The FDA recommends knocking hemodialysis access devices from Class III to Class II devices, making them subject to less-stringent review requirements.
The FDA recommended bumping blood access devices down from Class III to Class II regulatory status, based on mounting evidence that these implanted tubes, catheters and cannulae belong in a lower-risk category.
The federal watchdog agency said there's enough safety and efficacy data to peel off a layer of regulatory oversight. Unlike the highest-risk Class III category, Class II devices are subject special controls, such as labeling rules and performance standards, but are exempt from the FDA's stringent pre-market approval protocol and its attendant clinical trial requirements.
The FDA pulled together draft guidance based on its review of relevant PubMed studies looking at the safety of implanted hemodialysis catheters. The guidance was also based on reports of adverse events and the agency's own pre-market review experience.