The FDA may not be able to meet its deadlines for reviewing medical device applications due to constraints posed by the coronavirus pandemic, Commissioner Stephen Hahn announced yesterday.
The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) are still on track to meet the goals set in user-fee agreements, but that doesn’t mean they will necessarily continue to do so, according to Hahn.
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