Update: FDA workshop on medical devices for SDB

4. What are the safety and effectiveness concerns when a digital health device provides a diagnosis and monitoring of SDB?

a. What factors are important in developing a reference database (eg, demographics, validation)?b. What are the important safety and effectiveness concerns for SDB digital health devices used in the following settings:

i. A physician office or sleep center environment?

ii. A nonclinical environment?

iii. Prescription vs OTC use?

There was significant discussion and quite a bit of controversy. Among the recommendations to the FDA were that home testing is adequate and acceptable for clinical trials, that the ODI4 is more predictive and reliable than the AHI, and that the syndrome of OSAHS includes symptoms, one of the most important of which is sleepiness. It was acknowledged that digital health devices have the potential to greatly increase access to diagnosis, but access to treatment will need to be addressed, as well. I think this was a very important meeting, and the outcome will likely impact our members. The ultimate goal is to publish a paper about recommended techniques, outcomes, and inclusion characteristics/definitions to be used in clinical trials for new devices to diagnose or treat sleep apnea.