We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Janet Woodcock, principal deputy FDA commissioner, made clear the dire situation her agency will be in if user fees aren’t rapidly reauthorized and the FDA doesn’t receive new money from Congress to update its flagging IT infrastructure. Read More
As the EU’s 2017 Medical Device Regulation (MDR) comes fully into force, devicemakers need to keep track of significant changes in the form of “implementing and delegated acts,” according to one UK-based regulatory expert. Read More
Smiths Medical has issued an urgent medical device correction letter about a potential risk associated with pressure chambers used with the company’s Level 1 Fast Flow Fluid Warmers, which deliver solutions or warmed blood to patients. Read More
The Center for Devices and Radiological Health (CDRH) is seeking companies involved in medical device development and manufacturing to participate in its Experiential Learning Program (ELP), which sends CDRH staff on virtual or on-site training visits. Read More
Lice Clinics of America says its medical device is the only product on the market that has been cleared by the FDA to use air in treating head lice. Read More