The U.S. FDA’s authority was challenged on a number of occasions over the past few decades, but the rate is likely to pick up as the U.S. Supreme Court ruled recently that the agency cannot take judicial deference for granted any longer. Chad Landmon of the D.C. office of Polsinelli told BioWorld that future litigation against the FDA may extend even to sub-regulatory guidance thanks to the outcome in the case of Loper Bright – a scenario in which industry might carve out a few significant wins in the coming year.

The U.S. FDA’s emphasis on alternatives to ethylene oxide is gaining momentum with the help of internationally recognized standards — such as ISO 11737 — in a move that will enable a less cumbersome approach to non-EtO device sterilization.

The fact that both the U.S. Federal Trade Commission and the Department of Justice have oversight of mergers and acquisitions is something of a regulatory oddity. But David Balto, an attorney specializing on antitrust matters, told BioWorld that this may change in 2025 thanks to support for such a move from both Congress and the White House.

Administrators at the U.S. Medicare program have proposed to cover the Cardiomems remote monitoring device for heart failure, but cardiologists are averse to several of the conditions spelled out in the draft coverage memo, including what they see as a somewhat futile demand for a comparator arm in the proposed coverage study.

Third-party patent litigation funding has been a concern for device makers for some time, but a recent report by the U.S. Government Accountability Office indicates that the Department of Justice is looking into the practice for evidence that foreign entities are involved in patent litigation funding.

The COVID-19 pandemic reset expectations of Medicare telehealth coverage, prompting a letter from dozens of members of Congress to Capitol Hill leadership asking for legislation that will memorialize telehealth benefits. But concerns over spending, fraud and abuse still hang over the discussion.

The FDA’s final guidance for predetermined change control plans (PCCPs) for AI products contains a number of editorial changes, some more significant than others.

Medicare coverage of FDA-designated breakthrough devices is still a policy hot topic. Although the House of Representatives generated some momentum on related legislation, the Senate is now examining the Ensuring Patient Access to Critical Breakthrough Products Act for potential passage in the lame duck session – a development that would draw enthusiastic cheers from industry.

The FDA’s August 2024 draft guidance for predetermined change control plans (PCCPs) for all device types has provoked some misgivings among industry, with both the Medical Device Manufacturers Association and the Advanced Medical Technology Association blasting the draft’s limitations on the scope of the changes that could be included in a PCCP.

The FDA announced a new pilot program for communication of medical device recalls, but industry may be wary of a program that seems to be driven toward early notification of what the agency believes “are likely to be high-risk recalls.” The agency’s device center states that this latest effort is designed to “improve the timeliness of communications” of corrective actions undertaken by device manufacturers. This would apply when the corrective action is as significant as a device removal and when the corrective action constitutes nothing more than an update to a product’s instructions for use.