The US Food and Drug Administration (FDA) plans to reclassify and implement new special controls for blood access devices used in hemodialysis.
In a 19 June 2012 Federal Register posting, FDA announced the release of its Draft Guidance for Industry and Staff: Class II Special Controls Guidance - Implanted Blood Access Devices for Hemodialysis, which it said serves "as the special control for implanted blood access devices." The draft guidance follows another Federal Register posting, also published 19 June, that reclassifies the devices from class III controls to class II special controls.
Class III controls currently serve as an ambiguous catch-all category for high-risk medical devices, while class II special controls establish specific conditions through which a device can bypass the requisite approval and notification procedures.
In its background explanation of the changed classification of the device, FDA noted its Gastroenterology-Urology Devices Panel had originally recommended the devices be classified with class II special controls back in 1981.
"Although FDA agreed with the panel recommendation for nonimplanted blood access devices," the agency explained, "FDA disagreed with the panel for implanted blood access devices and proposed that implanted blood access devices be classified into class III because FDA believed that the device 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. " The accessories to the implanted devices have been under class II controls since 1983, noted FDA.
As a result of recommendations from industry and improved analysis of the medical devices, which FDA explains have no moving parts and consists of just tubes and a dialysis machine, the agency is proposing to reclassify the devices under class II special controls. Comments on the proposed reclassification are due by 19 September.
So what does this mean for manufacturers of implanted blood access devices?
"If classified as a class II device … implanted blood access devices will need to comply with the requirement for special controls [and] manufacturers will need to address the issues requiring special controls as identified in the guidance document or by some other means that provides equivalent assurances of safety and effectiveness," wrote FDA.
The new controls, explains FDA, should be sufficient to provide "reasonable assurance of the safety and effectiveness of implanted blood access devices" while allowing exempting manufacturers from the premarket approval and premarket notification processes.
FDA - Gastroenterology-Urology Devices: Reclassification of Implanted Blood Access Devices
FDA - Draft Guidance for Industry and Staff; Class II Special Controls Guidance; Availability: Implanted Blood Access Devices for Hemodialysis