Sen. Amy Klobuchar (D-Minn.) spoke to an industry meeting in Washington and expressed concerns about the situation at the U.S. FDA, but she also blasted the tariffs put in place by the Trump administration as lacking the proper statutory authority.
The U.S. Securities and Exchange Commission said it obtained a judgment for a total of $17 million in penalties and disgorgement from a group of individuals and entities charged with investor fraud.
The Trump administration’s tariff activities provoked another set of responses from both Medtech Europe and the Advanced Medical Technology Association.
The U.S. Centers for Medicare & Medicaid Services will hold an advisory meeting regarding devices for treatment of symptoms for Parkinson’s disease, but the agency indicated that it expects to see longer-term data for these treatments if manufacturers want Medicare coverage.
The U.S. Department of Justice recently announced the formation of a task force that will advocate the roll-back of regulations that affect a wide swath of sectors of the American economy. Health care is one of the areas of interest for the task force, which will examine state as well as federal regulations.
The U.S. FDA’s authority to require cybersecurity measures in premarket submissions is a radical change for industry, but firms must document that they have erected solid cybersecurity measures.
Staffing cuts at the FDA’s device center led to speculation that the current user fee program may be fatally damaged, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said in a meeting in Columbus, Ohio that there are too many resources for FDA at stake for the user fee program to be ended.
The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.
The European Association of Medical Device Notified Bodies inked a position paper on the EU Artificial Intelligence Act which recites some standing concerns. Perhaps the most interesting passage in the paper is that there is a need for a “well-coordinated approach between member states that are in charge of notified body oversight.”
