Code of Federal Regulations > Title 21 > Chapter I > Part 807 - PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

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Regulations last checked for updates: May 14, 2025

Title 21 - Food and Drugs last revised: May 12, 2025

All TitlesTitle 21Chapter IPart 807 - PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

Subpart A [§ 807.3 - § 807.3] - Subpart A—General Provisions

Subpart B [§ 807.20 - § 807.39] - Subpart B—Procedures for Device Establishments

Subpart C [§ 807.40 - § 807.41] - Subpart C—Procedures for Foreign Device Establishments

Subpart D [§ 807.65 - § 807.65] - Subpart D—Exemptions

Subpart E [§ 807.81 - § 807.100] - Subpart E—Premarket Notification Procedures

authority: 21 U.S.C. 321,331,351,352,360,360c,360e,360e-4,360i,360j,360bbb-8b,371,374,379k,381,393; 42 U.S.C. 264,271

source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.

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