21 CFR 803.56 - If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?

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There are 2 Updates appearing in the Federal Register for 21 CFR 803. View below or at eCFR (GPOAccess)
§ 803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
If you are a manufacturer, when you obtain information required under this part that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to us within 1 month of the day that you receive this information. On a supplemental or followup report, you must:
(a) Indicate on the envelope and in the report that the report being submitted is a supplemental or followup report. If you are using FDA form 3500A, indicate this in Block Item H-2;
(b) Submit the appropriate identification numbers of the report that you are updating with the supplemental information (e.g., your original manufacturer report number and the user facility or importer report number of any report on which your report was based), if applicable; and
(c) Include only the new, changed, or corrected information in the appropriate portion(s) of the respective form(s) for reports that cross reference previous reports.

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