FDA Issues Final Guidance on 510(k) Submissions for Peripheral PTA Catheters

April 14, 2023—The FDA announced the availability of a final guidance, “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters—Premarket Notification (510(k)) Submissions.” The guidance is intended for industry and FDA staff to clarify the agency’s premarket submission recommendations for these devices.

As summarized in the FDA notification, this guidance document—which can be downloaded here—provides the FDA’s recommendations on nonclinical testing, animal studies and clinical studies (when warranted), and labeling to support premarket submissions for peripheral PTA balloon and specialty catheters (eg, infusion catheters, PTA balloon catheters for in-stent restenosis, scoring/cutting balloons). This guidance applies only to PTA catheters that are not combination products (ie, drug-coated PTA catheters).

The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral PTA balloon and specialty catheter submissions, noted the FDA.

The announcement is available in the Federal Register (88 FR 23089).

The FDA advised that comments on agency guidances may be submitted electronically on the Federal eRulemaking Portal at https://www.regulations.gov or may be submitted in paper by mail to: Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland, 20852. Specific instructions are available in the Federal Register announcement.

In January 2020, the FDA Center for Devices and Radiological Health announced the issuance of the draft guidance on 510(k) submissions for peripheral PTA and specialty catheters.