As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, less attention has been given to the new administration ...
FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
Because AI is so new, a lot of the FDA employees working ... of 40 working on reviewing imaging devices, as well as 40 people on a research team that helps regulatory staff understand AI and ...
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
If confirmed, Makary would run one of the nation's leading health agencies, overseeing the regulation of food and drugs.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback