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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 B — Premarket Approval Application (PMA)
Federal (United States) · Regulations
Subpart B — Premarket Approval Application (PMA)
3 sections
3 sections
21 C.F.R. § 814.20
Application.
21 C.F.R. § 814.37
PMA amendments and resubmitted PMAs.
21 C.F.R. § 814.39
PMA supplements.
Subpart B — Premarket Approval Application (PMA) | Federal (United States) Regulations | Justis AI