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Re: [scrumdevelopment] Changing the FDA's "intended use" during development

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  • James Schiel
    The intended use statement can be a problem. However, the intended use usually doesn t change during development of the product as it describes the fundamental
    Message 1 of 3 , Oct 26, 2011
      The intended use statement can be a problem. However, the intended use usually doesn't change during development of the product as it describes the fundamental purpose of the product. From Sprint to Sprint, as long as the Product Owner doesn't incorporate changes that threaten the intended use, there shouldn't be a problem. Also, keep in mind that the 510K can be filed on a release of the software that doesn't actually have to be shipped to anybody, thereby allowing you to get the intended use established and, if necessary, modified while eliminating some of the processing delays.

      Let me know if you'd like to discuss further.

      Jim Schiel

      From: Jon Archer <jon@...>
      Reply-To: Scrum Development <scrumdevelopment@yahoogroups.com>
      Date: Wed, 26 Oct 2011 15:12:30 -0600
      To: Scrum Development <scrumdevelopment@yahoogroups.com>
      Subject: Re: [scrumdevelopment] Changing the FDA's "intended use" during development

       

      I work in an organization that develops software subject to 21 CFR part 11, but we don't do the 510K stuff that comes with devices, and I think it's those that have the "intended use" piece going on (I could definitely be wrong on that, but never bumped into the "intended use" thing). So although I'm not familiar with that particular challenge, I can say that we (an engineering group) in working with our regulatory experts were able to address all the issues that surface initially during our scrum adoption. 


      If it's something one would normally set up front when approaching a project waterfall style then is there any need to stop doing that? Set it as part of release planning perhaps?

      Jon

      On Wed, Oct 26, 2011 at 3:23 AM, Marc Bless <marc.bless@...> wrote:
       

      Hi,


      one of my clients (medical technology) is going to switch to Scrum for their next project. As they have to get all FDA approvals for their product, they are wondering how they could handle the needed "intended use" definition for the FDA. They fear the "intended use" could change with each Sprint so that all product approval processes have to start over and over again.

      Do you have any experience with such situations? How do you handle all this FDA stuff in an agile project? Is it an issue at all?

      Thanks,
      Marc


      --
      Marc Bless
      Agile and Scrum Coach


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