Medical Devices

Public Workshop - Cardiac Troponin Assays, November 28, 2017

The Food and Drug Administration (FDA) is announcing the following public Workshop entitled "Cardiac Troponin Assays." The purpose of the workshop is 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 is 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 will be 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

The meeting will be webcast and the webcast link will be available on this page after November 21, 2017 (Registration is not required to view the webcast).

Preliminary Agenda

TimeSubjectName of Speaker/
TBAFDA perspective on troponin clinical trialsTBA
TBACut-off determination studies/reference interval studiesPanel discussion
TBAClinical trial designPanel discussion
TBAPre-analytical and analytical considerations for clinical trialsPanel discussion
TBAClinical trials for Point-of-care devicesPanel discussion
TBAUse of existing clinical data to support claimsTBA
60 minutesOpen Comment SessionTBA

Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by 4:00 p.m. on November 17, 2017.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

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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,

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,

Page Last Updated: 08/09/2017
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