Webinar: Strategies for Getting Your De Novo Device Approved
Hogan Lovells attorney Kelliann Payne offered some best practices for getting de novo products through the FDA’s review process, in a recent FDAnews webinar, noting the agency has streamlined its de novo pathway and made it more accessible for medical devices in the low-to-moderate risk category.
FDA review times for de novo applications used to be longer than for premarketing applications, but that is beginning to change, Payne said.
In terms of application volume, data requirements and FDA review time, the de novo pathway typically falls between the 510(k) and the PMA.
Access the webinar De Novo Strategies for Getting Your Medical Device Approved here.