21 CFR 900.23 - Evaluation.

§ 900.23 Evaluation.

FDA shall evaluate annually the performance of each certification agency. The evaluation shall include the use of performance indicators that address the adequacy of program performance in certification, inspection, and enforcement activities. FDA will also consider any additional information deemed relevant by FDA that has been provided by the certification body or other sources or has been required by FDA as part of its oversight mandate. The evaluation also shall include a review of any changes in the standards or procedures in the areas listed in §§ 900.21(b) and 900.22 that have taken place since the original application or the last evaluation, whichever is most recent. The evaluation shall include a determination of whether there are major deficiencies in the certification agency's regulations or performance that, if not corrected, would warrant withdrawal of the approval of the certification agency under the provisions of § 900.24, or minor deficiencies that would require corrective action.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 19-May-2018 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 900 after this date.

  • 2018-04-02; vol. 83 # 63 - Monday, April 2, 2018
    1. 83 FR 13863 - Medical Devices; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 2, 2018.
      21 CFR Parts 890, 900, 1020, and 1040
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