The U.S. FDA’s October 2025 draft guidance for quality management system information in premarket filings may have struck some observers as an example of regulatory overreach, given the robust opposition to several key aspects of the draft on the parts of the Advanced Medical Technology Association and the Medical Device Manufacturers Association.
A committee of the House of Representatives advanced a bill that if passed will give eligible breakthrough medical devices four years of Medicare coverage.
The draft Medicare physician fee schedule (MPFS) for 2026 proposed to treat skin substitutes as incident-to supplies in the related procedures, but the blowback was pronounced and vigorous, with London-based Convatec plc arguing that the agency lacks the statutory authority to make such a change.
Eleven pages is relatively short for a modern U.S. FDA draft guidance, but two trade associations nonetheless had questions about the FDA draft for transfers of 510(k) devices, such as how the agency defines the holder of the 510(k).
Australia’s largest health insurance company, Medibank Private Ltd., is the first to reimburse for psychedelic treatment in Australia, funding Emyria Ltd.’s MDMA (3,4-methylenedioxy-methamphetamine) program for post-traumatic stress disorder offered through the Perth Clinic.
The U.S. FDA finalized the latest edition of its premarket cybersecurity guidance, but the agency is of the view that any device with software is subject to the terms of the guidance even though the statute would seem to exempt device software that lacks connectivity.
Australia’s largest health insurance company, Medibank Private Ltd., is the first to reimburse for psychedelic treatment in Australia, funding Emyria Ltd.’s MDMA (3,4-methylenedioxy-methamphetamine) program for post-traumatic stress disorder offered through the Perth Clinic.
Physicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight.
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), covered several programmatic areas in a May 1 trade association meeting, such as the CDRH early alert program.
The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.
