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US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 814 — PREMARKET APPROVAL OF MEDICAL DEVICES
Subpart C — FDA Action on a PMA
Federal (United States) · Regulations
Subpart C — FDA Action on a PMA
6 sections
6 sections
21 C.F.R. § 814.40
Time frames for reviewing a PMA.
21 C.F.R. § 814.42
Filing a PMA.
21 C.F.R. § 814.44
Procedures for review of a PMA.
21 C.F.R. § 814.45
Denial of approval of a PMA.
21 C.F.R. § 814.46
Withdrawal of approval of a PMA.
21 C.F.R. § 814.47
Temporary suspension of approval of a PMA.
Subpart C — FDA Action on a PMA | Federal (United States) Regulations | Justis AI