Title 21, Part 821 — Medical Device Tracking Requirements
10 sections
Section 821.1
Scope.
Section 821.2
Exemptions and variances.
Section 821.3
Definitions.
Section 821.4
Imported devices.
Section 821.20
Devices subject to tracking.
Section 821.25
Device tracking system and content requirements: manufacturer requirements.
Section 821.30
Tracking obligations of persons other than device manufacturers: distributor requirements.
Section 821.50
Availability.
Section 821.55
Confidentiality.
Section 821.60
Retention of records.