1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 814
  5. subpart A
  6. § 814.19

View all text of Subpart A [§ 814.1 - § 814.19]

§ 814.19 - Product development protocol (PDP).

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.

AUTHORITY: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

SOURCE: 51 FR 26364, July 22, 1986, unless otherwise noted.

CITE AS: 21 CFR 814.19