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Mobile Medical Applications Draft Guidance; Public …

    https://www.federalregister.gov/documents/2011/08/12/2011-20574/mobile-medical-applications-draft-guidance-public-workshop
    For purposes of the draft guidance and the public workshop discussion, a “mobile medical app” is a mobile application that meets the definition of “device” in section 201 (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) ( 21 U.S.C. 321 (h) ) [ 1] ; and either: Is used as an accessory to a … See more

Policy for Device Software Functions and Mobile Medical …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications
    Policy for Device Software Functions and Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff September 2022. Policy …

Mobile Medical Applications Draft Guidance; Public …

    https://www.federalregister.gov/documents/2011/09/06/2011-22674/mobile-medical-applications-draft-guidance-public-workshop-correction
    The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, August 12, 2011 (76 FR 50231). The document …

FDA Holds Workshop on Mobile Medical Applications Draft …

    https://www.beckershospitalreview.com/healthcare-information-technology/fda-holds-workshop-on-mobile-medical-applications-draft-guidance.html
    The U.S. Food and Drug Administration recently held a public workshop on its Mobile Medical Applications Draft Guidance that was released in July.

PRESENTATION TO FDA Public Workshop - Mobile Medical …

    https://brand.amia.org/m/704fd0a956619db/original/AMIA-Advises-FDA-on-Clinical-Decision-Support.pdf
    FDA Public Workshop - Mobile Medical Applications Draft Guidance September 12-13, 2011 Meryl Bloomrosen, Vice President for Public Policy and Government Relations …

Draft Guidance for Industry and Food and Drug …

    https://www.federalregister.gov/documents/2011/07/21/2011-18537/draft-guidance-for-industry-and-food-and-drug-administration-staff-mobile-medical-applications
    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent …

Mobile Medical Applications; Guidance for Industry and …

    https://www.federalregister.gov/documents/2013/09/25/2013-23293/mobile-medical-applications-guidance-for-industry-and-food-and-drug-administration-staff
    The guidance represents the Agency's current thinking on mobile medical applications. It does not create or confer any rights for or on any person and does not …

Public Workshop on Patient-Focused Drug …

    https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-patient-focused-drug-development-developing-and-submitting-proposed-draft-guidance
    The purpose of this public workshop is to obtain input from stakeholders on considerations for development and submission of proposed draft guidance relating to patient …

Cybersecurity | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity
    The U.S. Food and Drug Administration (FDA) is informing laboratory personnel and health care providers about a cybersecurity vulnerability affecting software in the …

Public Workshop - Medical Extended Reality: Toward …

    https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-workshop-medical-extended-reality-toward-best-evaluation-practices-virtual-and-augmented
    Apr 13, 2020



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