Regulatory Open Forum

 View Only

  • 1.  Reporting a Correction and Removal under Part 803

    This message was posted by a user wishing to remain anonymous
    Posted 15-Feb-2017 08:57
    This message was posted by a user wishing to remain anonymous

    Part 806 allows for reporting a correction or removal under part 803.  Does anyone have experience with this?  What type of C&R would you report under part 803?



  • 2.  RE: Reporting a Correction and Removal under Part 803

    Posted 15-Feb-2017 10:36

    While it is allowed under the regulation, it is a bad idea. There is a least one Warning Letters stating that since the MDR form doesn’t contain all the required elements of a report under 806.10, the Investigator determine the company had not made an 806 report.

     

    The other problem is the 803 reports and the 806 reports go to different places – headquarters and the District Office.

     

    The best practice is to send two reports and cite the report number of the other report.



    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 3.  RE: Reporting a Correction and Removal under Part 803

    Posted 15-Feb-2017 11:22
    It seems reasonable to me, if the part 806 report requirements can be incorporated into the part 803 report, that this would be a possible means to comply with part 806 for corrective maintenance (see my previous post).

    ------------------------------
    Peter Ohanian RAC
    Principal Consultant
    Halloran Consulting Group
    Windham NH
    United States
    ------------------------------

    Original Message


  • 4.  RE: Reporting a Correction and Removal under Part 803

    Posted 15-Feb-2017 11:36

    I agree that it is reasonable, but there is a danger of making a mistake. It also means using the free form sections of the Part 803 report. In eSubmitter, Block H9 has a place for the C&R report number, but they refer to it by the section if the FD&CA, not by the part in regulation.

     

    In any case, here is an excerpt from an August 10, 2010 Warning Letter to Starion Instruments Corp.

     

    “Failure to submit any report required by paragraph 21 CFR §806.10(a) within ten working days of initiating such corrections or removal, as required by 21 CFR §806.10(b).

     

    “We have reviewed your response and have concluded that it is inadequate because the devices were falling apart or breaking during normal use and this poses a risk to health. In addition, the firm's own risk analysis identified this type of hazard (broken parts) as posing a serious risk. Therefore, the removal of the defective products does not meet the definition of a market withdrawal. The firm's second rationale for not reporting these events under 21 CFR Part 806 is also inadequate in that all of the information required under 21 CFR Part 806 was not submitted with the MDR.”



    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 5.  RE: Reporting a Correction and Removal under Part 803

    Posted 16-Feb-2017 10:03
    I think one of the keys here is the statement in the warning letter that "the devices [plural] were falling apart..." This implies to me that they were trying to use MDR reports to cover a systematic correction of multiple parts. I can see where FDA would frown on this.

    However, we have used 803 to report corrections on a single piece of capital equipment (say a PCB failed during a procedure and needed to be replaced) where the correction had been completed and the issue was not systemic.

    g-

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

    Original Message


  • 6.  RE: Reporting a Correction and Removal under Part 803

    Posted 16-Feb-2017 13:33

    I agree with  Dan. File under 806, you'll be much safer.




    Original Message


  • 7.  RE: Reporting a Correction and Removal under Part 803

    Posted 15-Feb-2017 12:31

    When promulgating the regulations in Part 806, FDA stated that the relationship between Part 806 and the MDR regulation warrants clarification so as to “avoid unnecessary duplication”. This is because section 519(f)(2) of the FD&C act prohibits FDA from requiring a report of correction or removal if the same information has been required and already submitted under MDR.

     

    But similar to Dan's comments, FDA asserted that for practical intents and purposes, there is not expected to be much overlap between the Part 806 reporting requirements versus the Part 803 reporting requirements.  FDA cited the fundamentally different intentions and corresponding logistics for the two regulations as the basis for this assertion. For example, an MDR report would only rarely address an associated correction or removal since a correction/removal hasn’t typically happened yet within the MDR reporting timeframes.

     

    Yet, an example where FDA says there would be overlap is a 5-day MDR report. This is because those are associated with MDR-reportable events that also require remedial action.  FDA said that by linking Parts 803 and 806 in this case, it means that information concerning the correction/removal “will necessarily be submitted under MDR, and consequently would not need to be resubmitted under part 806”.  FDA also said that in the rare event where a routine (i.e., 30-day) MDR report contains information on a correction/removal taken, then no additional Part 806 report needs to be submitted.

     

    But to echo what Dan said, firms need to be careful when managing these provisions [i.e., 806.10(f)] so as to avoid preventable mishaps like the one cited in the Warning Letter.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------

    Original Message


Related Content