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GUIDANCE DOCUMENT

Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff April 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2019-D-5422
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides the FDA’s recommendations on non-clinical testing, animal studies and clinical studies (when warranted), and labeling to support premarket submissions for peripheral percutaneous transluminal angioplasty (PTA) balloon and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons). This guidance applies only to PTA catheters that are not combination products (i.e., 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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-5422.

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