Skip to main content

FDA Regulations: TITLE 21--FOOD AND DRUGS SUBCHAPTER H - MEDICAL DEVICES - PART 820 QUALITY SYSTEM REGULATION

FDA Regulations: TITLE 21--FOOD AND DRUGS SUBCHAPTER H - MEDICAL DEVICES - PART 820 QUALITY SYSTEM REGULATION

Click on the blue link for more information.

  TITLE 21--FOOD AND DRUGS

SUBCHAPTER H - MEDICAL DEVICES

 
PART 820 QUALITY SYSTEM REGULATION
 
 

   Subpart A -- General Provisions
   Subpart B -- Quality System Requirements
   Subpart C -- Design Controls
   Subpart D -- Document Controls
   Subpart E -- Purchasing Controls
   Subpart F -- Identification and Traceability
   Subpart G -- Production and Process Controls
   Subpart H -- Acceptance Activities
   Subpart I -- Nonconforming Product
   Subpart J -- Corrective and Preventive Action
   Subpart K -- Labeling and Packaging Control
   Subpart L -- Handling, Storage, Distribution, and Installation
  Subpart M -- Records
   Subpart N -- Servicing
   Subpart O -- Statistical Techniques
   

Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383.
Source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.


Author Information