21 CFR 820.86 - Acceptance status.

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§ 820.86 Acceptance status.

Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed.

Title 21 published on 13-Apr-2017 03:05

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 820 after this date.

  • 2016-04-25; vol. 81 # 79 - Monday, April 25, 2016
    1. 81 FR 24041 - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Extension of Comment Period
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification; extension of comment period.
      FDA is extending the comment period on the document published March 4, 2016 (81 FR 11477). Submit either electronic or written comments by June 3, 2016.
      21 CFR Part 820