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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES > SUBPART A—General (§814.1 to §814.19) > 814.19—Product development protocol (PDP).
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.