Code of Federal Regulations > Title 21 > Chapter I > Part 814 - PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Mar 03, 2026

Subpart A [§ 814.1 - § 814.19] - Subpart A—General

Subpart B [§ 814.20 - § 814.39] - Subpart B—Premarket Approval Application (PMA)

Subpart C [§ 814.40 - § 814.47] - Subpart C—FDA Action on a PMA

Subpart D - Subpart D—Administrative Review [Reserved]

Subpart E [§ 814.80 - § 814.84] - Subpart E—Postapproval Requirements

Subpart F - Subparts F-G [Reserved]

Subpart H [§ 814.100 - § 814.126] - Subpart H—Humanitarian Use Devices