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  • 1.  Design control for Non-Device-MDDS component that is part of a medical device

    This message was posted by a user wishing to remain anonymous
    Posted 26-Feb-2021 08:56
    This message was posted by a user wishing to remain anonymous

    Hi All,

    Is design control needed for a non-device MDDS (software) that is part of a medical device? Based on 520(o)(1)(D), it looks like there is no design control requirement for non-device MDDS (software) component, even if it is part of a medical device. Please share your thoughts.

    Per section "520(o)(1)(D) of the Federal Food, Drug, and Cosmetic Act:
    Software functions that are solely intended to transfer, store, convert formats, and display medical device data or medical imaging data, are not devices and are not subject to FDA regulatory requirements applicable to devices. The FDA describes these software functions as "Non-Device-MDDS."

    Thanks in advance



  • 2.  RE: Design control for Non-Device-MDDS component that is part of a medical device

    Posted 27-Feb-2021 06:00
    Edited by Richard Vincins 01-Mar-2021 05:09
    Hello Anon,

    The FDA has stated they are not regulating MDDS, though may be done at discretion depending on the software and claims being made.  So in essence, as not regulated, there is no requirement to complete design controls.  However, if this non-device MDDS software is part of a medical device, you may still need to do a minimum number of items like risk management, interoperability, configuration management, or change control.  It might be recommended to treat this non-device MDDS software as an OTS software and apply the respective risk assessment from the FDA guidance document for OTS software: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices.  It might give some thoughts and insight on what might need to document for this non-device MDDS.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Design control for Non-Device-MDDS component that is part of a medical device

    Posted 27-Feb-2021 13:13

    Dear Anon,

     

    MDDSs are NOT medical Devices and are NOT regulated by the FDA.

     

    Design Controls are an FDA regulation.

     

    Therefore Design Controls are NOT legally required for an MDDS.

     

    Having said that, you have a Quality or ethical obligation to your customers and their patients to provide a product that meets its intended use and does not represent a potential harm to users or patients.  If Design Controls will help, it, like the use of risk management, it would be an excellent tool to use to ensure this is true.  However you have no legal obligation under FDA law to do so.

    I hope that helps.

     

    Lee

    Lee Leichter

    President

    P/L Biomedical

    10882 Stonington Avenue

    Fort Myers, FL 33913 USA

    Office: +1-239-244-1448

    Cell: +1-239-994-6488

    Email: leichter@plbiomedical.com

     

     




    Original Message


  • 4.  RE: Design control for Non-Device-MDDS component that is part of a medical device

    Posted 28-Feb-2021 05:01
    Just an additional thought here. 

    Aren't some MDDS considered medical devices by FDA and  still regulated?

    Although it is a 510k exempt MDDS device, it appears that FDA  product code OUG is a regulated medical device since it still appears to require GMPs.  

    But maybe that's a separate issue?

    See link below from FDA. 





    Original Message


  • 5.  RE: Design control for Non-Device-MDDS component that is part of a medical device

    Posted 28-Feb-2021 07:33

    Dallas,

     

    That is a relic from before the 21st Century Cures Act was integrated into FDA regulation within the last year.  If it meets the definition, currently updated and accurate in the FDA guidance documents that deal with this, it is not regulated at all.

     

    See Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff (fda.gov) and Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (fda.gov).

     

     

    Lee

     




    Original Message


  • 6.  RE: Design control for Non-Device-MDDS component that is part of a medical device

    This message was posted by a user wishing to remain anonymous
    Posted 01-Mar-2021 09:39
    This message was posted by a user wishing to remain anonymous

    If it works with a medical device, you may want to consider assessing the impact on the safety and efficacy of the medical device, through the questions and the Multifunctional product guidance. this is different from the off-the-shelf software guidance, but according to a podcast that I heard on Medical Device Made Easy, this guidance follows the off-the-shelf software guidelines from 62304 pretty closely.
    Original Message


  • 7.  RE: Design control for Non-Device-MDDS component that is part of a medical device

    Posted 04-Mar-2021 21:17
    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-function-device-products-policy-and-considerations


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    AnaCiric
    RA/QA Specialist
    Singapore
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    Original Message


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