The FDA issued draft guidance this week to officially lower the risk category for implanted blood access devices used during hemodialysis, updating classification of the devices in light of improvements in medical understanding and the agency’s existing practices.
The measure would categorize the devices as Class II, a motion that was initially suggested by the agency’s gastroenterology-urology devices panel in 1981 and has effectively been in practice for many years.
The 1981 FDA panel recommended Class II labeling for both implanted and non-implanted hemo access devices, but the FDA decided at the time that implanted blood access devices "presented a potential unreasonable risk of illness or injury to the patient if there are not adequate data to assure the safe and effective use of the device," according to FDA documents.
The FDA in 1983 classified implanted hemo access devices as Class III, the highest-risk category, and in 1987 updated that language while maintaining Class III status. The devices are currently handled "in a fashion similar to Class II devices" with the devices heading to market under with 510(k) clearance, but the new rule would formalize current practice.
The agency began collecting information in 2009 on implanted blood access devices in order to support reclassification, receiving manufacturer assurance that clinical testing was not required to assure safety and effectiveness of the devices.
"FDA has been reviewing these devices for many years and their risks are well known," according to a notice published in the Federal Register. "This rule brings the formal classification of implanted blood access devices into line with current practice and will likely cause little to no change in behavior on the part of industry, consumers, or FDA."
Implanted blood access devices use tubes, such as catheters, cannulae or hollow needles, placed into a central vein to allow vessel access for blood removal and cleaning through a hemodialysis machine. The access devices themselves have no moving parts, consisting essentially of flexible tubes and a locking mechanism for connecting to a blood filtration machine.
The FDA determined "on its own initiative" that new medical information demonstrates that special agency controls "would provide reasonable assurance of safety and effectiveness," deciding that the devices need not undergo the more rigorous pre-market approval process.
"FDA believes that implanted blood access devices should be reclassified into class II because special controls, in addition to general controls, can be established to provide reasonable assurance of the safety and effectiveness of the device," according to an agency report. "Since 1987 when FDA classified implanted blood access devices into class III, sufficient evidence has been developed to support a reclassification to Class II with special controls."
The FDA is accepting comments on the reclassification bid until September 18, 2012.
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