News from the FDA/CDC

FDA meeting on medical devices for sleep apnea scheduled


 

The Food and Drug Administration will host an open meeting about medical devices to diagnose and treat sleep apnea on April 16.

In a statement sent to members, CHEST invited all to attend this open meeting, which will be held at the FDA White Oak Campus in Silver Spring, Md.

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The agency is soliciting ideas and opinions about criteria or processes for FDA review of medical devices to diagnose or treat sleep apnea, according to the statement. CHEST will be represented by Neil Freedman, MD, and Barbara Phillips, MD, who also welcomed input by email prior to the meeting. Home testing, “apps,” and the criteria to diagnose sleep apnea and/or its resolution are among the topics to be discussed. The meeting will be webcast and the link for joining the meeting will be posted after April 9 on the FDA announcement page. No registration is required.

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