Abbreviated 510(k)

Relies on FDA guidance documents, special controls, or voluntary consensus standards. The submitter provides summary reports or declarations of conformity. If the FDA finds the submission unsuitable, the FDA converts it to a Traditional 510(k) and keeps the original receipt date.

Where it is written

FDA, How to Prepare an Abbreviated 510(k) (content current as of 06/28/2024)

Related terms