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.

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