Litigation between companies in the med-tech space often revolves around patents, but the ongoing series of lawsuits between Philips Respironics Inc. and Soclean Inc. are directed toward the interaction between CPAP machines and CPAP cleaning systems.

The U.S. FDA caught up with four makers of CPAP cleaning machines in the form of warning letters advising the manufacturers that the claims made for their systems fall under the definition of a regulated medical device. In two of these warning letters, the FDA said it had been in touch with the manufacturer for at least two years, indicating that the agency has been steadily working on enforcement activities in this space for some time.

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.