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"Stand-alone Software" from a UDI perspective

  • 1.  "Stand-alone Software" from a UDI perspective

    Posted 19-May-2016 17:10

    Hi,

    Could you please explain what is "Stand-alone Software" from a UDI perspective? Do you know of any examples?

    Regards,

    ------------------------------
    Thas Yuwaraj
    ------------------------------


  • 2.  RE: "Stand-alone Software" from a UDI perspective

    Posted 20-May-2016 08:53

    My company creates many stand-alone software products.  You can read about PerFRACTION, DoseCHECK, PlanIQ, 3DVH, SNC Machine and others on our website: Sun Nuclear Corporation

    Regards,

    Rene'

    ------------------------------
    Rene' Hardee
    Regulatory Affairs Specialist III
    Sun Nuclear Corporation
    Melbourne FL
    United States



  • 3.  RE: "Stand-alone Software" from a UDI perspective

    Posted 20-May-2016 09:24

    Stand-alone software is software that does not come bundled within another software application and does not require another software package to run. It is installed on your computer (from a package or downloaded from a website) rather than cloud-based software that runs via your Internet browser. 

    Stand-alone software must comply with the FDA’s UDI Final Rule.  Stand-alone software distributed virtually also requires a UDI in plain text on a “help” or “about” screen.  Software distributed on a CD, DVD or USB flash drive must have a UDI on the label of the device.

    From 21 CFR Part 801:

    Sec. 801.50 Labeling requirements for stand-alone software.

    (a) Stand-alone software that is not distributed in packaged form (e.g., when downloaded from a Web site) is deemed to meet the UDI labeling requirements of this subpart if it complies with the requirements of paragraph (b) of this section and conveys the version number in its production identifier.

    (b) Regardless of whether it is or is not distributed in packaged form, stand-alone software regulated as a medical device must provide its unique device identifier through either or both of the following:

    (1) An easily readable plain-text statement displayed whenever the software is started;

    (2) An easily readable plain-text statement displayed through a menu command (e.g., an "About * * *" command).

    (c) Stand-alone software that is distributed in both packaged form and in a form that is not packaged (e.g., when downloaded from a Web site) may be identified with the same device identifier.

    [78 FR 55818, Sept. 24, 2013]

    ------------------------------
    Lena Cordie
    Qualitas Professional Services
    Watertown MN
    United States



  • 4.  RE: "Stand-alone Software" from a UDI perspective

    Posted 20-May-2016 09:48

    Lena, I generally agree with your assessment, but why would a cloud-based software not be considered a stand-alone software?

    --

    ------------------------------
    Michael Zagorski RAC
    Pittsburgh PA



  • 5.  RE: "Stand-alone Software" from a UDI perspective

    Posted 20-May-2016 17:34

    Hi Lena

    Thanks for your response. Just wondering what is your rationale for saying that cloud-based software is not standalone software? Is there a guidance on this?

    Regards

    Deepthi

    ------------------------------
    Thas Yuwaraj



  • 6.  RE: "Stand-alone Software" from a UDI perspective

    Posted 23-May-2016 09:28

    My rational for excluding cloud-based software as being stand-alone software is that this software is not downloaded onto a user desktop, and it is the responsibility of the software manufacture to update the software on their end and ensure identification and traceability. Users may not be aware of when the cloud-based software changes and they don't have control over the software. This is different from software that is installed onto a desktop from a CD, DVD, USB flash drive or virtually downloaded, where updating the software is under the control of the user. The UDI regulation calls out stand-alone software, which I believe is different from cloud-based software. However, I'm not saying that cloud-based software shouldn't have a UDI. But I am open to hearing other thoughts and ideas on this!

    ------------------------------
    Lena Cordie
    Qualitas Professional Services
    Watertown MN
    United States



  • 7.  RE: "Stand-alone Software" from a UDI perspective

    Posted 23-May-2016 11:42

    I'd be inclined to accept "does not require another software package to run" as the full and complete definition of "stand-alone," having nothing to do with what other software might come bundled with it (as long as it doesn't need the other software in the bundle to run) nor where it is installed---on a user's own stand-alone desktop computer, a user's cell phone, a server owned by an employer of users, or on a computer owned by a third party and which can be accessed and used via an internet connection. (I think latter is essentially what is meant by "the cloud," but I'm not sure.)

    This is just a personal definition, not sure what FDA thinks or what might be generally recognized as "industry standard."

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



  • 8.  RE: "Stand-alone Software" from a UDI perspective

    Posted 24-May-2016 08:05

    Stand-alone software in the cloud should  have a UDI in my opinion. There is always    a "splash" or "about" page in software somewhere that identifies the version/build, license issues, and you need this for customer service, complaint management, recalls, and perhaps MDRs. I'd advise my clients to implement UDI for these products.

