Currently, FDA logs reported adverse events into the MAUDE (Manufacturer and User Facility Device Experience) database—which Gottlieb admits is an incomplete and clumsy system. NEST, by contrast, is intended to accept not only reports from patients and caregivers, but also extract medical device problems from such sources as Medicare reimbursement procedure data—a gigantic, rich data mine. In the long run, a portion of higher medical device user fees would help pay for it.
“De Novo” Rule Change Also Proposed
In another change, the FDA is proposing a new pathway for “De Novo” and other devices. The proposed regulation was issued for public review and comment on December 7, 2018.
Currently, “De Novo” devices are automatically slotted under the Class III designation. The FDA wants to change that. Since many De Novo devices are noninvasive consumer products, the new rule would provide a pathway for commercialization as Class I or Class II devices. Incidentally (hint, hint) the comment period ends March 7, 2019.
