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  • 1.  MDR Remedial Action Exemption

    Posted 31-Aug-2016 10:12

    Good morning,

    My Director shared this FDA guidance from 9/26/2001. I am not familiar with this guidance nor have I used it. Does anyone have experience with the REA? Is it still in use? What are the advantages or disadvantages? Thank you in advance.

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    Jonathan Kovach MBA
    Vice President, QA/RA
    Spacelabs Healthcare, Inc.
    Sammamish WA
    United States
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  • 2.  RE: MDR Remedial Action Exemption

    Posted 02-Sep-2016 09:06

    This guidance falls into the variances allowed under 803.19. These are discussed in the July 9, 2013 draft guidance Medical Device Reporting for Manufacturers

    There are, to the best of my knowledge, no published data on the number of Remedial Action Exemption (RAE) requests and the number of approvals. You can always ask for the exemption. If granted, you come out ahead; if not nothing changes.

    Another interesting exemption covered by a guidance document (UCM072102) Alternative Summary Reporting (ASR). In this case, you don’t file an MDR for every event, but only a subset of the data required by the MDR regulation quarterly, semiannually or annually. Presumably, the transmission is out the current eMDR requirements. Again, I don’t know of any data.

    A third one is the relationship between a specification developer and a contract manufacturer. Since both parties are manufacturers, they must both submit MDRs for the same event. However, if the parties agree that only one should submit the MDR, they can ask for a variance.

    Also, you can ask for a variance in the time to submit. A January 3, 2012 Warning Letter to Thoratec Corporation says, “Under the authority of 21 CFR §803.19(e), your firm was granted an exemption from the 30 calendar day reporting timeframe required by 21 CFR §803.50(a)(1) for events that your firm receives from the INTERMACS Registry. However, your firm did not submit an MDR to FDA within the 90 calendar day timeframe for the following [complaint].”

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    Dan O'Leary
    Swanzey NH
    United States

    Original Message


  • 3.  RE: MDR Remedial Action Exemption

    Posted 02-Sep-2016 11:09
    Jon,

    Is it still in use? 

    YES

    What are the advantages or disadvantages?

    Advantage: A firm can use RAE to deal with many events (e.g. for those events withheld internally without submitting MDRs and without reasonable justification).

    Disadvantages: it is not reasonable to play snowballing with potential events subject to MDRs.   

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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    Original Message