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  • 1.  Any software in medical device NOT requiring 510(k)?

    Posted 10-Jan-2017 15:04

    In your opinion, is there EVER an occasion when a medical device that contains software (including firmware) would not require a 510(k) submission?  E.g. a Class I, 510(k) exempt device  or OTHER?

    Thank you for any thoughts on this topic.

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    Debra Hutson
    Snohomish WA
    United States
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  • 2.  RE: Any software in medical device NOT requiring 510(k)?

    Posted 10-Jan-2017 17:39

    These might help:

    http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

    http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm401996.pdf

    In some cases, some software is not even a medical device. 

    http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm429674.pdf

    ------------------------------
    Clarisa Tate
    Medical Device, RA & QA
    Bay Area, CA
    USA

    Original Message


  • 3.  RE: Any software in medical device NOT requiring 510(k)?

    Posted 10-Jan-2017 23:30

    If it is a medical device, then the same regulatory paths are potentially open to it as to any other medical device, including 510(k) exempt.  FDA's perspective on when software is a medical device and which path is appropriate for which type of SaMD, and where it might exercise its enforcement discretion, is still evolving.  Clarisa has provided you with links to guidances that should give you some insight on FDA's current thinking and that may help you determine what path is appropriate for your medical device.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com

    Original Message


  • 4.  RE: Any software in medical device NOT requiring 510(k)?

    Posted 07-Feb-2017 13:56
    Thank you all for your thoughtful feedback!

    Yes, it does seem to me that FDA's approach is still evolving and so what might be 'right' today may become unnecessary tomorrow.  I think, rather than leave it to chance, what we may do is make a pre-submission to ensure that FDA agrees with our approach.

    Kind regards,
    Debbie

    ------------------------------
    Debra Hutson
    Maurer & Hutson Consulting
    Snohomish WA
    United States
    ------------------------------

    Original Message


  • 5.  RE: Any software in medical device NOT requiring 510(k)?

    This message was posted by a user wishing to remain anonymous
    Posted 13-Jan-2017 11:29
    This message was posted by a user wishing to remain anonymous

    Yes. One example is Classification 880.6310

    From the FDA product classification:
    MDDS
    A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data.(2) an mdds may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol.This identification does not include devices intended to be used in connection with active patient monitoring.

    Original Message


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