Henry Ford physician selected as panelist for FDA panels on medical device regulation
– Kathleen Yaremchuk, M.D, MSA, Chair of the Department of Otolaryngology-Head and Neck Surgery at Henry Ford Hospital, will serve as a panelist at a U.S. Food and Drug Administration (FDA) public workshop regarding the regulation of medical devices for sleep disordered breathing (SDB). The workshop will take place from 8 a.m. – 5:30 p.m. today at the FDA White Oak Campus in Silver Spring, Maryland.
The goal of the workshop is to expedite innovation and patient access to sleep apnea devices. Panelists will discuss the appropriate design of clinical studies to evaluate devices, including digital health technologies intended for the diagnosis, monitoring or treatment of SDB.
Dr. Yaremchuk will serve as a panelist on two of the workshop's panels, including:
- Defining SDB Conditions for Clinical Trials
- Clinical Trial Design Considerations for therapeutic SDB Devices
Dr. Yaremchuk is board certified in Otolaryngology-Head and Neck Surgery and Sleep Medicine. She is a member of the Division of Sleep Medicine at Henry Ford Hospital and Clinical Professor of Otolaryngology at Wayne State University School of Medicine.
She has authored multiple papers and book chapters on surgical outcomes and quality of life in patients with obstructive sleep apnea. She is the immediate past Chair of the Sleep Disorders Committee for the American Academy of Otolaryngology/Head & Neck Surgery.
To view a live webcast of the event, visit http://ow.ly/DFi830jvO3x.