Title 21
PART 820
Part 820 - Quality System Regulation
- Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.
- Source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.
| 21:8.0.1.1.12.1 | SUBPART A | Subpart A - General Provisions | |
| 21:8.0.1.1.12.1.1.1 | SECTION 820.1 | 820.1 Scope. | |
| 21:8.0.1.1.12.1.1.2 | SECTION 820.3 | 820.3 Definitions. | |
| 21:8.0.1.1.12.1.1.3 | SECTION 820.5 | 820.5 Quality system. | |
| 21:8.0.1.1.12.2 | SUBPART B | Subpart B - Quality System Requirements | |
| 21:8.0.1.1.12.2.1.1 | SECTION 820.20 | 820.20 Management responsibility. | |
| 21:8.0.1.1.12.2.1.2 | SECTION 820.22 | 820.22 Quality audit. | |
| 21:8.0.1.1.12.2.1.3 | SECTION 820.25 | 820.25 Personnel. | |
| 21:8.0.1.1.12.3 | SUBPART C | Subpart C - Design Controls | |
| 21:8.0.1.1.12.3.1.1 | SECTION 820.30 | 820.30 Design controls. | |
| 21:8.0.1.1.12.4 | SUBPART D | Subpart D - Document Controls | |
| 21:8.0.1.1.12.4.1.1 | SECTION 820.40 | 820.40 Document controls. | |
| 21:8.0.1.1.12.5 | SUBPART E | Subpart E - Purchasing Controls | |
| 21:8.0.1.1.12.5.1.1 | SECTION 820.50 | 820.50 Purchasing controls. | |
| 21:8.0.1.1.12.6 | SUBPART F | Subpart F - Identification and Traceability | |
| 21:8.0.1.1.12.6.1.1 | SECTION 820.60 | 820.60 Identification. | |
| 21:8.0.1.1.12.6.1.2 | SECTION 820.65 | 820.65 Traceability. | |
| 21:8.0.1.1.12.7 | SUBPART G | Subpart G - Production and Process Controls | |
| 21:8.0.1.1.12.7.1.1 | SECTION 820.70 | 820.70 Production and process controls. | |
| 21:8.0.1.1.12.7.1.2 | SECTION 820.72 | 820.72 Inspection, measuring, and test equipment. | |
| 21:8.0.1.1.12.7.1.3 | SECTION 820.75 | 820.75 Process validation. | |
| 21:8.0.1.1.12.8 | SUBPART H | Subpart H - Acceptance Activities | |
| 21:8.0.1.1.12.8.1.1 | SECTION 820.80 | 820.80 Receiving, in-process, and finished device acceptance. | |
| 21:8.0.1.1.12.8.1.2 | SECTION 820.86 | 820.86 Acceptance status. | |
| 21:8.0.1.1.12.9 | SUBPART I | Subpart I - Nonconforming Product | |
| 21:8.0.1.1.12.9.1.1 | SECTION 820.90 | 820.90 Nonconforming product. | |
| 21:8.0.1.1.12.10 | SUBPART J | Subpart J - Corrective and Preventive Action | |
| 21:8.0.1.1.12.10.1.1 | SECTION 820.100 | 820.100 Corrective and preventive action. | |
| 21:8.0.1.1.12.11 | SUBPART K | Subpart K - Labeling and Packaging Control | |
| 21:8.0.1.1.12.11.1.1 | SECTION 820.120 | 820.120 Device labeling. | |
| 21:8.0.1.1.12.11.1.2 | SECTION 820.130 | 820.130 Device packaging. | |
| 21:8.0.1.1.12.12 | SUBPART L | Subpart L - Handling, Storage, Distribution, and Installation | |
| 21:8.0.1.1.12.12.1.1 | SECTION 820.140 | 820.140 Handling. | |
| 21:8.0.1.1.12.12.1.2 | SECTION 820.150 | 820.150 Storage. | |
| 21:8.0.1.1.12.12.1.3 | SECTION 820.160 | 820.160 Distribution. | |
| 21:8.0.1.1.12.12.1.4 | SECTION 820.170 | 820.170 Installation. | |
| 21:8.0.1.1.12.13 | SUBPART M | Subpart M - Records | |
| 21:8.0.1.1.12.13.1.1 | SECTION 820.180 | 820.180 General requirements. | |
| 21:8.0.1.1.12.13.1.2 | SECTION 820.181 | 820.181 Device master record. | |
| 21:8.0.1.1.12.13.1.3 | SECTION 820.184 | 820.184 Device history record. | |
| 21:8.0.1.1.12.13.1.4 | SECTION 820.186 | 820.186 Quality system record. | |
| 21:8.0.1.1.12.13.1.5 | SECTION 820.198 | 820.198 Complaint files. | |
| 21:8.0.1.1.12.14 | SUBPART N | Subpart N - Servicing | |
| 21:8.0.1.1.12.14.1.1 | SECTION 820.200 | 820.200 Servicing. | |
| 21:8.0.1.1.12.15 | SUBPART O | Subpart O - Statistical Techniques | |
| 21:8.0.1.1.12.15.1.1 | SECTION 820.250 | 820.250 Statistical techniques. |