510(k) “Substantial Equivalence” Decision Making Process
* 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.