21 CFR 820.80 - Receiving, in-process, and finished device acceptance.

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§ 820.80 Receiving, in-process, and finished device acceptance.

(a)General. Each manufacturershallestablish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.

(b)Receiving acceptance activities. Each manufacturershallestablish and maintain procedures for acceptance of incoming product. Incoming productshall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.

(c)In-process acceptance activities. Each manufacturershallestablish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented.

(d)Final acceptance activities. Each manufacturershallestablish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:

(1) The activities required in the DMR are completed;

(2) the associated data and documentation is reviewed;

(3) the release is authorized by the signature of a designated individual(s); and

(4) the authorization is dated.

(e)Acceptance records. Each manufacturershall document acceptance activities required by this part. These records shall include:

(1) The acceptance activities performed;

(2) the dates acceptance activities are performed;

(3) the results;

(4) the signature of the individual(s) conducting the acceptance activities; and

(5) where appropriate the equipment used. These records shall be part of the DHR.

Title 21 published on 2015-12-03

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

Title 21 published on 2015-12-03.

No entries appear in the Federal Register after this date, for 21 CFR Part 820.