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Code · CFR · Title 21 — Food and Drugs · Part 814 — Premarket Approval of Medical Devices · § 814.19

§ 814.19. Product development protocol (PDP).

27 words·~1 min read·/us/cfr/t21/s§ 814.19·

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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.
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