Glossary › 510(k) › Traditional 510(k)

GLOSSARYUS

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.

Where it is written: FDA, How to Prepare a Traditional 510(k) (content current as of 12/14/2023); 21 CFR 807.87

Related terms

Special 510(k)Abbreviated 510(k)

All Terms