June 6, 2022 - COVID-19, FDA, Healthcare, Regulatory

FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests

Lindy Pittman, Summer Associate in Washington, D.C., contributed to the drafting of this post.

The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD) tests, not just COVID-19 tests. During the height of the pandemic and while inundated with COVID-related submissions, CDRH restricted the IVD tests it would review in order to best address the public health crisis. Starting June 1, 2022, CDRH is again accepting all IVD pre-submissions, both COVID-related and other. However, the Center did include the caveat that non-COVID pre-submissions will likely still face an extended timeline, given the ongoing pandemic and associated workload.

In another return to normalcy, CDRH plans to rescind an additional COVID-era policy that extended the grace period for deficient marketing submissions. Recognizing the effect the pandemic had on business operations, CDRH did not consider an application automatically withdrawn if CDRH did not receive a response by a certain date. Moving forward, the Center will be returning to its previous guidelines that require either a complete response or an extension request within the specified time. This policy change will go into effect 30 days after the official announcement from the FDA in the Federal Register, planned for June 7, 2022.

For another point to watch, the Medical Device User Fee Amendment (MDUFA) commitment letter is currently moving through Congress. CDRH has committed to increasing communication between the FDA and submission applicants in order to reduce wait times.