Advertisement

January 13, 2020

FDA Issues Draft Guidance on 510(k) Submission for Peripheral PTA Catheters

January 13, 2020—The FDA Center for Devices and Radiological Health has issued a draft guidance regarding 510(k) premarket notification submissions for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters. The draft guidance is intended for industry and FDA staff to clarify the agency’s premarket submission recommendations for these devices and to promote consistency across submissions.

The document is available online here. The FDA is seeking comments by March 13, 2020, which should be submitted either online or in writing to Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061 in Rockville, Maryland, 20852. All written comments should be identified with the document's docket number: FDA-2019-D-5422.

According to the FDA, the document provides draft recommendations including bench testing and coating characterizations for 510(k) submissions for peripheral PTA balloons and specialty catheters (eg, infusion catheters, PTA balloon catheters for in-stent restenosis, scoring/cutting balloons) that are intended to treat lesions in the peripheral vasculature. This document provides anatomy-specific testing recommendations and expands on the FDA’s current thinking for testing of these devices.

Advertisement


January 13, 2020

German Analysis Shows Long-Term Survival With Paclitaxel-Coated Devices Used for Femoropopliteal Artery Revascularization

January 10, 2020

Enrollment Completed in PRESTIGE BTK Trial of MedAlliance’s Selution SLR Device