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21 CFR 814.19

§ 814.19 Product development protocol (PDP).

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 814.19, § 814.19 Product development protocol (PDP), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88857
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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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.