1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
  6. Subpart A - General
  7. 21 CFR § 814.19
21 CFR § 814.19
Product development protocol (PDP)
June 25, 2020
CFR

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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§ 814.17 Service of orders

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