Public Workshop ? Acute Ischemic Stroke Medical Devices Trials Workshop, October 6, 2015

The Food and Drug Administration (FDA) is announcing a public Workshop “Acute Ischemic Stroke Medical Devices Trials.”

The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for acute ischemic stroke emerging technologies and help to speed development and approval of future submissions.


Date, Time and Location:

This meeting will be held October 6, 2015, beginning at 1:00 p.m. – 5:30 p.m. at the following location:

Bethesda Pooks Hill Marriott
5151 Pooks Hill Road
Grand Ballroom
Bethesda, MD, 20814

Link for Bethesda Pooks Hill Marriott (Airports, Directions, Lodging Accommodations, Public Transportation, etc.): http://www.marriott.com/hotels/maps/travel/wasbt-bethesda-marriott/

The workshop will be videotaped and posted to the web page after the workshop.

[email protected].

[email protected]

Jamie Waterhouse, Project Manager, Neurointerventional and Neurosurgical Devices Branch, Division of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3063, [email protected]