A new draft guidance document just released by the US Food and Drug Administration (FDA) pertains to implanted blood access devices for hemodialysis, a type of device used as part of an artificial kidney system that FDA says it wants to down-classify from a high-risk Class III medical device to a moderate-risk Class II device regulated with special controls
Under FDA's regulatory paradigm, nearly all Class III medical devices require a premarket approval (PMA) application to be submitted to and approved by FDA before being allowed to be marketed. The process is a lengthy and expensive one, requiring the submission of extensive clinical data, a costly filing fee and potentially a hearing before an FDA advisory committee.
Class II medical devices, meanwhile, are most often subject to the premarket notification process, which requires far less (and often no) clinical data to support the safety or efficacy of a medical device. The submissions, also known as 510(k) submissions, instead rely on extensive preclinical data and a determination by FDA that a device is substantially equivalent to an already-approved (low- or moderate-risk) predicate device under the theory that if the predicate was found to be safe and effective, the follow-on device is highly likely to be safe and effective as well.
Thus, a down-classification of a device from Class III controls to Class II special controls would permit more devices to take advantage of the 510(k) pathway, easing their path to market.
FDA is now proposing to do exactly that, with the added assistance of a guidance document meant to help sponsors jump the remaining regulatory hurdles.
In a 27 June 2013 Federal Register posting, FDA issued a proposed administrative order to reclassify implanted blood access devices as Class II devices subject to special controls, reversing a 1983 order that put them into the Class II category (though their accessories have been Class II devices since 1983).
FDA had already made clear its intent to down-classify the devices in June 2012, but the 2012 passage of the FDA Safety and Innovation Act (FDASIA) had introduced new reclassification procedures, necessitating the re-release of the proposed rule.
The devices, FDA confirmed again today, will be able to be cleared through FDA's 510(k) pathway.
The guidance document co-released along with the proposed rule provides additional recommendations on how to obtain FDA clearance for the devices with minimal setbacks.
The guidance explains that an implanted blood access device for hemodialysis is defined as:
"a prescription device used for hemodialysis and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes: Single, double, and triple lumen catheters with cuffs, subcutaneous ports with catheters, shunts, cannula, vessel tips, and connectors specifically designed to provide access to blood."
Regulators wrote that sponsors of the products should first identify their respective devices using this recommendation, a product code, a common name for the device, a trade or proprietary name, a classification name, a listing of all known model numbers, a description of the device's use, and the Code of Federal Regulations (CFR) regulation under which the device is regulated.
As with most 510(k)s, sponsors should also take care to include design details about the device (including pictures, samples or diagrams for reference), as well as a comparison of the device to a legally marketed predicate relative to its intended use, indications for use, materials used, performance specifications and design parameters.
Additional testing should include biocompatibility testing, performance/bench testing, sterility and shelf life testing and non-clinical testing. In some rare cases, such as if the indications for use are "dissimilar from legally marketed devices" or use different technology, FDA may require the submission of clinical data if no alternatives for testing exist.
Comments on the draft guidance are being accepted for 60 days.
Draft Guidance: Implanted Blood Access Devices for Hemodialysis
Proposed Rule on Implanted Blood Access Devices