Questions Remain On FDA Opioid Device Innovation Challenge

Key questions loom regarding FDA's plan to offer select sponsors of opioid treatment and prevention devices special treatment in the review process, including what reimbursement pathways may be available, how many sponsors FDA will select and how the streamline review approach will differ from the breakthrough designation. FDA officials shed little light on these issues during a July 25 webinar with stakeholders. FDA announced in May that it would offer selected sponsors of devices that treat or prevent opioid use...