Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
All TitlesTitle 21Chapter IPart 814Subpart A - Subpart A—General
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
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