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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 803 - PART 803—MEDICAL DEVICE REPORTING
  • Subpart A [§ 803.1 - § 803.19] - Subpart A—General Provisions
  • Subpart B [§ 803.20 - § 803.23] - Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports
  • Subpart C [§ 803.30 - § 803.33] - Subpart C—User Facility Reporting Requirements
  • Subpart D [§ 803.40 - § 803.42] - Subpart D—Importer Reporting Requirements
  • Subpart E [§ 803.50 - § 803.58] - Subpart E—Manufacturer Reporting Requirements
authority: 21 U.S.C. 352,360,360i,360j,371,374
source: 79 FR 8846, Feb. 14, 2014, unless otherwise noted.
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