In September, FDA announced the creation of a Patient Engagement Advisory Committee made up of nine core voting members, plus a voting consumer representative and a nonvoting industry representative, that will advise the agency on “ issues relating to medical devices, the regulation of devices, and their use by patients.”
Also this year, FDA’s Patient Preference Initiative, launched in 2013, took a few leaps forward. In January, the agency published a study on incorporating patient-preference evidence into regulatory decision-making, and later that month it approved the Maestro Rechargeable System, a surgically implanted device for treating obesity, in part based on the results of a patient-preference survey. May brought the release of a draft guidance detailing best practices for patient preference studies.
|Start 2016 off right by attending MD&M West, the world's largest medical design and manufacturing event, February 9-11, at the Anaheim Convention Center.|