FDA Publishes Proposed List of 510(k) Exempt Devices

On March 14, 2017, FDA published a list of about 1,000 devices that would be exempt from 510(k) notification.

Under the Food, Drug, and Cosmetics Act, FD&CA, FDA must classify devices into one of three regulatory classes: Class I, Class II, or Class III. FDA determines the classification by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness.

On December 13, 2016, the President signed the 21st Century Cures Act into law. The law amends the FD&CA and requires FDA to publish, within 90 days of enactment with a 60-day comment period, a Federal Register notice with a list of Class II devices that FDA determines do not require a 510(k) submission. FDA must update the list at least once every 5 years thereafter.

Within 210 days of enactment, FDA must publish a Federal Register notice with the final determination of the 510(k) requirement. For those devices, regulated industry will no longer have to invest time and resources in 510(k) notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.

The Federal Register notice is available from https://www.gpo.gov/fdsys/pkg/FR-2017-03-14/pdf/2017-04938.pdf

The Docket Number is FDA–2017–N–1129. One can make comments to the docket at https://www.regulations.gov.