FDA drafts guidance on stents

• Pre-market submissions
• Toxicity assessment of the drugs coating the stents
• Engineering and biocompatibility tests
• Animal studies involving the stents
• Objectives for drug-eluting stent trials
• Post-approval studies
• Adverse event reporting

The guidance does not apply to non-coronary drug-eluting stents, such as nonvascular biliary stents and peripheral drug-eluting stents, or stents with biological product components, such as cell or gene therapy. While the guidance makes recommendations relevant to stents with metallic stent substrates, it does not address stents that are degradable or made from other materials such as ceramics or polymers.

The guidance also includes a companion document that expands on some of the advice provided in the main draft guidance document.

The companion document:

• Focuses on recommendations for preparing an investigational device exemption application or a pre-market approval application and labeling a drug eluting stent
• Provides several examples of various submissions that sponsors provide to the FDA such as the Master Table, study summary, table of responses to deficiencies and test article certification

Public comments can be submitted in writing to the FDA by mail or via the Internet. AdvaMed and the FDA will offer a public workshop to clarify the recommendations on April 29.