Sleep Apnea, the FDA, and Medical Devices—A Surgeon’s Perspective
John Heerdink spoke to Eric Kezirian, MD, MPH during Episode 2 of the Groundwork Forum Podcast about “Sleep Apnea, the FDA, and Medical Devices—A Surgeon’s Perspective”.
Dr. Kezirian discusses obstructive sleep apnea and its current treatments as well as his work with medical device companies and the U.S. Food and Drug Administration pathways that allow medical devices to reach the U.S. market.
During the last several years, the FDA pathways for medical devices have come under fire from numerous groups. The Institute of Medicine’s 2011 report raised concerns about the FDA’s 510(k) clearance process for moderate-risk devices.
Similarly, the FDA Premarket Approval process for high-risk devices has emphasized pre-approval studies without enough monitoring after receiving approval. The FDA has taken steps to improve these pathways, but there are important implications for medical device companies and new technologies that treat complex medical conditions like obstructive sleep apnea.
Dr. Kezirian is a Professor in the USC Caruso Department of Otolaryngology—Head and Neck Surgery at the Keck School of Medicine of USC in Los Angeles. He is recognized by colleagues as an international leader in surgery for obstructive sleep apnea and snoring. As one of the world’s relatively few surgeons dedicated to sleep apnea surgery, he has worked with many established and startup medical device companies focused in this field.
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