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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
21 CFR Subpart C
21 CFR Subpart C
FDA Action on a PMA
June 25, 2020
§
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
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