Device makers doing business in the U.S. have had a much more stable regulatory regime than has been true for companies in other jurisdictions, but that will shift somewhat in 2025. Brynn Stanley of Gardner Law told BioWorld that manufacturers should get busy with the U.S. FDA-mandated do-over of their quality management systems as the compliance deadline of February 2026 does not generally permit procrastination.

The U.S. FDA’s newest draft guidance for dealing with medical product misinformation might seem to signal a cooperative attitude toward misinformation on the agency’s part, but regulatory attorney Daniel Kracov told BioWorld that the disincentives for doing so might still outweigh the incentives despite the reworked draft guidance.

The U.S. FDA posted another early advisory, this time for the Mini PCNL devices by Trokamed GmbH. The agency noted that these devices should not be used for suction and irrigation of surgical sites, a use for which the device was not cleared in the first place.

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.