Part 821 — Medical Device Tracking Requirements
Current through Sep 8, 2026
Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374.
Source: 58 FR 43447, Aug. 16, 1993, unless otherwise noted.
Sections
- § 821.1 Scope.
- § 821.2 Exemptions and variances.
- § 821.3 Definitions.
- § 821.4 Imported devices.
- § 821.20 Devices subject to tracking.
- § 821.25 Device tracking system and content requirements: manufacturer requirements.
- § 821.30 Tracking obligations of persons other than device manufacturers: distributor requirements.
- § 821.50 Availability.
- § 821.55 Confidentiality.
- § 821.60 Retention of records.