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Federal Register :: Mobile Medical Applications; …

    https://www.federalregister.gov/documents/2013/09/25/2013-23293/mobile-medical-applications-guidance-for-industry-and-food-and-drug-administration-staff
    Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority. Many mobile apps are not medical devices (meaning such mobile apps do not meet the definition of a device under section 2… See more

Federal Register :: Changes to Existing Medical …

    https://www.federalregister.gov/documents/2019/09/27/2019-21001/changes-to-existing-medical-software-policies-resulting-from-section-3060-of-the-21st-century-cures
    Only official editions of the Federal Register provide legal notice to the public and judicial notice to the courts under 44 U.S.C. 1503 & 1507 . Learn ... including …

Device Software Functions Including Mobile Medical …

    https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications
    The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps. The Policy for Device …

Policy for Device Software Functions and Mobile …

    https://www.fda.gov/media/80958/download
    and Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff Document issued on September 28, 2022. ... of the Federal Food, Drug, and Cosmetic

FDA Regulation of Mobile Medical Apps | Regulatory …

    https://jamanetwork.com/journals/jama/fullarticle/2687221
    FDA determination that a product developer or manufacturer has met the high regulatory standard for demonstrating clinical benefit and safety (when agency clearance …

FDA Regulation of Mobile Medical Apps - American Bar …

    https://www.americanbar.org/groups/litigation/committees/products-liability/practice/2017/fda-regulation-of-mobile-medical-apps/
    This has garnered a federal-level response by both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). In February 2015, the …

April 22, 2021 MY01 Inc. Anthony Sirgi Regulatory …

    https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210525.pdf
    concerning your device in the Federal Register. ... guidance documents "Policy for Device Software Functions and Mobile Medical Applications" and "Medical Device Data …

Draft Guidance for Industry and Food and Drug …

    https://www.cdc.gov/cliac/docs/addenda/cliac0811/T_addendum_FDA_Draft_Guidance_for_Mobile_Medical_Devices.pdf
    C. Mobile Medical Application (Mobile Medical App) For purposes of this guidance, a "mobile medical app" is a mobile app that meets the definition of "device" in section …

Medical Applications and Forms | FMCSA - Federal …

    https://www.fmcsa.dot.gov/medical/driver-medical-requirements/medical-applications-and-forms
    Medical Applications and Forms Medical Examinations The expiration date on the Medical Examination Report Form, MCSA-5875, Medical Examiner's Certificate, …

Mileage Reimbursement Guide - MAS

    https://www.medanswering.com/documents/Doc-MAS_Public_Site--2013-12-10-13-02-52.pdf
    Medical Answering Services may adjust your claim if expenses exceed Federal Per Diem limits or exclude receipts. For any questions you have concerning your …



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