https://www.fda.gov/regulatory-information/search-fda-guidance-documents/peripheral-percutaneous-transluminal-angioplasty-pta-and-specialty-catheters-premarket-notification?utm_campaign=2020-01-10%20PTRA%20Specialty%20Catheters%20Draft%20Guidance&utm_medium=email&utm_source=Eloqua

FDA Issues Draft Guidance on Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions.

Read the Guidance This draft guidance provides proposed premarket submission recommendations for class II PTA balloon catheters regulated under 21 CFR 870.1250 and class II specialty catheters regulated under 21 CFR 870.1210 and 21 CFR 870.1250, including: Non-clinical performance testing, including bench testing and animal testing for PTA catheters and specialty catheters. Device labeling and device modifications. Once finalized, this guidance will clarify the FDA’s premarket submission recommendations for PTA catheters and specialty catheters to promote consistency across submissions for these medical devices.  Submit Comments on the Draft Guidance This draft guidance will be open for public commens for 60 days at https://www.regulations.gov under Docket Number FDA-2019-D-5422. Questions? If you have any questions about this guidance document, contact the Division of Industry and Consumer Education (DICE).