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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER H—MEDICAL DEVICES
  6. PART 820—QUALITY SYSTEM REGULATION

21 CFR Part 820 - QUALITY SYSTEM REGULATION

  • CFR
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  1. Subpart A—General Provisions (§§ 820.1 - 820.5)
  2. Subpart B—Quality System Requirements (§§ 820.20 - 820.25)
  3. Subpart C—Design Controls (§ 820.30)
  4. Subpart D—Document Controls (§ 820.40)
  5. Subpart E—Purchasing Controls (§ 820.50)
  6. Subpart F—Identification and Traceability (§§ 820.60 - 820.65)
  7. Subpart G—Production and Process Controls (§§ 820.70 - 820.75)
  8. Subpart H—Acceptance Activities (§§ 820.80 - 820.86)
  9. Subpart I—Nonconforming Product (§ 820.90)
  10. Subpart J—Corrective and Preventive Action (§ 820.100)
  11. Subpart K—Labeling and Packaging Control (§§ 820.120 - 820.130)
  12. Subpart L—Handling, Storage, Distribution, and Installation (§§ 820.140 - 820.170)
  13. Subpart M—Records (§§ 820.180 - 820.198)
  14. Subpart N—Servicing (§ 820.200)
  15. Subpart O—Statistical Techniques (§ 820.250)
Link to an amendment published at 89 FR 7523, Feb. 2, 2024.
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.

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