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  • 1.  510 (k) decision for already marketed device due to change in production process.

    Posted 07-Feb-2022 05:43
    Dear RA experts,

    If we have a change in the production  process of already marketed device via a 510 (k) and the process do not have any impact on the device safety and performance and also we do not have a change in the product except the production process, do we require the new 510 (k) registration because of this change?

    As per my information from the document Deciding When to Submit a 510(k) for a Change to an Existing Device, this change of process is not mentioned, so we do not require new 510 (k) registration in this case, if i have understood right.

    I would really appreciate your valueable comments.

    Best Regards,

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    Rabel Talpur
    Freiburg
    Germany
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  • 2.  RE: 510 (k) decision for already marketed device due to change in production process.

    Posted 07-Feb-2022 08:58
    With respect to manufacturing changes, a key narrative I find particularly useful from the aforesaid guidance is:

    "...a manufacturer should consider the impact of all manufacturing changes on device labeling, technology/engineering/performance, and/or materials. If the manufacturing change affects any of these three areas, manufacturers should evaluate the impact of the resulting labeling, technology/engineering/performance, or material change using the appropriate flowcharts and companion text. Specifically, consideration should be given to those devices for which manufacturing information was submitted in the most recently cleared 510(k) in order to assist in the characterization of the device and technology, such as bioresorbables, polymers, and biological fixation type devices. When manufacturing changes do not impact device labeling, technology/engineering/performance, and/or materials, there is no need to use the flow charts and their companion text to document the decision not to submit a new 510(k)..."

    That said, some manufacturing processes indirectly impact these factors in ways that may not be immediately obvious.  For example, reduction of a sterile device's SAL would outright generally require a new 510(k).  Accordingly, the specific nature of the manufacturing change needs to be duly considered in its own right to assure proper application of the principles from the FDA narrative above.

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: 510 (k) decision for already marketed device due to change in production process.

    Posted 08-Feb-2022 07:29
    Hello Rabel,

    Agree with Kevin that some changes to a manufacturing process may have an impact on the safety or efficacy (performance) of a device and needs to be reviewed from that context.  If going through the flowchart there is nothing specific to changes in manufacturing process, however specifications, materials, or other characteristics may change.  Also do not only look at manufacturing process, but the entire product realisation process.  Because if there was a change in material it may seem negligible, but as Kevin mentions it may have a significant impact on the sterilisation process and cause the sterility to be affected which may have an impact on the regulatory status.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


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