Click the title below for complete guidelines
Table of contents
Subpart A - General Provisions
821.2 Exemptions and variances.
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.
FDA 21 CFR Part 821 Medical Device Tracking Requirements: