Glossary › 510(k) › Special 510(k)

GLOSSARYUS

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.

Where it is written: FDA, How To Prepare A Special 510(k) (content current as of 06/28/2024)

Related terms

Traditional 510(k)Abbreviated 510(k)Design Controls

All Terms