Peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Contributor(s):
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, April 14, 2023
Language(s):
English
Format:
Text
Subject(s):
Angioplasty, Balloon, Coronary
Cardiac Catheters
Device Approval
Government Regulation
United States
Genre(s):
Guideline
Technical Report
Abstract:
This guidance document provides recommendations, including bench testing and coating characterizations for 510(k) 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). These devices are catheter-based devices intended to treat lesions in the peripheral vasculature. This document provides anatomy-specific testing recommendations and expands on FDA’s current thinking for testing of these devices. FDA is issuing this guidance to clarify FDA’s premarket submission recommendations for PTA catheters and specialty catheters and to promote consistency across submissions. For the current edition of the FDA-recognized consensus standards referenced in this document, see the FDA Recognized Consensus Standards database at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” This document supplements other FDA documents regarding the specific content requirements of premarket submissions. You should also refer to 21 CFR 807.87 and FDA’s guidance, “Format for Traditional and Abbreviated 510(k)s.” In general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (26 pages))
NLM Unique ID:
9918662282706676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918662282706676