GroundRules
21 CFR 814.19: Product development protocol (PDP).
Where this section sits in the code
- 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
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON