{"data":{"id":"us/21-cfr-814.19","jurisdiction":"us","citation":"21 CFR 814.19","heading":"Product development protocol (PDP).","body":"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.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"ad5c63c3b57dcaa862ec2e5788f3b423b4e84516a902fc3307f0a66e208e23e1","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-814.17","next":"us/21-cfr-814.20"},"notice":"GroundRules: Original legal text. Not legal advice."}