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The FDA pulled together draft guidance based on its review of relevant PubMed studies looking at the safety of implanted hemodialysis catheters.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.
Hemodialysis access devices were regulated as Class II until 1983, when the FDA re-categorized them in the highest-risk Class III status. However, based on data gathered since 2009, the agency recommended lowering the risk level a year ago.
The agency said the blood access devices have essentially been regulated as Class II for years. The move would formalize exemption from the rigorous PMA process.
Draft guidance documents "support reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls)," and "will be issued in conjunction with a Federal Register notice announcing the proposal to reclassify this device type." The agency is accepting comments until August 27.