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[author: Heather Hatcher, Ph.D.] A year into the current public health emergency, the FDA’s Center for Devices and Radiological Health (CDRH) announced on Thursday, April 15, 2021, that the center is “prioritizing and triaging our work using existing resources in order to focus on our COVID-19 response, resulting in delays in some other work areas.” Dr. Jeff Shuren, Director, CDRH, and Dr. William Maisel, Director, Office of Product Evaluation and Quality at CDRH, reported that the astounding numbers of pre-EUA and EUA submissions received for COVID-19 tests and collection kits created a significant workload that has strained the center’s resources in the review of in vitro diagnostic (IVD) files. Shuren and Maisel report that current pre-EUA and EUA submissions under active review across the center exceeds 600 with an average receipt of more than 40 new pre-EUA and EUA submissions per week in addition to non-COVID-related submissions. Every office in CDRH has been heavily i

William maiselJeff shurenOffice of product evaluationRadiological healthProduct evaluationMedical device user fee amendmentsவில்லியம் மைசேல்அலுவலகம் ஆஃப் ப்ராடக்ட் மதிப்பீடுகதிரியக்கவியல் ஆரோக்கியம்ப்ராடக்ட் மதிப்பீடுமருத்துவ சாதனம் பயனர் கட்டணம் திருத்தங்கள்