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.
Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention. Read More
Industry representatives have endorsed measures that would streamline the FDA’s premarket review process, but said they will be watching closely for tangible results in exchange for a $320 million increase in user fees. 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
The FDA is taking steps to address cybersecurity vulnerabilities in medical devices but needs to foster more cooperation between stakeholders to encourage timely reporting of cybersecurity incidents, Rep. Diana DeGette (D-Colo.) said in an interview. Read More
The FDA has announced that it will not release final guidance on laboratory developed tests (LDTs), and instead will work with Congress and other stakeholders to determine how LDTs… Read More