FDA Revises Guidance on 510(k) Submissions for Atherectomy Device

The FDA has released final guidance on 510(k) premarket submissions for peripheral vascular atherectomy devices, taking into mind comments submitted by a high-profile devicemaker.

The guidance, which outlines information devicemakers should include in their submissions for intraluminal artery strippers, incorporated certain suggestions from a sole commenter on the draft, Cook Group.

For example, the agency backtracked on its recommendation to identify device measurement tolerances when comparing substantial equivalence with the reference product, taking Cook Group’s advice to include dimensional characteristics — such as length and cutter dimensions — as a comparison instead.