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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 820 - Quality System Regulation |
| Subpart A - General Provisions |
| § 820.1 - Scope. |
| § 820.3 - Definitions. |
| § 820.5 - Quality system. |
| Subpart B - Quality System Requirements |
| § 820.20 - Management responsibility. |
| § 820.22 - Quality audit. |
| § 820.25 - Personnel. |
| Subpart C - Design Controls |
| § 820.30 - Design controls. |
| Subpart D - Document Controls |
| § 820.40 - Document controls. |
| Subpart E - Purchasing Controls |
| § 820.50 - Purchasing controls. |
| Subpart F - Identification and Traceability |
| § 820.60 - Identification. |
| § 820.65 - Traceability. |
| Subpart G - Production and Process Controls |
| § 820.70 - Production and process controls. |
| § 820.72 - Inspection, measuring, and test equipment. |
| § 820.75 - Process validation. |
| Subpart H - Acceptance Activities |
| § 820.80 - Receiving, in-process, and finished device acceptance. |
| § 820.86 - Acceptance status. |
| Subpart I - Nonconforming Product |
| § 820.90 - Nonconforming product. |
| Subpart J - Corrective and Preventive Action |
| § 820.100 - Corrective and preventive action. |
| Subpart K - Labeling and Packaging Control |
| § 820.120 - Device labeling. |
| § 820.130 - Device packaging. |
| Subpart L - Handling, Storage, Distribution, and Installation |
| § 820.140 - Handling. |
| § 820.150 - Storage. |
| § 820.160 - Distribution. |
| § 820.170 - Installation. |
| Subpart M - Records |
| § 820.180 - General requirements. |
| § 820.181 - Device master record. |
| § 820.184 - Device history record. |
| § 820.186 - Quality system record. |
| § 820.198 - Complaint files. |
| Subpart N - Servicing |
| § 820.200 - Servicing. |
| Subpart O - Statistical Techniques |
| § 820.250 - Statistical techniques. |