Title 21
PART 821
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.
| 21:8.0.1.1.13.1 | SUBPART A | Subpart A - General Provisions | |
| 21:8.0.1.1.13.1.1.1 | SECTION 821.1 | 821.1 Scope. | |
| 21:8.0.1.1.13.1.1.2 | SECTION 821.2 | 821.2 Exemptions and variances. | |
| 21:8.0.1.1.13.1.1.3 | SECTION 821.3 | 821.3 Definitions. | |
| 21:8.0.1.1.13.1.1.4 | SECTION 821.4 | 821.4 Imported devices. | |
| 21:8.0.1.1.13.2 | SUBPART B | Subpart B - Tracking Requirements | |
| 21:8.0.1.1.13.2.1.1 | SECTION 821.20 | 821.20 Devices subject to tracking. | |
| 21:8.0.1.1.13.2.1.2 | SECTION 821.25 | 821.25 Device tracking system and content requirements: manufacturer requirements. | |
| 21:8.0.1.1.13.3 | SUBPART C | Subpart C - Additional Requirements and Responsibilities | |
| 21:8.0.1.1.13.3.1.1 | SECTION 821.30 | 821.30 Tracking obligations of persons other than device manufacturers: distributor requirements. | |
| 21:8.0.1.1.13.4 | SUBPART D | Subpart D - Records and Inspections | |
| 21:8.0.1.1.13.4.1.1 | SECTION 821.50 | 821.50 Availability. | |
| 21:8.0.1.1.13.4.1.2 | SECTION 821.55 | 821.55 Confidentiality. | |
| 21:8.0.1.1.13.4.1.3 | SECTION 821.60 | 821.60 Retention of records. |