21 C.F.R. § 814.19 Product development protocol (PDP).
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
Subpart A—General
§ 814.19 Product development protocol (PDP).
