FDA Offers Draft of Updated Engineering Tests for Stents, Delivery Systems

 

October 2, 2013
stents cath lab FDA update guidance delivery system

October 2, 2013 — The U.S. Food and Drug Administration (FDA) released a draft of its proposed updates for the non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems. It is designed to provide draft guidance for industry and FDA staff.

FDA has developed a guidance to inform the coronary and peripheral stent industry about selected updates to FDA’s thinking regarding certain non-clinical testing for these devices.  While FDA is in the process of making more substantial updates to the Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems guidance, it is issuing a “short guidance update” on select sections in order to notify the industry in a timely manner of its revised recommendations. 

Section III of the guidance provides cross-reference and updates to the related sections of the existing guidance.  Following the close of the comment period on this guidance, FDA intends to consider the comments received, revise this guidance as appropriate and publish it in final.  Simultaneously, FDA will issue an update to the existing guidance to cross-reference where this selected updates guidance supersedes the existing recommendations.  Subsequently, FDA will incorporate the elements of this final guidance into an anticipated revision of the entire Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems guidance.

Some updates the draft includes deal with material characterization, material composition, and biocompatibility.  The guidance can be found on FDA’s website.

For more information: www.fda.gov