The U.S. FDA has received a citizen petition to grant over-the-counter status to continuous positive airway pressure (CPAP) machines, an oddly timed petition given a recent enforcement action against one of the prime movers in the CPAP space.

New York-based Cleerly Labs Inc., petitioned several U.S. Medicare administrative contractors for coverage of the use of the company’s artificial intelligence product for analysis of CT coronary arteries to evaluate the disease burden of plaque.

The Parliament of the U.K. has dissolved right on schedule, leaving the members of the House of Commons with a raft of policy issues to deal with in the next assembly. One of these issues is a bill originating in the House of Lords, the Artificial Intelligence Bill, which seems technologically agnostic and thus may represent a risk of duplicative oversight of AI for health care purposes.

The U.S. Department of Justice announced May 29 that Innovasis Inc., of Salt Lake City and two of the company’s executives have agreed to pay $12 million over allegations of payment of kickbacks to surgeons.

The European Council formally approved another delay for the In Vitro Diagnostic Regulation implementation, which now gives developers of existing high-risk in vitro diagnostics until December 2027 to obtain a renewed CE mark.

The problem of counterfeit devices has perplexed the U.S. FDA for some time, given that the agency had previously been forced to send the illicit products back to the originator, only to see the same devices reenter the U.S.

The American Clinical Laboratory Association has followed through on its promise to file suit against the U.S. FDA over the agency’s final rule for lab-developed tests. The lawsuit will be heard in the U.S. District Court for the Eastern District of Texas, which is also the venue for litigation against another federal government agency, the Federal Trade Commission, suggesting that litigants expect a favorable review of their case in this court.

The European Association for Medical Devices of Notified Bodies has issued its survey of member NBs for 2023, which includes data that suggest a diminishing appetite for inspections under the Medical Device Single Audit Program. However, the more concerning metric is that the gap between applications for new or renewed medical devices and the number of completed applications continues to widen, a gap that stood at nearly 10,000 such applications at the end of calendar year 2023.

The U.S. FDA’s reissued draft guidance for pre-submission activity addresses the circumstances in which a manufacturer’s questions can be handled informally, but industry has a few misgivings about the draft. One of these is that a preformatted template proposed by the FDA would limit the number of topics that can be handled in an informal manner, which the Advanced Medical Technology Association said might drive more utilization of formal pre-submission programs, an outcome that would thwart the intent of these informal interactions.

A recent hearing in the U.S. House of Representatives highlighted some of the issues Congress has with the agency’s performance, but there were questions as well about the FDA’s statutory authorities. One of these is the lack of statutory authority to require a recall for prescription drugs as well as the deadline for notifying the agency of device recalls, both of which are areas of legislative interest on the part of Congress.