The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the rub for some stakeholders. The Advanced Medical Technology Association pressed the agency to ensure that the final guidance takes into account the hazards of electronic access during remote BiMo audits, but the final guidance makes no such concessions.
Every year seems to introduce novel approaches to litigation when it comes to product liability and other theories of harm from medical devices, and 2025 was no exception. One of the more interesting cases was CLF 007 v. Cooper Surgical, which broke new ground for its handling of non-existent state legal precedent.
The new U.S. FDA leadership has broken with standing agency practice in several areas and in the latest move seeks to cut out the middleman in FDA contracting practices, a development that might aid small firms that are financed by venture capital.
The U.S. Centers for Medicare & Medicaid Services announced that several Medicare administrative contractors have formally withdrawn local coverage determinations for skin substitutes. There are questions, however, as to whether this will bring an end to excess spending on these products even though the agency has capped the rate paid for entire classes of products.
The U.S. Office of the National Coordinator has proposed to significantly whittle back the regulations pertaining to electronic health records, changes that would save small businesses significant sums in terms of compliance activities.
The U.S. FDA’s final rule for regulation of lab-developed tests was destined to be controversial at best and exceptionally susceptible to legal challenge according to more than one legal opinion. The inevitable legal challenge succeeded wildly in a decision rendered in district court in March 2025, marking one of the rare instances in which the courts thwarted FDA rulemaking and thus is easily the regulatory story of the year for 2025. Attempts to regulate AI in the U.S. and Europe also dominated the regulatory landscape.
The EU’s Medical Device Coordination Group (MDCG) posted two guidances in the waning weeks of 2025, one of which deals with postmarket surveillance for both devices and diagnostics. Another guidance deals with breakthrough devices (BtX) and diagnostics, a question that is not well described in either of the current EU regulatory frameworks.
Payers had their hands full in 2025 dealing with the raft of medical technologies that came through the globe’s regulatory review processes, although the nature of many of those challenges were conventional. On the other hand, payers struggled to keep pace with both the volume of conventional devices and the novelty of AI-driven devices in 2025, a problem that will carry over into the coming year.
The U.S. Securities and Exchange Commission announced Dec. 23 that Bryan Scott McMillen has agreed to pay a total of more than $140,000 due to allegations of insider trading in connection with Boston Scientific Corp.’s acquisition of Apollo Endosurgery Inc. The failure of federal authorities to prosecute McMillan under the criminal code may be a reflection of the relatively small sums he had illicitly obtained in the transaction. A Department of Justice investigation resulted in a conviction for $1 billion in health care fraud.
The year 2025 will go down in med-tech history as remarkable for a number of things, but manufacturers doing business in the EU might be forgiven for thinking that it was a year for correction of self-inflicted wounds, even if those corrections won’t arrive in full form until 2026.
