Update: FDA workshop on medical devices for SDB


Drs. Neil Freedman and Barbara Phillips represented CHEST at an FDA workshop on April 16 on “Study Design Considerations for Devices Including Digital Health Technologies for Sleep-Disordered Breathing (SDB) in Adults. The other organizational participants were The American Academy of Dental Sleep Medicine; The American Academy of Neurology; the American Academy of Otolaryngology, Head and Neck Surgery; The American Academy of Sleep Medicine; and The American Sleep Apnea Association. Here are the questions that the FDA asked the panelists:

1. FDA is seeking to promote innovation and expedite the clinical development of devices intended for the diagnosis and treatment of sleep-disordered breathing (SDB). How should the following conditions (including their severity, eg, mild, moderate, severe, if appropriate) be defined for the purpose of creating appropriate inclusion/exclusion criteria for a clinical study for SDB devices?

a. Apnea

b. Hypopnea

c. Sleep-Disordered Breathing (SDB)

d. Obstructive Sleep Apnea Syndrome (OSAS)

e. Central Sleep Apnea Syndrome (CSAS)

f. Primary Snoring


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