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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2012]
[CITE: 21CFR814.19]
 See Related Information on 814.19 in CDRH databases



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

Sec. 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.
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