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 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.

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PART 878 - GENERAL AND PLASTIC SURGERY DEVICES Show All Parts

878.1800	speculum and accessories.
878.3250	external facial fracture fixation appliance.
878.3750	external prosthesis adhesive.
878.3800	external aesthetic restoration prosthesis.
878.3800	external aesthetic restoration prosthesis.  *
878.3900	inflatable extremity splint.
878.3910	noninflatable extremity splint.
878.3910	noninflatable extremity splint.  *
878.3925	plastic surgery kit and accessories.
878.4014	nonresorbable gauze/sponge for external use.
878.4018	hydrophilic wound dressing.
878.4020	occlusive wound dressing.
878.4022	hydrogel wound dressing and burn dressing.
878.4025	silicone sheeting.
878.4040	surgical apparel.
878.4100	organ bag.
878.4160	surgical camera and accessories.
878.4200	introduction/drainage catheter and accessories.
878.4320	removable skin clip.
878.4380	drape adhesive.
878.4440	eye pad.
878.4450	nonabsorbable gauze for internal use.
878.4470	surgeon's gloving cream.
878.4635	ultraviolet lamp for tanning.
878.4660	skin marker.
878.4680	nonpowered, single patient, portable suction apparatus.
878.4700	surgical microscope and accessories.
878.4730	surgical skin degreaser or adhesive tape solvent.
878.4760	removable skin staple.
878.4800	manual surgical instrument for general use.
878.4810	laser surgical instrument for use in general and plastic surgery and in dermatology.
878.4820	surgical instrument motors and accessories/attachments.
878.4930	suture retention device.
878.4950	manual operating table and accessories and manual operating chair and accessories.
878.4960	operating tables and accessories and operating chairs and accessories.
878.5350	needle-type epilator.
878.5360	tweezer-type epilator.
878.5900	nonpneumatic tourniquet.
878.5910	pneumatic tourniquet.

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Footnotes:

7	Exemption is limited to class I category other than surgical gowns and surgical masks.
36	510(k) exempt only if the device is made of the same materials that were used in the device before May 28, 1976.
37	This device is exempt from GMP regulation only if the device is intended for use without an external prosthesis adhesive to fasten it to the body.
38	510(k) exempt only if the device is made of the same materials that were used in the device before May 28, 1976.
39	510(k) exempt only if the device is made of the same materials that were used in the device before May 28, 1976.
40	only the intestinal organ bag is 510(k) exempt.
41	Only special laser gas mixtures used as a lasing medium for this class of lasers are 510(k) exempt.