FDA Medical Devices

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FDA Medical Devices

FDA Medical Devices

@FDADeviceInfo

Official FDA - device recalls, safety, authorizations, radiation-emitting products. Contact us [email protected] or 800-638-2041 https://t.co/hfXZUjyZz5

Silver Spring, Maryland, USA Katılım Mayıs 2010
405 Takip Edilen97.2K Takipçiler
FDA Medical Devices retweetledi
U.S. FDA
U.S. FDA@US_FDA·
Today, FDA issued final guidance for medical devices with indications for use associated with weight loss as part of the FDA’s ongoing efforts to support the development of safe and effective medical devices that can improve health outcomes and reduce the burden of chronic disease in the U.S. fda.gov/regulatory-inf…
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U.S. FDA
U.S. FDA@US_FDA·
The FDA approved a first-of-its-kind device to treat locally advanced pancreatic cancer, reflecting the agency’s unwavering commitment to advancing safe and effective medical devices that address chronic diseases and improve the lives of Americans. fda.gov/news-events/pr…
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FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
Anchored on the pillars of safety & innovation, the CDRH 2025 annual report highlights the Center’s resilience and sustained performance this past year. Check out CDRH’s 2025 Annual Report to learn more about their work to protect & promote public health: fda.gov/media/190779/d…
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U.S. FDA
U.S. FDA@US_FDA·
Today, the FDA announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a first-of-its-kind digital health pilot to expand access to chronic disease technologies. fda.gov/news-events/pr…   The voluntary pilot is designed to promote access to certain digital health devices while safeguarding patient safety and marks a major step in the agency’s plan to support technology-enabled care, strengthen chronic disease management, and expand health care access for patients nationwide.
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FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
Reminder: submit written comments on generative AI-enabled digital mental health medical devices to docket number FDA-2025-N-2338 by Dec. 8 for review and consideration by the FDA. fda.gov/advisory-commi…
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FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
The FDA Digital Health Advisory Committee will discuss generative AI-enabled digital mental health medical devices at its Nov. 6 virtual meeting. Learn how to submit written public comments on the meeting: regulations.gov/document/FDA-2…
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FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
The FDA has posted materials for the virtual Digital Health Advisory Committee meeting on Nov. 6. Access the meeting materials and webcast link, and learn more about the meeting: fda.gov/advisory-commi…
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FDA Medical Devices retweetledi
U.S. FDA
U.S. FDA@US_FDA·
The FDA announced a request for public comment by Dec. 1 on measuring and evaluating the performance of AI-enabled medical devices in the real-world. fda.gov/medical-device…
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FDA Medical Devices retweetledi
U.S. FDA
U.S. FDA@US_FDA·
Today, we authorized the marketing of the first eyeglass lenses to slow the progression of nearsightedness in children 6 to 12 years old at the initiation of treatment. fda.gov/news-events/pr…
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FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
We’re also establishing a docket for public comment for the scheduled Nov. 6 virtual Digital Health Advisory Committee meeting. Learn how to submit written comments: Regulations.gov
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FDA Medical Devices@FDADeviceInfo·
The FDA is scheduled to host a virtual Digital Health Advisory Committee meeting Nov. 6 to discuss generative AI-enabled digital mental health medical devices. Learn more: fda.gov/advisory-commi…
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FDA Medical Devices@FDADeviceInfo·
While some per- & polyfluoroalkyl substances (PFAS) chemicals are linked to health concerns, the materials used in medical devices are not the same. FDA’s evaluation is currently there is no reason to consider restricting their continued use in devices. fda.gov/medical-device…
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FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
Reminder: Monday, August 4, the @US_FDA will host a public meeting to discuss recommendations for the reauthorization of the Medical Device User Fee Amendments for fiscal years 2028 through 2032 (MDUFA VI). Find out more and register today. fda.gov/medical-device…
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U.S. FDA
U.S. FDA@US_FDA·
The FDA is releasing the Regulatory Accelerator, a set of resources that support FDA’s priority to accelerate cures and treatments by helping digital health innovators bring safe and effective medical devices to market. fda.gov/medical-device…
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U.S. FDA
U.S. FDA@US_FDA·
The FDA is announcing a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee). For more information, please visit: fda.gov/advisory-commi…
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FDA Medical Devices
FDA Medical Devices@FDADeviceInfo·
The FDA has updated its list of medical devices that incorporate augmented reality and virtual reality (AR/VR). #list" target="_blank" rel="nofollow noopener">fda.gov/medical-device… This list is a resource intended to identify AR/VR medical devices that are authorized for marketing in the U.S.
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FDA Medical Devices@FDADeviceInfo·
Access the FDA’s new list of medical devices incorporating sensor-based digital health technology (sDHT)! fda.gov/medical-device… The sDHT medical device list is a resource intended to identify those devices that are authorized for marketing in the U.S.
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FDA Medical Devices@FDADeviceInfo·
The FDA has updated its list of medical devices that incorporate augmented reality and virtual reality (AR/VR). This list is a resource intended to identify AR/VR medical devices that are authorized for marketing in the U.S. Access the list: #list" target="_blank" rel="nofollow noopener">fda.gov/medical-device…
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