21 CFR 814.19 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Premarket Approval Of Medical Devices (§ 814.1 To § 814.126) — General (§ 814.1 To § 814.19) — Product development protocol (PDP).

4 Aug 2016

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 CFR 814.19