Medical Device Exemptions 510

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 record keeping 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 878 - GENERAL AND PLASTIC SURGERY DEVICES

Grade 420 stainless steel," "Inspected via ASTM F899 standards").
878.1800	speculum and accessories.
878.3250	external facial fracture fixation appliance. ³⁶
878.3750	external prosthesis adhesive.
878.3800	external aesthetic restoration prosthesis. ³⁷
878.3800	external aesthetic restoration prosthesis. ³⁷ ^*
878.3900	inflatable extremity splint.
878.3910	noninflatable extremity splint. ³⁸
878.3910	noninflatable extremity splint. ³⁸ ^*
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. (II) ⁷
878.4040	surgical apparel. ⁷
878.4100	organ bag. ⁴⁰
878.4160	surgical camera and accessories.
878.4165	wound autofluorescence imaging device.
878.4200	introduction/drainage catheter and accessories.
878.4320	removable skin clip.
878.4370	surgical drape and drape accessories. (II)
878.4380	drape adhesive.
878.4440	eye pad.
878.4450	nonabsorbable gauze for internal use.
878.4470	surgeon's gloving cream.
878.4495	stainless steel suture. (II)
878.4580	surgical lamp. (II)
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.
878.4740	surgical stapler.
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. ⁴¹
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.
878.5070	air-handling apparatus for a surgical operating room. (II)
878.5080	air-handling apparatus accessory.
878.5350	needle-type epilator.
878.5360	tweezer-type epilator.
878.5900	nonpneumatic tourniquet.
878.5910	pneumatic tourniquet.

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.

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PART 610	GENERAL BIOLOGICAL PRODUCTS STANDARDS
PART 660	ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
PART 862	CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
PART 864	HEMATOLOGY AND PATHOLOGY DEVICES
PART 866	IMMUNOLOGY AND MICROBIOLOGY DEVICES
PART 868	ANESTHESIOLOGY DEVICES
PART 870	CARDIOVASCULAR DEVICES
PART 872	DENTAL DEVICES
PART 874	EAR, NOSE, AND THROAT DEVICES
PART 876	GASTROENTEROLOGY-UROLOGY DEVICES
PART 878	GENERAL AND PLASTIC SURGERY DEVICES
PART 880	GENERAL HOSPITAL AND PERSONAL USE DEVICES
PART 882	NEUROLOGICAL DEVICES
PART 884	OBSTETRICAL AND GYNECOLOGICAL DEVICES
PART 886	OPHTHALMIC DEVICES
PART 888	ORTHOPEDIC DEVICES
PART 890	PHYSICAL MEDICINE DEVICES
PART 892	RADIOLOGY DEVICES

In the United States, Manual Surgical Instruments are medical devices used by clinicians to perform physical actions during surgery (such as cutting, grasping, retracting, or clamping) without being attached to an active power source. The FDA regulates these tools under 21 CFR Part 878 (General Surgery and Plastic Surgery Devices) or 21 CFR Part 888 (Orthopedic Devices), depending on their clinical specialty.

Regulatory Classification & Exemption

The vast majority of manual surgical instruments fall under a low-risk category, which simplifies their path to market:

Class I (General Controls): Includes everyday tools like manual bone rongeurs, chisels, osteotomes, scalpel handles, surgical scissors, tissue forceps, and retractors.
510(k) Premarket Notification Exemption:
Most of these Class I instruments are explicitly exempt from premarket notification submission requirements.

When a medical device is classified by the FDA as exempt from premarket notification submission requirements, it means that a manufacturer does not need to submit a 510(k) application or wait for FDA clearance before commercially distributing the product in the United States.

The FDA grants this exemption to devices that are well-understood, have a proven track record, and present low enough risks that a formal premarket file review is unnecessary to ensure safety and effectiveness.

Which Devices Qualify for Exemption?

Exemptions are primarily organized by device risk and historic regulatory frameworks:

Most Class I Devices: The vast majority of low-risk devices (such as elastic bandages, manual surgical scalpels, and tongue depressors) are automatically exempt.

In the United States, manual surgical scalpels are regulated by the FDA under 21 CFR § 878.4800 as "manual surgical instruments for general use". This classification applies to individual scalpel components as well as unified assemblies:

Scalpel Blades are assigned the FDA product code GES.
Scalpel Handles are assigned the FDA product code GDZ.

1. Classification and 510(k) Status

Class I Device: Scalpels are officially designated as low-risk Class I medical devices.
510(k) Exemption: They are exempt from premarket notification submission requirements. You do not need formal FDA clearance or approval before launching the product into commercial distribution.