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.