2010-8311. Food and Drug Administration/National Heart Lung and Blood Institute/National Science Foundation Workshop on Computer Methods for Cardiovascular Devices: The Integration of Nonclinical and Clinical Models; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop entitled “FDA/NHLBI/NSF Workshop on Computer Methods for Cardiovascular Devices: The Integration of Nonclinical and Clinical Models.” The workshop will include a smaller, optional session entitled “Microstructure Modeling Session.” FDA is cosponsoring the workshop with the National Heart Lung and Blood Institute of the National Institutes of Health and the National Science Foundation. The purpose of the workshop is to facilitate discussion between FDA and other interested parties on the use of computational modeling in the design, development, and evaluation of cardiovascular medical devices.

Dates and Times: The optional session will be held on June 9, 2010, from 1 p.m. to 5:30 p.m. and the public workshop will be held on June 10 and 11, 2010, from 8 a.m. to 5 p.m.

Location: The public workshop and optional session will be held at the Hilton Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852.

Contact Person: Donna R. Lochner, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1110, Silver Spring, MD 20993, 301-796-6309, [e-mail].

Registration: To register for the public workshop and optional session, please visit the following Web site: http://scpd.stanford.edu/​publicViewHome.do?​method=​load. There is a registration fee to attend the public workshop to cover the expenses and attendees must register in advance. The fee for the meeting is $350. Students will be offered a discounted fee of $175. The exhibitors' fee is $600 and includes registration of one person. Fees will be waived for invited speakers and the organizing committee. The registration process will be handled by the Stanford Center for Professional Development. Although the facility is spacious, registration will be on a first-come, first-served basis.

If you need special accommodations because of a disability, please contact Donna R. Lochner at least 7 days before the public workshop.

SUPPLEMENTARY INFORMATION:

I. Why Are We Holding This Public Workshop?

The purpose of the public workshop is to facilitate discussion between FDA and other interested parties on the use of computational modeling in cardiovascular device design, development, and evaluation.

II. What Are the Topics We Intend to Address at the Public Workshop?

We hope to discuss a large number of issues at the public workshop, with our overall theme being the integration of computer and nonclinical models. Topics include, but are not limited to the following:

• Multiscale, multiphysics, and multiphase modeling;
• Modeling of cardiovascular diseases and therapies;
• Patient-specific modeling, including virtual surgical planning and predictive biomedicine;
• Open source projects, including public policy initiatives, database development and data presentation, and standards and protocols; and
• Regulatory issues with implementation of computer modeling.

III. Where Can I Find Out More About This Public Workshop?

Background information on the public workshop, registration information, the agenda, information about lodging, and other relevant information will be posted, as it becomes available, on the Internet at http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​default.htm

Dated: April 7, 2010.

Jeffrey Shuren,

Director, Center for Devices and Radiological Health.