Medical Device Exemptions 510(k) and GMP Requirements

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 by submitting Form FDA 2891, "Initial Registration of Device Establishment," and list the generic category or classification name of the device by submitting Form FDA 2892, "Device Listing."

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 864 - HEMATOLOGY AND PATHOLOGY DEVICES

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864.1850	dye and chemical solution stains. ^*
864.1860	immunohistochemistry reagents and kits.
864.2220	synthetic cell and tissue culture media and components.
864.2240	cell and tissue culture supplies and equipment. ^*
864.2260	chromosome culture kit.
864.2280	cultured animal and human cells.
864.2360	mycoplasma detection media and components.
864.2800	animal and human sera.
864.2875	balanced salt solutions or formulations.
864.3010	tissue processing equipment. ^*
864.3250	specimen transport and storage container. ⁸⁶
864.3250	specimen transport and storage container. ⁸⁶ ^*
864.3260	otc test sample collection systems for drugs of abuse testing. ⁸⁷
864.3300	cytocentrifuge.
864.3400	device for sealing microsections.
864.3600	microscopes and accessories. ^*
864.3800	automated slide stainer.
864.3875	automated tissue processor.
864.4010	general purpose reagent. ^*
864.4020	analyte specific reagents.
864.4400	enzyme preparations.
864.5240	automated blood cell diluting apparatus.
864.5350	microsedimentation centrifuge.
864.5800	automated sedimentation rate device.
864.5850	automated slide spinner.
864.6100	bleeding time device. (II)
864.6150	capillary blood collection tube.
864.6160	manual blood cell counting device.
864.6400	hematocrit measuring device. (II)
864.6600	osmotic fragility test.
864.6700	erythrocyte sedimentation rate test.
864.7660	leukocyte alkaline phosphatase test.
864.7675	leukocyte peroxidase test.
864.7900	thromboplastin generation test.
864.8200	blood cell diluent.
864.8500	lymphocyte separation medium.
864.8540	red cell lysing reagent.
864.9125	vacuum-assisted blood collection system. ²
864.9160	blood group substances of nonhuman origin for in vitro diagnostic use. (II)
864.9185	blood grouping view box.
864.9195	blood mixing devices and blood weighing devices. ²
864.9225	cell-freezing apparatus and reagents for in vitro diagnostic use.
864.9275	blood bank centrifuge for in vitro diagnostic use.
864.9320	copper sulfate solution for specific gravity determinations.
864.9550	lectins and protectins. (II)
864.9575	environmental chamber for storage of platelet concentrate. (II)
864.9600	potentiating media for in vitro diagnostic use. (II)
864.9700	blood storage refrigerator and blood storage freezer. (II)
864.9750	heat-sealing device.

Footnotes:

²	Exemption is limited to manual devices.
⁸⁶	This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.
⁸⁷	510(k) exempt only if it is sold, distributed, and used in accordance with the restrictions set forth in 809.40, exempt from GMP only if not labeled or sold as sterile.