The European Association for Medical Devices of Notified Bodies has issued its survey of member NBs for 2023, which includes data that suggest a diminishing appetite for inspections under the Medical Device Single Audit Program. However, the more concerning metric is that the gap between applications for new or renewed medical devices and the number of completed applications continues to widen, a gap that stood at nearly 10,000 such applications at the end of calendar year 2023.

The U.S. FDA’s reissued draft guidance for pre-submission activity addresses the circumstances in which a manufacturer’s questions can be handled informally, but industry has a few misgivings about the draft. One of these is that a preformatted template proposed by the FDA would limit the number of topics that can be handled in an informal manner, which the Advanced Medical Technology Association said might drive more utilization of formal pre-submission programs, an outcome that would thwart the intent of these informal interactions.

A recent hearing in the U.S. House of Representatives highlighted some of the issues Congress has with the agency’s performance, but there were questions as well about the FDA’s statutory authorities. One of these is the lack of statutory authority to require a recall for prescription drugs as well as the deadline for notifying the agency of device recalls, both of which are areas of legislative interest on the part of Congress.

Vyaire Medical Inc., of Mettawa, Ill., reported a class I recall of its Twin Tubes devices, which are used in the collection of air samples during cardiopulmonary exercise testing. The recall was prompted by the risk that the device nozzle will separate during patient use and potentially result in choking, although the FDA said there have been no reports of adverse events in connection with the problem.

The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance regarding adenoma, the advisory committee voted 6-3 that the benefits outweigh the risks in a decision the FDA is likely to affirm.

The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance with regard to adenoma, the advisory committee voted 7-2 that the benefits outweigh the risks in a decision the FDA is likely to affirm.

The U.K. Medicines and Health Care Products Regulatory Agency is considering a policy of mutual recognition of medical devices that have won marketing authorization in four other jurisdictions, including the U.S. and the EU. While there are significant exclusions – such as for some articles that qualify as software as a medical device – this policy would be in force at some point in 2025, easing the path forward for products in a market that is home to nearly 67 million potential patients.

Abbott Laboratories announced a class I recall of the Heartmate 3 left ventricular assist system (LVAS) that affects nearly 890 units distributed over the past three years, a move triggered by reports of blood leakage or air entry into the device during implant procedures.

The European Council (EC) voted to approve the Artificial Intelligence Act (AI Act), a sweeping horizontal legislative product that affects all sectors of the European Union’s (EU) economy. Regulatory attorney Erik Vollebregt told BioWorld that the horizontal nature of the AI Act is still likely to exacerbate some of the problems already seen with the Medical Device Regulation (MDR) in a way that he said will make the EU market less attractive than is already the case.

The Cleveland Clinic Foundation (CCF) has found itself on the wrong end of an enforcement action by a federal attorney’s office, which had alleged that CCF had made false statements to the government regarding three grant awards.