21 CFR 806.20: Records of corrections and removals not required to be reported
Requires device manufacturers and importers to keep records of corrections or removals not reported to FDA, including device identification, event description, reviewed justification for non-reporting, and communications, retained for two years beyond the device's expected life.
Part 806, Medical Devices; Reports of Corrections and Removals · Subpart B, Reports and Records
How FDA words it
The opening lines investigators use most when they cite 806.20, from the 483s we hold.
A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups and reviews by a designated person was not included in the record.Most used
There is no record maintained of a correction or removal action that was not required to be reported to FDA.806.20(a)
Recent 483s citing 806.20
- Neuronetrix Solutions, LLC · Louisville, KentuckyThere is no record maintained of a correction or removal action that was not… Nov 7, 2022
- Custom Healthcare Systems, Inc · Richmond, VirginiaA justification for not reporting the correction or removal action to FDA that… Sep 4, 2019
- Custom Healthcare Systems, Inc. · Richmond, VirginiaA justification for not reporting the correction or removal action to FDA that… Sep 4, 2019
- Clariance Inc · Chicago, IllinoisA justification for not reporting the correction or removal action to FDA that… Jun 4, 2019
- Customer Service Associates, LLC · Winchester, TennesseeA justification for not reporting the conection or removal action to FDA that… Oct 21, 2016
The regulation text
§ 806.20 Records of corrections and removals not required to be reported.
(a)Each device manufacturer or importer who initiates a correction or removal of a device that is not required to be reported to FDA under § 806.10 shall keep a record of such correction or removal.
(b)Records of corrections and removals not required to be reported to FDA under § 806.10 shall contain the following information:
(1)The brand name, common or usual name, classification, name and product code if known, and the intended use of the device.
(2)The unique device identifier (UDI) of the device, or the device identifier, universal product code (UPC), model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number.
(3)A description of the event(s) giving rise to the information reported and the corrective or removal action that has been, and is expected to be taken.
(4)Justification for not reporting the correction or removal action to FDA, which shall contain conclusions and any followups, and be reviewed and evaluated by a designated person.
(5)A copy of all communications regarding the correction or removal.
(c)The manufacturer or importer shall retain records required under this section for a period of 2 years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. Records required to be maintained under paragraph (b) of this section must be transferred to the new manufacturer or importer of the device and maintained for the required period of time.
[62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998; 78 FR 58821, Sept. 24, 2013]
Questions
What does 21 CFR 806.20 require?
Requires device manufacturers and importers to keep records of corrections or removals not reported to FDA, including device identification, event description, reviewed justification for non-reporting, and communications, retained for two years beyond the device's expected life.
How do FDA investigators word a 806.20 observation?
The most common opening is: “A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups and reviews by a designated person was not included in the record.”
Which sections are cited alongside 806.20?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.50 (Purchasing controls), 820.90 (Nonconforming product).