Regulatory Open Forum

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  • 1.  Adverse Event Report Exemption

    This message was posted by a user wishing to remain anonymous
    Posted 16-Mar-2017 09:36
    This message was posted by a user wishing to remain anonymous

    Hello Regulatory friends,

    I have some questions on the requirements to inform the FDA as a manufacturer about adverse event information. In 21 CFR 803.22(b)(2), it states,"When you receive reportable event information in error, you must forward this information to us with a cover letter explaining that you did not manufacture or import the device in question."  

    My questions then as they relate to that statement are: 1) Where would I send my cover letter? and 2) Can anyone give me an example of how this would be applicable?

    Thank you for your feedback in advance.

  • 2.  RE: Adverse Event Report Exemption

    Posted 17-Mar-2017 10:42
    Honestly, in all the time I had oversight for complaints we never did this. Instead, we forwarded it on to the actual manufacturer and let them deal with it.

    I guess if the rare case where you KNEW it was not your device but could not determine who's it actually was, this might be appropriate. In which case, I'd tend to just send to a higher level OSB contact and let them sort it out.


    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States

  • 3.  RE: Adverse Event Report Exemption

    Posted 21-Mar-2017 10:49
    Edited by John Minier 21-Mar-2017 10:51
    I recommend following the regulation and forwarding the AE report to MEDWATCH:

    FDA Safety Information and Adverse Event Reporting Program

    Food and Drug Administration

    5600 Fishers Lane

    Rockville, MD 20852-9787

    If you know the actual manufacturer, let Medwatch know that.  They will then forward the AE to that company.

    Keep a copy of the report you received and your cover letter in your complaint files along with your investigation and analysis.

    I have seen this occur where an AE is sent on an implant to the wrong manufacturer based only on an image of the implant.  Your engineers may be able to tell if it is a competitor's implant.  Other than that you can go through your shipping records to see if your company sold a device like the one in question to that center. 

    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    Highland Mills, NY
    United States