21 CFR Part 821
PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS
- PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- 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.
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