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.
The International Medical Device Regulators Forum has developed guidance outlining the steps required to generate clinical evidence of effectiveness and safety of software as a medical device (SaMD). Read More
Medicare spent $1.5 billion and patients spent $140 million as a result of just seven recalled or failed cardiac devices, spending that could be better controlled if unique device identifiers (UDIs) were required on CMS claim forms, according to a report by the HHS Office of Inspector General (OIG). Read More
Medical device manufacturers have yet another database to worry about, since the FDA launched a website where anyone can file a complaint that a medical device is violating agency rules. Read More
The FDA’s unique device identification (UDI) rule might improve device tracking but is plagued with unresolved issues such as how to label devices with multiple components. Read More
Sweeping new medical device regulations in the European Union are expected to be finalized in December or early 2017, although medical device manufacturers will still have three to five years to comply. Read More