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  • 1.  Change in Manufacturing Method

    Posted 08-Nov-2020 22:07
    Greetings !!

     

    I would like to understand the regulatory strategy involved for manufacturing method changes such as manual process to automatic process for a class II device in the US. Does this manufacturing change alone assuming no changes in design, performance specifications and material will trigger a 510(k)? Is there any guidance document which I can refer to ?

     

    I am wondering what would be the impact of this change in the EU looking at upcoming EU MDR if it is a class IIb product in the EU.


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    Shikha Malik
    Regulatory Affairs Specialist II
    Dallas TX
    United States
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  • 2.  RE: Change in Manufacturing Method

    Posted 09-Nov-2020 01:58
    Shikha,

    There is an FDA guidance document for when to consider a new 510(k) application needed for any type of change to a cleared medical device, here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.  The guidance does not specifically talk about changes in manufacturing or what type of changes in manufacturing would need a new 510(k) submission.  Many of the questions are around impact to safety and efficacy from the resulting changes or changes wanting to be made.  What you need to do is look at the overall changes of the manufacturing, determine the impact the manufacturing changes are making on the finished device, and then determine if a new 510(k) would be needed or a letter to file.  In general, because FDA performs routine inspections of manufacturers, there is not too much manufacturing information included in a 510(k) submission.  So in most cases a change in manufacturing would not require a new 510(k) submission, only if the change in manufacturing is resulting in new materials, new specifications, or changes to the functional use of the device.  Ensure to use the guidance document as a guide and critically think about the changes being made.

    For the EU MDR this change could have an impact, there is also a NBOG document could be used.  Your Notified Body would be the best to contact regarding any manufacturing change to determine if notification needs to be made, because these are handled and managed differently in the EU.  There is more review conducted of the manufacturing activities as part of the technical documentation.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Change in Manufacturing Method

    Posted 09-Nov-2020 09:02
    Hi Shikha,

    Until and unless the change in manufacturing process do not impact the safety and performance of the device, No 510(k) is required to be submitted. However, you will have to validate the new manufacturing process to ensure that the outcome of the new manufacturing process is consistent with the old manufacturing process. The changes and the validations should be summarized in a note to file.  For EU, a manufacturing change should be notified to the EU notified body even though if the process has been validated. 

    Thank you,
    Shubhajit

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    Shubhajit Mitra
    Senior Regulatory Affairs Specialist
    Hopkinton MA
    United States
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    Original Message


  • 4.  RE: Change in Manufacturing Method

    Posted 09-Nov-2020 12:34
    Generally manufacturing changes that do not impact the design, safety or effectiveness do not require a new 510(k). However, you should make sure to do a robust assessment and document the results of the assessment, as it can be very easy to add risks or inadvertently change the design when making manufacturing process improvements.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 5.  RE: Change in Manufacturing Method

    Posted 10-Nov-2020 04:02
    If it is a class IIb device under MDD and the transitional provisions of the MDR are going to be used (article 120.3) it is beneficial to also take into account the Guidance MDCG 2020-3 on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD into account. 
    This guidance document provides in its Annex several flowcharts based on NBOG's Best Practice Guide 2014-3: "Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System" Richard already mentioned in his reply.

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
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    Original Message


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