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2 Responses

  1. Kevin L McMahon
    Kevin L McMahon September 26, 2013 at 9:50 am | | Reply

    Coincidentally (or maybe not), the SEC has just relaxed its regulations against making broad solicitations for investment which might make it easier for some of these ideas to become viable products in less time. While this has the downside of possibly increasing risk at a faster pace it’s always a patient beware world. Heck, even devices with FDA approval have issues and worse. It should be an interesting next 6 months to say the least.

  2. Carrie I. Wyatt
    Carrie I. Wyatt October 2, 2013 at 7:10 am | | Reply

    The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices. The guidance document (PDF – 269KB) provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A , Appendix B and Appendix C .

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