In 2009, FDA authorized just 29 novel devices; in 2015 it authorized 86; and five years later the number hit 132 novel devices. 2020 was a year for innovation, but the COVID-19 pandemic was only partially responsible. In an FDA Voices blog authored by CDRH Director Jeff Shuren, M.D. and William Maisel, M.D., director of CDRH’s Office of Product Evaluation and Quality, the center heads reflected on the record number of medical devices authorized last year and called out the “boundless dedication of CDRH staff” in moving these efforts forward.
To be clear “novel devices” are medical devices brought to market via PMA, 510(k) clearance, humanitarian device exemption, De Novo pathways, or emergency use authorization. “Novel or innovative does not simply mean ‘new.’ They address an unmet need, or may be safer or more effective than currently available alternatives. For FDA-approved and FDA-cleared medical devices, innovation, and safety are two sides of the same coin,” wrote Shuren and Maisel.
Some highlights from last year’s novel authorizations include the first game-based digital therapeutic to improve attention function in children with ADHD; an ACL implant that can be used as an alternative to ACL reconstruction; the first cardiac ultrasound software that uses artificial intelligence to help the user capture images of a patient’s heart; and the first insulin delivery and monitoring system that automatically adjusts insulin delivery for pediatric patients.
Shuren and Maisel also cited other agency efforts that are facilitating faster review of novel devices, including the launch of the Digital Health Center of Excellence and the Breakthrough Devices Program. They noted that this year COVID-19 will continue to be the agency’s top priority.