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.
21 CFR Part 814 · Premarket Approval of Medical Devices
§ 814.19 Product development protocol (PDP)
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FDA guidance that cites § 814.19
- Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff 17 Apr 2010
- Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review : Guidance for Industry 19 May 1998
Amendment history
Federal Register documents that created or amended this section.
- 51 FR 26364 22 Jul 1986