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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
Federal (United States) · Regulations
Part 814 — PREMARKET APPROVAL OF MEDICAL DEVICES
33 sections
5 groups
Subpart A — General
7 sections
Subpart B — Premarket Approval Application (PMA)
3 sections
Subpart C — FDA Action on a PMA
6 sections
Subpart E — Postapproval Requirements
3 sections
Subpart H — Humanitarian Use Devices
14 sections
Part 814 — PREMARKET APPROVAL OF MEDICAL DEVICES | Federal (United States) Regulations | Justis AI