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FDA’s Center for Devices and Radiological Health’s Continued Efforts to Return to Normal: Reopening for All Pre-Submissions
Since the beginning of the COVID-19 pandemic, the demand for medical devices has far exceeded anything we have seen in previous public health emergencies. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has worked to address these unprecedented demands, while continuing to fulfill our mission to protect public health and facilitate medical device innovation. However, the significant increase in workload has adversely impacted our premarket review times for both COVID and non-COVID medical devices and our ability to meet all requests for pre-submission meetings. Last year, we communicated about the steps we were taking to return our premarket program to normal operations. Today, we are providing an update.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
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