510(k)

A premarket submission that shows a device is substantially equivalent to a legally marketed predicate device. It contains the information required by 21 CFR 807.87. The FDA accepts three types: Traditional, Special, and Abbreviated.

Where it is written

21 CFR 807.87; FDA, Premarket Notification 510(k) and How to Prepare a Traditional 510(k) (content current as of 12/14/2023)

Also called

premarket notification, 510k

Types

• Traditional 510(k)Usable under any circumstance to seek marketing authorization through the 510(k) program. Special and Abbreviated 510(k)s are used only when a submission meets certain factors.
• Special 510(k)For a change a manufacturer makes to its own legally marketed device. Verification and validation under design controls can support the substantial equivalence decision for certain changes.
• 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.

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