Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

FDA stent guidance: Agency releases 1guidance April 30 on non-clinical engineering tests and recommended labeling for intravascular stents and stent delivery systems. The document suggests what test data should be included and how data should be formatted. For example, the guidance makes testing recommendations regarding material composition, fatigue/durability, MRI safety and compatibility, crush and kink resistance, shelf-life and biocompatibility. The guidance covers self-expanding and balloon expandable stents used in coronary and peripheral arteries, as well as stents for other vascular indications; non-vascular stents and stents used in the intracranial vasculature are outside the scope of the guidance. Some of the recommendations are relevant to drug-eluting and biodegradable stents, but additional recommended tests for these devices are outlined in drug-eluting stent draft guidance, FDA notes. The document supersedes January 2005 guidance

You may also be interested in...



Corrosion Testing For Nickel Stents Front And Center In FDA Final Update

The agency says it has taken into account feedback from industry during a 2013 workshop on the risks of nickel stents, and has reduced its requirements for standard corrosion testing while also outlining steps on when to adopt different corrosion testing methods.

FDA Offers Partial Draft Guidance On Bench Tests For Stents

CDRH has put out a short draft update on some issues related to stent material testing as it develops a major update to its guidance on nonclinical engineering tests for stents.

Regulatory News In Brief

Baxter warning letter: Firm's Renal division, maker of HomeChoice peritoneal dialysis systems, MiniCaps disconnect caps and transfer sets, and Xenium dialyzers, is cited in a June 3 1warning letter for failing to comply with Medical Device Reporting and Quality System regulations. Baxter's internal systems do not assure timely identification and evaluation of potential MDR events, and the firm failed to submit MDR reports within the required 30-day window, FDA said. In addition, the company's corrective and preventive action procedures were found lacking. Baxter has received nine device-related warning letters since 1997, according to FDA's warning letter database

Related Content

Topics

UsernamePublicRestriction

Register

MT028833

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel