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Pharmaceutical and medical device companies should not be held liable for terrorist actions after providing medical products to the Iraqi government, says an amicus brief from the U.S. Chamber of Commerce and PhRMA filed to the U.S. Supreme Court. Read More
The company says customers should return any inventory that is not implanted and report any adverse reactions or quality problems to Abbott or the FDA. Read More
Only 28 out of 64 medical device and diagnostic technologies, or 44 percent, requiring new Medicare coverage received reimbursement from 2016 to 2019, with the median time to at least nominal coverage taking 5.7 years, according to Stanford University researchers. Read More
CDRH is accepting and holding in-person meetings with stakeholders and also offering hybrid in-person and virtual – meeting options, Director Jeff Shuren said in a statement Wednesday updating the industry on its return to post-COVID normalcy. Read More
Quidel Cardiovascular’s recall of Quidel Triage Cardiac Panels, used to diagnose a heart attack, has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death. Read More
The FDA is accepting proposals to host in-person or remote visits to allow CDRH staff the opportunity to gain real-world knowledge through the CDRH Experiential Learning Program (ELP). Read More
Abbott announced that it is withdrawing all of its Trifecta heart valves from the U.S. market and removing the remaining inventory from the field due to early structural valve deterioration (SVD). Read More
Improving FDA advisory committee procedures and combatting misinformation are two important goals for FDA’s Chief Scientist Namandjé N. Bumpus who shared some insights from her first year of work during an informational “fireside chat” sponsored by the Alliance for a Stronger FDA on Wednesday. Read More
Comments from numerous stakeholders have sounded the alarm over the lack of detail on oversight/responsibility for remote vendors and a new“task log” in the FDA’s draft guidance on decentralized trials (DCT). Read More