Michelle Tarver, the new director of the FDA’s medical device division, has expressed concerns that the U.S. may lag behind other countries in safeguarding patient care due to limited mandatory reporting on medical device shortages. Highlighting a recent European regulation that provides essential information on device shortages, Tarver criticized the U.S. reliance on voluntary notifications, which often leaves healthcare providers uninformed until shortages impact patient care. She called for new statutory authority to mandate device shortage reports and full funding for the FDA’s supply chain program to improve patient safety.

Source: https://www.supplychaindive.com/news/tarver-medical-device-supply-chain-vulnerabilities/737719/