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.
In responses to two Republican senators, Robert Califf — the Biden administration’s nominee for FDA commissioner — provided a deeper look into the priorities he would set at the helm of the agency if confirmed to the top post once again. Read More
In its continuing effort to hire highly skilled senior executives from the private sector, the FDA took advantage of provisions in the 21st Century Cures Act to offer higher salaries than it could under traditional federal hiring authorities, but it still needs an overall workforce strategy for drugs and devices, the Government Accountability Office (GAO) said in a new report. Read More
Apple’s electrocardiograph (ECG) software for over-the-counter use, available as an app, has received a risk downgrade from the FDA to class II (special controls) as opposed to the highest-risk class III category. Read More
The FDA has failed to send Congress a required commitment letter for reauthorization of the Medical Device User Fee Act (MDUFA) by the Jan. 15 deadline. Read More
Companies located outside the European Union (EU) need to designate an EU-authorized representative if they want to sell SARS-CoV-2 in vitro diagnostic devices in EU countries, the EU’s Medical Device Coordination Group (MDCG) has advised. Read More
The number of EU Notified Bodies empowered to certify devices for a CE mark or CE-in vitro diagnostic (IVD) mark has increased by two, to 27. Read More
The FDA has outlined its latest thinking in a draft guidance on how companies should report manufacturing or supply issues that might reduce or eliminate the availability of critical equipment during a public health emergency. Read More
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new advice to device manufacturers on how to register their products now that the country no longer relies on the EU’s CE mark. Read More
Anita Jackson, a physician in Raleigh, N.C., was indicted by a federal grand jury on Wednesday for allegedly adulterating medical devices for reuse on patients and other related charges. Read More