FDA Medical Devices

Official FDA - device recalls, safety, authorizations, radiation-emitting products. Contact us [email protected] or 800-638-2041

[FDA Medical Devices @FDADevices]

Big update coming to our X account! Starting Aug. 7th, we'll be @FDADevices. Followers don't need to do a thing! You'll continue following us automatically. Same medical device safety information, fresh handle.

[FDA Medical Devices @FDADevices]

https://t.co/GYf6eDZy4g

[FDA Medical Devices @FDADevices]

The FDA is announcing a meeting on Sept. 23 of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee) to discuss GRAIL Inc.’s Galleri® test premarket approval application.

[FDA Medical Devices @FDADevices]

The Galleri® test is a prescription-only blood test intended for screening for the early detection of multiple types of cancer in adults aged 50 years or older. The FDA is establishing a docket for public comment. For more details and to learn how to submit written comments:

[FDA Medical Devices @FDADevices]

@US_FDA is bringing together stakeholders for "Regulatory Science Innovations Catalyzing Medical Device Development."

Be part of the discussion that's shaping tomorrow's regulatory landscape. Find out more: https://t.co/MabLnmzpRb

[FDA Medical Devices @FDADevices]

One more day! Tomorrow we make the switch to @FDADevices on X. Current followers don't need to do a thing to your… devices. You'll continue following us without any changes.

[U.S. FDA @US_FDA]

Use FDA Form 5072 to ensure your medical device recall submission is complete.

FDA is encouraging device manufacturers to consider using FDA Form 5072, “Device Correction and Removal Report,“ when submitting required information for voluntary recalls.   

https://t.co/9Aa4vmCCMX

[U.S. FDA @US_FDA]

Medical Device Manufacturers. Refer to this list of useful information prior to submitting recall information. Here you will find Form 5072 and FAQs specific to medical device recalls.

Using Form 5072 helps ensure your medical device recall submission includes everything FDA needs — promoting efficiency in the recall initiation process.

https://t.co/HZ0ZI9m1Rw

[U.S. FDA @US_FDA]

Have a device correction or removal? Not sure what’s required when reporting?

FDA’s Medical Device Recalls FAQ covers Part 7 and Part 806 requirements – from what triggers a report to what info must be included.

 https://t.co/et1yoboDt2

[FDA Medical Devices @FDADevices]

News: The FDA requests input on certain non-device software functions and impacts to patient safety by Aug. 13, 2026. This input will help the FDA develop the 2026 report on the risks and benefits to health of non-device software functions. Learn more: https://t.co/1CiZ3lPQEH

[FDA Medical Devices @FDADevices]

The FDA remains committed to taking appropriate actions to address ongoing data integrity concerns.

[FDA Medical Devices @FDADevices]

Update: The FDA continues to observe unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors.
https://t.co/jzFhSCkIv5

[FDA Medical Devices @FDADevices]

We have determined that CCIC Huatongwei International Inspection (Suzhou) Co., Ltd. has, in several instances, copied results from other studies or generated falsified and otherwise invalid data submitted to the FDA.

[FDA Medical Devices @FDADevices]

The goal of the Innovation Challenge, which is part of the FDA’s Home as a Health Care Hub Initiative, is to accelerate patient access to medical device technologies aimed at reducing hospital readmission.
https://t.co/SuTnOi8nTO

[FDA Medical Devices @FDADevices]

The FDA is publishing a new FAQ page for innovators interested in the READI-Home Innovation Challenge.

[FDA Medical Devices @FDADevices]

RT @US_FDA: If you have, or are considering purchasing, a SNOO Smart Sleeper, please be aware that the manufacturer has been selling new sl…

[FDA Medical Devices @FDADevices]

The FDA is exempting certain low-risk unclassified medical devices from premarket notification requirements. These devices are appropriate for Class I/II classification & don't need 510(k) review to ensure safety. Less burden, same safety standards. https://t.co/9RQ3FIIOCH

[FDA Medical Devices @FDADevices]

Today, we celebrate Fifty Years of the Medical Device Amendments and the incredible work of CDRH. Here's to the next 50!
https://t.co/8IlV8w8wQY

[FDA Medical Devices @FDADevices]

50 years ago today, the Medical Device Amendments were signed into law — giving @US_FDA authority to ensure the safety & effectiveness of medical devices.

[FDA Medical Devices @FDADevices]

This marketing authorization is part of the FDA’s ongoing commitment to delivering innovative solutions that support improvements in patient outcomes.

[FDA Medical Devices @FDADevices]

The FDA authorized marketing of the DeepView AI System to detect deep burn tissue and flag specific skin areas unlikely to heal within 21 days. The DeepView AI System utilizes hardware and AI-driven software to analyze images obtained from the burn. https://t.co/p5rnK9NDWd

[FDA Medical Devices @FDADevices]

It is intended for prescription use by healthcare providers in conjunction with clinical assessment and not as a stand-alone diagnostic device.