EVENT: “Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing in Adults”
DATE: Monday, April 16, 2018
TIME: 8 a.m. to 5 p.m.
COST: Free and open to the public; requires registration to attend (see below)
LOCATION: The FDA’s White Oak Campus (Silver Spring, Maryland)
SPEAKERS: American Academy of Sleep Medicine (AASM) President Dr. Ilene Rosen and AASM President-Elect Dr. Douglas Kirsch
TOPIC: Designing clinical studies to evaluate devices (including digital health technologies) meant for diagnosing, tracking, or treating sleep-disordered breathing (SDB), i.e. obstructive sleep apnea.
From the AASM website: “Anyone interested in attending this public workshop must register by April 9, 2018, by 4 p.m. Eastern Time. Public comments related to this workshop can be submitted to the FDA by April 30. A link to the transcript of the workshop will be available after approximately 45 days.”
Note: The meeting will be webcast and the link will be available via the FDA after April 9, 2018. (Registration is not required to view the webcast).