Regulatory Open Forum

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  • 1.  Incident Reporting to US FDA

    Posted 13-May-2020 10:48
    Hello all,

    Per the EU MDR, we are supposed to list incident reporting requirement on the IFU. Do we have similar requirement for the US FDA? Are we supposed to mention that all serious adverse events must be reported to FDA or can we say in general that all serious adverse events should be report by a manufacturer to the appropriate health regulatory agency?

    Shikha Malik


  • 2.  RE: Incident Reporting to US FDA

    Posted 14-May-2020 04:43

    No, this is not a requirement for the United States.  However, the expectation is Warnings and Cautions are clearly identified on the information supplied to the user/patient - such as in the Instructions for Use or guides or labelling.  The concern you might be raising is if you have the same IFU for both the EU and the U.S. having this statement in there now from the requirements of Annex I might introduce confusion for user in U.S.  Though I do not think this would be the case, because adverse events need to be reported in the U.S. as well - in fact it is much stronger in the U.S. as users and patients have the ability to report serious injury or death directly to the FDA.  We have been writing this statement in general - 'report serious incident to your local health authority' since many of the labelling is for many countries and we would not have an IFU per country.

    Richard Vincins RAC
    Vice President Global Regulatory Affairs

  • 3.  RE: Incident Reporting to US FDA

    Posted 14-May-2020 14:58

    Presumably, your question refers to Annex I(23.4)(z) which requires a statement to report serious incidents to the manufacturer and to the Competent Authority, CA.


    This is part of the market surveillance system under the MDR. Under the MDD reports would go to the manufacturer only. Now they go to the Competent Authority as well.


    You, as the manufacturer, must report serious incidents to the CA following the time requirements in Article 87(1). Presumably, the CA will match them with the corresponding report they receive directly. If there is a mismatch the CA will contact you under Article 87(11).


    My recommendation is that you have a procedure in place in the event the CA contacts you. You will want to respond quickly. (You should have procedures to cover the other areas in Article 93 to 100 when the CA may contact you or another economic operator.)


    There are two potential issues to consider in the IFU. One is that Annex I says "serious incidents". This is a technical term in Article 2, so you should decide whether your IFU will define it. The second issue is the identification of the CA. Do you want the IFU to include information on where to report? There is a web page that lists all the CAs.


    The US does not have a corresponding requirement for the IFU. I recommend you include this as EU only to prevent confusion.


    In the US the requirements are in three parts: manufacturer's who receive reports, health facilities who have reportable events, and voluntary public reports. Since all health care facilities in the US have a fully compliant reporting system, there is no need to duplicate the information in the IFU.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States