Title 21

PART 821

Part 821 - Medical Device Tracking Requirements

PART 821 - MEDICAL DEVICE TRACKING REQUIREMENTS Authority:21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374. Source:58 FR 43447, Aug. 16, 1993, unless otherwise noted.

21:8.0.1.1.13.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.13.1.1.1SECTION 821.1
   821.1 Scope.
21:8.0.1.1.13.1.1.2SECTION 821.2
   821.2 Exemptions and variances.
21:8.0.1.1.13.1.1.3SECTION 821.3
   821.3 Definitions.
21:8.0.1.1.13.1.1.4SECTION 821.4
   821.4 Imported devices.
21:8.0.1.1.13.2SUBPART B
Subpart B - Tracking Requirements
21:8.0.1.1.13.2.1.1SECTION 821.20
   821.20 Devices subject to tracking.
21:8.0.1.1.13.2.1.2SECTION 821.25
   821.25 Device tracking system and content requirements: manufacturer requirements.
21:8.0.1.1.13.3SUBPART C
Subpart C - Additional Requirements and Responsibilities
21:8.0.1.1.13.3.1.1SECTION 821.30
   821.30 Tracking obligations of persons other than device manufacturers: distributor requirements.
21:8.0.1.1.13.4SUBPART D
Subpart D - Records and Inspections
21:8.0.1.1.13.4.1.1SECTION 821.50
   821.50 Availability.
21:8.0.1.1.13.4.1.2SECTION 821.55
   821.55 Confidentiality.
21:8.0.1.1.13.4.1.3SECTION 821.60
   821.60 Retention of records.