In its 2021 annual report, the US FDA’s Center for Devices and Radiological Health outlines what it sees as list of accomplishments in a year director Jeff Shuren says was perhaps the busiest in the center’s history.
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) released its 2021 annual report highlighting several emergency use authorizations (EUAs) in “record time” for a variety of devices to address public health needs during the COVID-19 pandemic.
In the report, released 31 January, CDRH director Jeff Shuren says one way the center is tracking its success is...
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
