Medical Devices

Public Workshop - Cardiac Troponin Assays, November 28, 2017

The Food and Drug Administration (FDA) announced the following public Workshop entitled "Cardiac Troponin Assays." The purpose of the workshop was to discuss the development of innovative troponin assays designed to aid in the diagnosis of Myocardial Infarction (MI) and additional clinical uses of these assays. The workshop was intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with the analytical and clinical validation methods for troponin assay devices.


Date, Time and Location

This meeting was held November 28, 2017, beginning at 8:30 a.m. - 5:00 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Agenda

TimeTopicsPanel
8:35-8:45 a.m.Introduction/Welcome Remarks 
8:45-9:30 a.m.Cut-Off Determination/Reference Interval StudiesFred Apple, Ph.D., Jeff Bishop, Ph.D., Rob Christenson, Ph.D., Amy Saenger, Ph.D., Dina Greene, Ph.D., Norberto Pantoja-Galicia, Ph.D., Jackie Wieneke, M.D., and Stayce Beck, Ph.D. (moderator)
9:30-9:45 a.m.Break 
9:45-10:55 a.m.Clinical Trial DesignChristopher deFilipi, Ph.D., Allan Jaffe, M.D., James McCord, M.D., Richard Mowak, M.D., Zivjema Vucetic, M.D., Ph.D., Paula Caposino, Ph.D., Jackie Wieneke, M.D., and Courtney Lias, Ph.D. (moderator)
10:55-12:00 p.m.Pre-Analytical And Analytical Considerations For Clinical TrialsFred Apple, Ph.D., Rob Christenson, Ph.D., Dina Greene, Ph.D., Jane Phillips, Ph.D., Amy Saenger, Ph.D., Paula Caposino, Ph.D., Kerry Welsh, M.D., Ph.D, and Brittany Schuck, Ph.D. (moderator)
12:00-1:00 p.m.Lunch 
1:00-2:10 p.m.Clinical Trials For Point Of Care DevicesAnna Marie Chang, M.D., Allan Jaffe, M.D., James McCord, M.D., Frank Peacock, M.D., Rick San George, Ph.D., Juliane Lessard, Ph.D., Paula Caposino, Ph.D., and Kellie Kelm, Ph.D. (moderator)
2:10-2:25 p.m.Break 
2:25-3:15 p.m.Use Of Existing Clinical Data To Support ClaimsAnna Marie Chang. M.D., Rakesh Engineer, M.D., Alberto Gutierrez, Ph.D., Karen Richards, Yader Sandoval, M.D., Kellie Kelm, Ph.D., Courtney Lias, Ph.D., and Ian Pilcher (moderator)
3:15-4:15 p.m.Public Comments 
 Closing Remarks 

Webcast Archive and Slides

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Food and Drug Administration, Center for Devices and Radiological Health, Office of Communication and Education, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov.

For questions regarding workshop content please contact: Paula Caposino, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4644, Silver Spring, MD 20993, 301-796-6160, Paula.Caposino@fda.hhs.gov.

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