21 C.F.R. § 814.19

Product development protocol (PDP).

Last amended: 2016Year: 2026Length: 27 wordsOfficial source

Cite as 21 C.F.R. § 814.19 (2026)

A class III device for which a product development protocol has been declared completed by FDA under this chapter will be considered to have an approved PMA.
21 C.F.R. § 814.19: Product development protocol (PDP). | Justis AI