEVICES Show All Parts
886.1040 ocular esthesiometer.  
886.1050 adaptometer (biophotometer).  
886.1070 anomaloscope.  
886.1090 haidinger brush.  
886.1140 ophthalmic chair. 55  
886.1140 ophthalmic chair. 55  *
886.1150 visual acuity chart.  *
886.1160 color vision plate illuminator.  
886.1170 color vision tester.  *
886.1190 distometer.  *
886.1200 optokinetic drum.  *
886.1250 euthyscope. 56  
886.1270 exophthalmometer.  
886.1290 fixation device.  
886.1320 fornixscope.  *
886.1330 amsler grid.  *
886.1340 haploscope.  
886.1350 keratoscope. 57  
886.1350 keratoscope. 57  *
886.1375 bagolini lens.  *
886.1380 diagnostic condensing lens.  *
886.1390 flexible diagnostic fresnel lens.  *
886.1395 diagnostic hruby fundus lens.  *
886.1400 maddox lens.  *
886.1405 ophthalmic trial lens set.  
886.1410 ophthalmic trial lens clip.  
886.1415 ophthalmic trial lens frame.  *
886.1420 ophthalmic lens gauge.  
886.1425 lens measuring instrument.  
886.1430 ophthalmic contact lens radius measuring device.  
886.1435 maxwell spot.  
886.1450 corneal radius measuring device. 58  
886.1460 stereopsis measuring instrument.  *
886.1500 headband mirror.  
886.1605 perimeter. 59  
886.1605 perimeter. 59  *
886.1650 ophthalmic bar prism.  *
886.1655 ophthalmic fresnel prism.  *
886.1660 gonioscopic prism.  
886.1665 ophthalmic rotary prism.  *
886.1680 ophthalmic projector.  
886.1690 pupillograph.  
886.1700 pupillometer. 60  
886.1700 pupillometer. 60  *
886.1750 skiascopic rack.  
886.1760 ophthalmic refractometer.  
886.1770 manual refractor.  *
886.1780 retinoscope. 13  *
886.1790 nearpoint ruler.  *
886.1800 schirmer strip. 61  
886.1810 tangent screen (campimeter). 62  
886.1810 tangent screen (campimeter). 62  *
886.1840 simulatan (including crossed cylinder).  *
886.1860 ophthalmic instrument stand. 63  
886.1860 ophthalmic instrument stand. 63  *
886.1870 stereoscope. 64  
886.1870 stereoscope. 64  *
886.1880 fusion and stereoscopic target.  *
886.1905 nystagmus tape.  *
886.1910 spectacle dissociation test system. 65  
886.1910 spectacle dissociation test system. 65  *
886.1940 tonometer sterilizer.  
886.1945 transilluminator. 76  
886.3100 ophthalmic tantalum clip. (II)  
886.3130 ophthalmic conformer. (II)  
886.3200 artificial eye. 66  
886.3800 scleral shell. (II)  
886.4070 powered corneal burr. 14  
886.4230 ophthalmic knife test drum.  *
886.4250 ophthalmic electrolysis unit. 77  
886.4300 intraocular lens guide. 15  
886.4335 operating headlamp. 78  
886.4350 manual ophthalmic surgical instrument.  
886.4360 ocular surgery irrigation device.  
886.4445 permanent magnet.  *
886.4570 ophthalmic surgical marker.  
886.4750 ophthalmic eye shield.  *
886.4770 ophthalmic operating spectacles (loupes).  *
886.4855 ophthalmic instrument table. 67  
886.4855 ophthalmic instrument table. 67  *
886.5120 low-power binocular loupe.  *
886.5420 contact lens inserter/remover.  
886.5540 low-vision magnifier.  *
886.5600 ptosis crutch.  *
886.5800 ophthalmic bar reader.  *
886.5810 ophthalmic prism reader.  *
886.5820 closed-circuit television reading system. 68  
886.5840 magnifying spectacles.  
886.5842 spectacle frame.  
886.5844 prescription spectacle lens.  
886.5850 sunglasses (nonprescription).  
886.5870 low-vision telescope.  *
886.5900 electronic vision aid.  
886.5910 image intensification vision aid.  *
886.5915 optical vision aid. 69  
886.5915 optical vision aid. 69  *




Footnotes:

13 Exemption is limited to class I battery-powered devices.
14 Exemption is limited to rust ring removal.
15 Exemption does not apply if used as folders and injectors for soft or foldable IOL's.
55 The AC-powered device and manual devices are 510(k) exempt. The manual device is also exempt from GMP regulation.
56 Only battery-powered is 510(k) exempt.
57 The battery powered device is 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.
58 510(k) exempt only when the device doesn't include computer software in the unit or topographers.
59 Only manual device is 510(k) and GMP exempt.
60 The AC-powered device and manual devices are 510(k) exempt. The manual device is also exempt from GMP regulation.
61 510(k) exempt only if the device is made of the same materials that were used in the device before May 28, 1976.
62 The AC-powered and battery-powered devices are 510(k) exempt. The battery-powered device is also exempt from GMP.
63 The AC-powered and battery-powered devices are 510(k) exempt. The battery-powered device is also exempt from GMP.
64 The AC-powered and battery-powered devices are 510(k) exempt. The battery-powered device is also exempt from GMP.
65 The AC-powered and battery-powered devices are 510(k) exempt. The battery-powered device is also exempt from GMP.
66 New Definition: An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted. 510(k) exempt only if the device is made from the same materials, has the same chemical composition, and uses the same manufacturing processes as currently legally marketed devices.
67 The AC-powered device and manual devices are 510(k) exempt. The manual device is also exempt from GMP regulation.
68 Only AC-powered device.
69 The AC-powered and battery-powered devices are 510(k) exempt. The battery-powered device is also exempt from GMP.
76 Only battery-powered is 510(k) exempt.
77 Only battery-powered is 510(k) exempt.
78 Only battery-powered is 510(k) exempt.
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