§814.19. Product development protocol (PDP).
21 C.F.R. § 814.19
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.
Source
Source: 51 FR 26364, July 22, 1986, unless otherwise noted.