510k Exempt Medical Device Guidance

510k Exempt Medical Device Guidance

New Guidance Expands Class I and II Exemption to Devices Previously “Unclassified” or “Reserved”

New 510 Exempt medical device Guidance was  issued on July 1 by the US Food and Drug Administration. Prior to the 510k exempt medical device Guidance Document a certain group of medical devices were either deemed Class I “reserved devices” or unclassified Class II devices under Section 510(l) of the Food Drug and Cosmetic Act. This meant the unclassified and reserved devices were not directly subject to the Class I and II device exemption provided in the regulations. Under the new Guidance 510k exempt medical device Guidance those devices are now classified not a “reserved” or “unclassified” devices, but as exempt devices.

Recall that exempt devices still require analysis of the exemption criteria before entering the market (see our post here). Class I and II exempt device must assess and record whether the limitations of the exemption are met. If those limitations are met then registration, listing and many cases GMP protocols are required. If those limitations are not met, however, the exemption does not apply and a pre-market application of some type (510(k), 513(g), de novo, PMA) is required prior to registration, listing and GMP protocols. The new 510k exempt medical device guidance does not change this bedrock principle of device exemption. The Guidance simply makes the exemption available to a new expanded group of devices.

Those devices exempted under the new 510k exempt medical device guidance are available at the link here.

Contact our Washington D.C. or Charlotte office with any questions about Class I and II exemption criteria and pre-market requirements.


Share this:
Posted in , and tagged with
Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

Leave a Comment

You must be logged in to post a comment.

Are you in trouble with the FDA?

Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation right now.

Expert knowledge of FDA regulations that helps you strategically grow your business