    Ginger Cantor, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com






  • 9.  RE: "Stand-alone Software" from a UDI perspective

    Posted 24-May-2016 22:13

    Stand-alone software is a type of a medical device (IEC 62304 uses term Medical Device Software) that is independent of the delivery method (e.g. download, web portal, CD), a platform on which it operates (e.g. desktop, mobile, web, server), or user's interaction with it (e.g. data view only, menus, controls, data transfer, etc). Stand-alone software is a software that is a medical device in its own right. This includes software that is run from the manufacturer's server (i.e. in the cloud). Software maintenance (e.g. updates, modifications) and distribution method are not considerations in defining software as a stand-alone medical device software, just like it does not matter whether you pick up your traditional device at the pharmacy, doctor's office, or delivered via mail.

    Additionally, whether a software is considered to be 'stand-alone' has nothing to do with UDI regulation, but all stand-alone software requires UDI.  

    Managing distribution, and corrections and removals process for software that a user can only access via web link is naturally much simpler compared to other types of devices or other distribution methods. The retrieving portion of the recall may only take me 30 seconds to execute.

    ------------------------------
    Michael Zagorski RAC
    Pittsburgh PA



  • 10.  RE: "Stand-alone Software" from a UDI perspective

    Posted 24-May-2016 21:56

    For the purpose of UDI, FDA defines stand-alone software to be medical software that is itself a medical device, but that is not a component, part, or accessory of a medical device.  Also with specific respect to UDI, FDA includes cloud-based software in the scope of the stand-alone software definition.

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



  • 11.  RE: "Stand-alone Software" from a UDI perspective

    Posted 26-May-2016 15:45

    Kevin and Michael, thanks for bringing us back on point.  As things move forward, I expect there will be other disconnects between the terminology used in the software industry and that used by FDA and the medical device industry. I prefer the term "SaMD," which (I think?) means the same thing, but doesn't stumble over a term that has already been in use by the software industry for decades.

    It is my expectation that most...whatever you want to call thems...will come out of the software industry, not the medical device industry, which is firmly grounded in hardware.  Does anyone here see it differently?

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



  • 12.  RE: "Stand-alone Software" from a UDI perspective

    Posted 26-May-2016 16:39
    Julie,

    Good Day!

    "It is my expectation that most...whatever you want to call thems...will come out of the software industry, not the medical device industry, which is firmly grounded in hardware."

    The term "SaMD" will continue to be used by the IMDRF Working Group N10.  

    The term "standalone software" appears 2 times in the IEC 62304.

    The UDI final rule uses the term "standalone software" as medical software that is itself a MD (not a component, part or accessory of a MD).

    The standalone software used for medical purposes has long been used as a medical device and thus, it seems to have settled in the medical device industry.

    D

     





  • 13.  RE: "Stand-alone Software" from a UDI perspective

    Posted 27-May-2016 08:47

    The latest revision of the IEC 62304:2006 ADM1:2015 (the 2015 amendment) introduced the term "Medical Device Software", which is used 38 times throughout the document including the title and appendices. 

    It appears however, that the terms "Medical Device Software", "SAMD - Software As Medical Device," and "Stand-Alone Software" mean the same thing and are consistent with the definitions provided in earlier posts.

    For software developers, especially those not very familiar with medical device regulations and standards, the terminology can be quite confusing. For many, terms such as 'device', 'design transfer', or even 'design' are confusing or meaningless. You may have a software developer that rewrites half the code and still claim there was no change to "design". 

    ------------------------------
    Michael Zagorski RAC, CQA, CQE
    Pittsburgh PA



  • 14.  RE: "Stand-alone Software" from a UDI perspective

    Posted 27-May-2016 11:25

    Yes, and for me, therein lies much of the terror of the coming tidal wave, particularly if these devices will be developed mostly outside the established medical device industry.

    I would lament the choice of "Medical Device Software" as an appropriate term to refer to the same thing as SaMD.  There is already a lot of software that is part a medical device, rather than being a medical device on its own.  I think most people would assume that this term refers to both and, if not to both, to the former, rather than the latter.  From a purely literate perspective, that assumption is well justified, too.

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



  • 15.  RE: "Stand-alone Software" from a UDI perspective

    Posted 27-May-2016 11:51
    Michael,

    "The latest revision of the IEC 62304:2006 ADM1:2015 (the 2015 amendment) introduced the term "Medical Device Software"

    The term "Medical Device Software" is the title for the standard being the focus of the standard (e.g., IEC 62304:2006).

    The term "medical device software" has been well known for many years at least to those who are familiar with the standard, referring to software as medical device (e.g., standalone software to be used for one or more medical purposes).

    Potential source of confusion: the standard applies to both software as  medical device and software (an embedded or integral part) of the medical device.

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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