Update: FDA workshop on medical devices for SDB

3. FDA has received an increasing number of premarket applications for devices intended to treat SDB. How should studies for the various technologies (eg, intra-oral appliances, externally worn devices, electrosurgical devices for tissue reduction, and passive or active implantable devices of the upper airway) be designed with respect to the following factors (please consider whether your recommendations would vary if the device was an implant vs an externally worn device):

a. What is the most appropriate control group (eg, comparison to baseline measures, randomization to a concurrent control group)?

b. What is the minimum duration of the study? For implants and surgical procedures, how long after the intervention should the effectiveness endpoint be assessed?

c. What objective parameter or combination of parameters should be used for the primary effectiveness endpoints (eg, AHI, ODI, T90, or other non-PSG/HSAT parameters)?

d. What would be a clinically meaningful difference for the above primary effectiveness endpoint(s) between/among study arms or within a study arm?

e. What patient-reported outcomes (PROs) are appropriate in the evaluation of SDB devices?