Although 97% of the patients in the study were white and no black patients were enrolled, none of the panelists thought that there was any reason to expect the device would not be effective in other racial and ethnic groups. The company should include more diverse populations in postmarketing studies, the panel said.
The company has proposed a postmarketing study and is developing a training program for surgeons, sleep physicians, and support staff, including nurses.
The FDA usually follows the recommendations of its advisory panels. Advisory panel members have been cleared of potential conflicts related to the meeting topic. Occasionally, a panelist is given a waiver, but no waivers were given at this meeting.