AdvaMed Supports Splitting Up Class II Devices, But On Its Own Terms

Article preview from "The Gray Sheet" - October 04, 2010

Medical device makers are sending FDA a message that while they support some formal distinctions within the broad range of Class II devices, the creation of a "Class IIb" subset goes too far.

AdvaMed Supports Splitting Up Class II Devices, But On Its Own Terms

Article preview from "The Gray Sheet" - October 04, 2010

In a recent report assessing the 510(k) process, FDA floated the idea of dividing the current Class II into "a" and "b" subsets to make it clear which types of 510(k) device submissions will "typically" require clinical information, manufacturing information or post-market study evaluation (¹"The Gray Sheet" Aug. 9, 2010).

FDA seems to think it has general buy-in from industry, but trade group AdvaMed clarified in Sept. 21 comments that it does not support FDA's approach.

AdvaMed submitted its own proposal to FDA in May for delineating a "small, focused subset" of Class II products that may require additional pre- and post-market information to support a clearance decision. The subset would reflect device risk and how well the technology is understood, and would typically include implants and life-sustaining and life-supporting devices, AdvaMed said.

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