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§ 814.19 Product development protocol (PDP).

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Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES > PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES > Subpart A—General

This text was captured on Sep 22, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

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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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