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New draft MDR reporting guidance


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FDA has released a new draft guidance on MDR reporting. Among the changes is a requirement that both the specification developer and contract manufacturer must report MDRs, unless the contract manufacturer has filed for an exemption. It would seem to me the agency would be flooded with exemptions.

One thing that is emphasized in the regulation (but was always there) is that any decision not to report an adverse event or device malfunction must be recorded by a suitably qualified person (e.g. doctor, nurse, risk manager, biomedical engineer) 21CFR803.20(c)(2). Does anyone have any experience on what qualifies a person to be a risk manager? Currently, I am not certain as to the qualifications of the personnel making this decision, but taking all device malfunctions to the Chief Medical Officer to document his decision would be difficult. I have difficulty getting the biomedical engineer to document his decisions.
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The draft guidance is at

Note that the title of the new Guidance is "Medical Device Reporting for Manufacturers". Thus this guidance normally will not apply to hospitals and other device use-sites.

This however is important for manufacturers, as MDR reporting shortfalls (procedures or lack thereof; mis-classification; failure to report, etc.) are a leading reason for device Warning Letters at present.
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