Site Feedback

Title 21

Displaying title 21, up to date as of 7/09/2026. Title 21 was last amended 7/09/2026.
eCFR Content

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.

Learn more about the eCFR, its status, and the editorial process.

Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 814Premarket Approval of Medical Devices814.1 – 814.126
Subpart AGeneral814.1 – 814.19
Subpart BPremarket Approval Application (PMA)814.20 – 814.39
§ 814.20Application.
§ 814.37PMA amendments and resubmitted PMAs.
§ 814.39PMA supplements.
Subpart CFDA Action on a PMA814.40 – 814.47
§ 814.40Time frames for reviewing a PMA.
§ 814.42Filing a PMA.
§ 814.44Procedures for review of a PMA.
§ 814.45Denial of approval of a PMA.
§ 814.46Withdrawal of approval of a PMA.
§ 814.47Temporary suspension of approval of a PMA.
Subpart D—Administrative Review [Reserved]
Subpart EPostapproval Requirements814.80 – 814.84
§ 814.80General.
§ 814.82Postapproval requirements.
§ 814.84Reports.
Subparts F-G [Reserved]
Subpart HHumanitarian Use Devices814.100 – 814.126