FDA Guides Return to Pre-Pandemic Medical Device Enforcement, EUA Policies
The FDA finalized guidance that outlines recommendations regarding the transition of medical device enforcement policies to normal operations
The FDA finalized guidance that outlines recommendations regarding the transition of medical device enforcement policies to normal operations
Philips recalled certain bi-level positive airway pressure machines that may contain a plastic contaminated with a non-compatible material.
The FDA is holding a meeting to discuss the reauthorization of the Medical Device User Fee Amendments for fiscal years 2023 through 2027. Â
The FDA finalized guidance that outlines recommendations regarding the transition of medical device enforcement policies to normal operations
Robert M. Callif was narrowly confirmed as the next commissioner of the FDA following divisive voting in the senate. Califf previously led the FDA in 2016.
Read MoreThe FDA says the feeding set tubing can become wrapped around a child’s neck and cause strangulation or death.
Read MoreThe U.S. FDA’s first medical device cyber chief Kevin Fu shares with MedTech Dive his take on medical device cybersecurity and how the agency’s regulatory policy can help improve it.
Read MoreMedtronic has received U.S. FDA approval for Vanta, a high-performance recharge-free implantable neurostimulator with a device life that can be optimized up to 11 years.
Read MoreThe FDA had previously issued EUAs for decontamination systems to sterilize masks up to 10 times to combat shortages, but with its reissued EUAs the agency now says 4 times should be the max.
Read MoreThe FDA added new supplies, including gloves and ventilators, to its medical device shortage list, as well as more information about the products.
Read MoreThe U.S. FDA has released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan. This action plan describes a multi-pronged approach to advance the agency’s oversight of AI/ML-based medical software.