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  • 1.  FDA Reporting and Recalls

    This message was posted by a user wishing to remain anonymous
    Posted 11-Apr-2017 08:33
    This message was posted by a user wishing to remain anonymous

    Hi,

    Could anybody advise on the reporting and recall for  Radiation Emitting Electronic Products with potential for adverse event and requiring design correction. Should this follow reporting under 21 CFR 1003.20 and 1004.2 , - Notification of defect and correction or a mandatory reporting under 21 CFR 803 by submitting 3500A or a Base line report ?

    Thanks


  • 2.  RE: FDA Reporting and Recalls

    Posted 12-Apr-2017 07:13
    Hello there,

    If it is an event for an electronic radiation emitting device that is also a medical device, then report to FDA only under 3500A. FDA has been clear about that.

    If it is something more in the consumer realm or not regulated as a device (e.g., a microwave oven or perhaps a cabinet Xray system used only in an analytical test lab), then report to FDA under the electronic reporting regulations.

    Do pay attention to any additional requirements under the Electronic Product Regulations for customer communications if you end up with a recall. Work with your district on that, since there are slightly different requirements for what the content of those are. You might need to do both and it is grey. 

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    715-307-1850





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