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  1. Device Approvals, Denials and Clearances

FDA Continues to Strengthen the 510(k) Program - 2023 Program Update

The 2023 510(k) Program update highlights milestones the FDA has reached since issuing the 510(k) Program report in 2018 and showcases the FDA's ongoing efforts to improve the 510(k) Program.

Webinar on new draft guidances: The FDA will hold a webinar to highlight the efforts to modernize the 510(k) Program and discuss the new 510(k) Program draft guidances listed below:

Browse and Search for 510(k) Clearances

Search the 510(k) Premarket Notification database.

Browse for Clearances by Year

Search the Releasable 510(k) Database

You can also download zipped 510(k) files for specific time periods.

Overview of Section 510(k)

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or indications for use.

General Information

Guidances for Industry and FDA

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