Daily Rules, Proposed Rules, and Notices of the Federal Government
If you need special accommodations due to a disability, please contact Cindy Garris, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4321, Silver Spring, MD, 20993-0002, 301-796-5861, email:
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FDA has included general topics in this document. Following the close of the call for abstracts, FDA and ASTM International members of the workshop organizing committee will determine the amount of time allotted to each presenter, the approximate time each oral presentation is to begin, and will select and notify participants by October 1, 2012. All requests to make oral presentations must be received by the close of the call for abstracts on September 1, 2012. If selected for presentation, any presentation materials must be emailed to Maureen Dreher (see
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Recent studies have identified promising results for the use of absorbable materials in implantable devices for endovascular therapies such as fully absorbable cardiovascular stents where the stent platform degrades, in addition to absorbable coatings. The use of these materials for cardiovascular indications, however, poses new risks due to the critical fatigue and mechanical loading demands that the implant must withstand and perform. Moreover, the optimal preclinical/bench testing paradigm to predict clinical performance of fully absorbable cardiovascular devices is not yet defined.
This public workshop will discuss the use of absorbable materials (including synthetic polymers as well as erodible metals) in medical devices across a broad range of indications with the aim of defining successful and unsuccessful methods to predict clinical performance, and will subsequently apply lessons learned to unique challenges for cardiovascular indications. Therefore, we invite presenters to share their experience with respect to cardiovascular and non-cardiovascular medical devices, both those that are fully absorbable and those with only a component or coating that is absorbable.
This public workshop will bring together the expertise of academia and industry professionals to define test methods as well as to educate and inform industry, academia, and device regulators on the performance and predictability of absorbable medical device degradation. Workshop participants will seek to define the critical factors for preclinical/bench testing and clinical predictability. They will then apply lessons learned from marketed devices for non-cardiovascular indications to the emerging uses of absorbable devices to treat cardiovascular disease.
Topics to be discussed at the public workshop include, but are not limited to:
• Correlations of in vitro and in vivo absorption
• Quantitative characterization of absorption kinetics
• Test methods to identify interactions of absorption with mechanical loading
• Test methods to assess mechanical performance of the absorbable product
The lessons learned from both early cardiovascular and well-established non-cardiovascular device experiences will be presented. These lessons will be discussed in the context of emerging cardiovascular uses of absorbable materials as part of a panel session at the end of the workshop.