Home › CFR › Title 21 › Part 82121 CFR Part 821 — Medical Device Tracking RequirementsSubpart A — General Provisions§ 821.1— Scope.§ 821.2— Exemptions and variances.§ 821.3— Definitions.§ 821.4— Imported devices.Subpart B — Tracking Requirements§ 821.20— Devices subject to tracking.§ 821.25— Device tracking system and content requirements: manufacturer requirements.Subpart C — Additional Requirements and Responsibilities§ 821.30— Tracking obligations of persons other than device manufacturers: distributor requirements.Subpart D — Records and Inspections§ 821.50— Availability.§ 821.55— Confidentiality.§ 821.60— Retention of records.