05/31/2022
Photo by Clay Banks on Unsplash
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDER) announced that they have opened for all pre-submissions. During the pandemic, CDRH prioritized Emergency Use Authorization (EUA) for devices specifically related to the pandemic. In that same time, they also received a large number of non-pandemic related premarket submissions (510(k), De Novo, PMA), requests for Emergency Use Authorization (EUA), and In Vitro Diagnostic (IVD) Pre-Submissions. These large numbers plus their pandemic-focus impacted their ability to timely review premarket submissions, EUA requests, or honor all requests for pre-submission meetings. With additional funding from Congress and additional staffing, CDRH is addressing the non-pandemic submissions and pre-submissions. CDRH will accept all non-COVID IVD pre-submissions starting June 1, 2022, although likely following an extended timeline.
You may also be interested in our blog “MDUFA V Proposed Recommendations for Reauthorization Ready for Public Meeting”. CDER’s recommendations are currently being reviewed by Congress.
- The Clinical Pathways Team
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