FDA Medical Devices
@FDADeviceInfo
Followers
98K
Following
791
Media
2K
Statuses
9K
Official FDA - device recalls, safety, approvals, radiation-emitting products. Contact us [email protected] or 800-638-2041 https://t.co/hfXZUjyrJx
Silver Spring, Maryland, USA
Joined May 2010
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:
0
0
0
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: https://t.co/GzYFxyNyGm
1
2
0
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. https://t.co/5QQS8EjGBb
9
15
24
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. https://t.co/nD6tsOwm9c
15
27
52
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:
0
2
0
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: https://t.co/GzYFxyNyGm
2
8
9
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. https://t.co/YZkrFYssC6
5
13
16
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. https://t.co/Ong567XWN7
2
9
5
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. https://t.co/XKtPG5SGUe
19
22
36
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: https://t.co/MEJO3o0Al4
6
11
24
The @US_FDA has added pediatric ventricular assist bypass devices (product code DSQ) to the Medical Device Shortages List. Find out more: https://t.co/zPf8QJHSrf
0
9
3
Attention medical device manufacturers: Starting Oct. 1, all De Novo submissions must use eSTAR. Don't delay – prepare now! Learn more: https://t.co/KqF0mZ56DL
#FDAeSTAR #MedicalDevices
0
7
3
The FDA has updated its list of medical devices that incorporate augmented reality and virtual reality (AR/VR). https://t.co/7Ko9RfvinZ This list is a resource intended to identify AR/VR medical devices that are authorized for marketing in the U.S.
2
12
17
Access the FDA’s new list of medical devices incorporating sensor-based digital health technology (sDHT)! https://t.co/5E5m30wgFo The sDHT medical device list is a resource intended to identify those devices that are authorized for marketing in the U.S.
1
8
14
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: https://t.co/7Ko9RfvinZ
1
7
4
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. https://t.co/Ong567XWN7
1
10
2
Sponsors of device studies and manufacturers of devices are reminded to carefully evaluate the third parties they engage to conduct safety, performance, and cybersecurity testing and to independently verify all testing results before submitting to the FDA.
0
10
2
Until the firm adequately addresses these issues, all study data from all studies conducted at this testing facility will be rejected.
2
8
0
We have determined that Sanitation & Environment Technology Institute of Soochow University dba SDWH has, in several instances, copied the results of another study or created falsified or otherwise invalid data that was submitted to FDA.
2
0
1
The FDA has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors.
8
7
2