New FDA de novo guidance emphasizes complete applications
The FDA has released final guidance to clarify exactly what medtech companies need to include in their requests for the agency to review their applications for de novo approval.
The agency said it updated the guidance to comply with the Medical Device User Fee Amendments of 2017 goal to speed the product review process and to get safe and effective novel devices to the public.
The guidance includes checklists for manufacturers to fulfill to have their de novo requests for substantive review accepted and for recommended additional information. The updated process does not change the substantive review process for a device, the agency said. If some of the required information is missing, the manufacturer will have 180 days to supply it without resubmitting the entire request unless the agency says otherwise.
The entire guidance, including the checklists, can be found here.