Part 821 Medical Device Tracking Requirements

Subpart 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 2 × 483
• § 821.25   Device tracking system and content requirements: manufacturer requirements 16 × 483

Subpart C - Additional Requirements and Responsibilities

• § 821.30   Tracking obligations of persons other than device manufacturers: distributor requirements 1 × 483

Subpart D - Records and Inspections

• § 821.50   Availability 1 × 483
• § 821.55   Confidentiality
• § 821.60   Retention of records