Part 814. PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES

• 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