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?
Manufacturers must submit a supplemental or followup report within 30 calendar days of receiving previously unavailable required information, electronically, marked as supplemental, citing the original report numbers, and containing only new, changed, or corrected information.
Part 803, Medical Device Reporting · Subpart E, Manufacturer Reporting Requirements
How FDA words it
The opening lines investigators use most when they cite 803.56, from the 483s we hold.
A supplemental report was not submitted to FDA within one month following receipt of information that was not provided when the initial report was submitted.Most used
Recent 483s citing 803.56
- Datascope Corp · Wayne, New JerseyAn individual supplemental report was not submitted to FDA within one month… Jan 21, 2022
- Physio-Control, Inc · Redmond, WashingtonA supplemental report was not submitted to FDA within one month following receipt… Dec 15, 2017
- Epimed International, Inc · Johnstown, New YorkA supplemental report was not submitted to FDA within one month following receipt… Jul 12, 2016
- Terumo Cardiovascular Systems Corporation · Ann Arbor, IndianaA supplemental report was not submitted to FDA within one month following receipt… Jul 11, 2015
- American Medical Systems Innovation · San Jose, CaliforniaA supplemental report was not submitted to FDA within one month following receipt… Apr 3, 2015
The regulation text
§ 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 30 calendar days of the day that you receive this information. You must submit the supplemental or followup report in accordance with the requirements of § 803.12(a). On a supplemental or followup report, you must:
(a)Indicate that the report being submitted is a supplemental or followup report;
(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.
Questions
What does 21 CFR 803.56 require?
Manufacturers must submit a supplemental or followup report within 30 calendar days of receiving previously unavailable required information, electronically, marked as supplemental, citing the original report numbers, and containing only new, changed, or corrected information.
How do FDA investigators word a 803.56 observation?
The most common opening is: “A supplemental report was not submitted to FDA within one month following receipt of information that was not provided when the initial report was submitted.”
Which sections are cited alongside 803.56?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.30 (Design controls), 820.198 (Complaint files), 820.50 (Purchasing controls).