21 CFR 803.53 - If I am a manufacturer, in which circumstances must I submit a 5-day report?

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There are 2 Updates appearing in the Federal Register for 21 CFR 803. View below or at eCFR (GPOAccess)
§ 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report?
You must submit a 5-day report to us, on Form 3500A or an electronic equivalent approved under § 803.14, no later than 5 work days after the day that you become aware that:
(a) An MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. You may become aware of the need for remedial action from any information, including any trend analysis; or
(b) We have made a written request for the submission of a 5-day report. If you receive such a written request from us, you must submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. We may extend the time period stated in the original written request if we determine it is in the interest of the public health.

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-02-14; vol. 79 # 31 - Friday, February 14, 2014
    1. 79 FR 8832 - Medical Device Reporting: Electronic Submission Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This final rule is effective August 14, 2015 (see also section IX of this document).
      21 CFR Part 803

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 803 after this date.

  • 2014-02-14; vol. 79 # 31 - Friday, February 14, 2014
    1. 79 FR 8832 - Medical Device Reporting: Electronic Submission Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This final rule is effective August 14, 2015 (see also section IX of this document).
      21 CFR Part 803