FDA Updates Guidance on 510(k) Submissions for Atherectomy Devices
July 20, 2020
The FDA has issued draft guidance updating its February 2020 guidance on 510(k) submissions for peripheral vascular atherectomy devices.
An updated software section recommends providing additional information on devices that can exchange information through an electronic interface with another product, system or device.
The draft guidance also includes new sections on test samples for finished products, and it offers recommendations on testing methods for atherectomy devices.