FDA 21 CFR Part 821 Medical Device Tracking Requirements

FDA 21 CFR Part 821 Medical Device Tracking Requirements:

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Table of contents

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.

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.

FDA 21 CFR Part 821 Medical Device Tracking Requirements: