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  1. www.fda.gov › medical-devices › how-study-and-market-your-deviceBreakthrough Devices Program | FDA

    The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket...

  2. www.fda.gov › search-fda-guidance-documents › breakthrough-devices-programBreakthrough Devices Program | FDA

    14 de sept. de 2023 · The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of...

  3. www.fda.gov › cdrh-issues-updated-final-guidance-breakthrough-devices-programUpdated Final Guidance on Breakthrough Devices Program

    14 de sept. de 2023 · The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of...

  4. www.nature.com › articles › s41587/020/0636-7Early experience with the FDA’s Breakthrough Devices program

    23 de jul. de 2020 · We sought to examine five key aspects of early FDA experience with the BDP: first, the number of devices receiving FDA breakthrough designation over time; second, characteristics of devices...

  5. www.statnews.com › 2022/08/11 › fda-authorization-breakthrough-medical-devicesThe FDA’s ‘breakthrough’ medical devices are finally ... - STAT

    11 de ago. de 2022 · T he Breakthrough Device Program is approaching terminal velocity. The Food and Drug Administration, looking to accelerate access to innovative devices, has now labeled nearly 700 products as...

  6. www.nature.com › articles › s41587/023/01746-3Challenges and solutions to advancing health equity with medical...

    10 de abr. de 2023 · In this Correspondence, we examine core equity considerations for medical device regulation and apply these insights to the proposed FDA reforms for breakthrough-designated medical devices.

  7. array.aami.org › content › newsFDA Updates Final Guidance for Breakthrough Devices Program

    14 de sept. de 2023 · According to the agency, the 2023 update to the final guidance, Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff, clarifies: How the Breakthrough Devices Program may apply to certain medical devices that promote health equity.