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title 21
Food and Drugs
chapter I-i7
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
part 814
PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
subpart C
Subpart C—FDA Action on a PMA
Subpart C. Subpart C—FDA Action on a PMA
§ 814.40 - Time frames for reviewing a PMA.
§ 814.42 - Filing a PMA.
§ 814.44 - Procedures for review of a PMA.
§ 814.45 - Denial of approval of a PMA.
§ 814.46 - Withdrawal of approval of a PMA.
§ 814.47 - Temporary suspension of approval of a PMA.