* 510(k) Submissions compare new devices to marketed devices. FDA requests additional information if the relationship between
marketed and “predicate” (pre-Amendments or reclassified post-Amendments) devices is unclear.
** This decision is normally based on descriptive information alone, but limited testing information is sometimes required.
*** Data maybe in the 510(k), other 510(k)s, the Center’s classification files, or the literature.
Read text description of 510(k) "Substantial Equivalence" Decision-Making Process
Updated July 30, 2007
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH