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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-5422.