FDA Medical Devices @FDADeviceInfo

Official FDA - device recalls, safety, approvals, radiation-emitting products. Contact us [email protected] or 800-638-2041 https://t.co/hfXZUjyrJx fda.gov/medical-device… Silver Spring, Maryland, USA Joined May 2010

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FDA Medical Devices @FDADeviceInfo

4 weeks ago

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 @FDADeviceInfo

a month ago

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 @US_FDA

a month ago

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 @US_FDA

a month ago

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 @FDADeviceInfo

2 months ago

The @US_FDA has added pediatric ventricular assist bypass devices (product code DSQ) to the Medical Device Shortages List. Find out more: fda.gov/medical-device…

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FDA Medical Devices @FDADeviceInfo

2 months ago

Attention medical device manufacturers: Starting Oct. 1, all De Novo submissions must use eSTAR. Don't delay – prepare now! Learn more: fda.gov/regulatory-inf… #FDAeSTAR #MedicalDevices

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FDA Medical Devices @FDADeviceInfo

2 months ago

The FDA has updated its list of medical devices that incorporate augmented reality and virtual reality (AR/VR). 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

2 months ago

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

2 months ago

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: fda.gov/medical-device…

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FDA Medical Devices @FDADeviceInfo

3 months ago

On 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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FDA Medical Devices @FDADeviceInfo

5 months ago

“Do you have questions about reporting requirements for medical device convenience kit manufacturers? Visit our new FAQ page titled Convenience Kit Reporting Requirements for Corrections, Removals, and Recalls, to learn about your responsibilities.” fda.gov/safety/recalls…

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FDA Medical Devices @FDADeviceInfo

5 months ago

FDA has identified Medtronic’s removal of certain Aortic Root Cannulas due to unexpected loose material that occurred during the manufacturing process as a Class I recall, the most serious type of recall. Find out more: fda.gov/medical-device…