FDA’s Shuren: Staff Overburdened, Review Times Seeing Negative Effects
The head of the US agency’s device center tells Medtech Insight that while he’s proud of his staff for taking on the extra workload due to the pandemic, product review times are slowing because resources are stretched thin.
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According to top FDA officials Jeff Shuren and William Maisel, regulators approved, cleared and authorized 132 novel devices up from its previous record of 106. It’s in large part due to EUAs for novel COVID-19 products issued last year.
Exclusive: Top Medical Device Lobbyist On User-Fee Talks, Biden And New Congress, Implementing MCIT Rule
The MDMA’s Mark Leahey talked with Medtech Insight about how the medical device industry responded to the COVID-19 pandemic, plans for working with a new administration and Congress, and hopes for the MDUFA negotiations.
Makers of devices and tests granted emergency use authorization by the US FDA are being urged by the agency to not wait until the COVID-19 public health emergency is over to get their products approved – assuming they want to keep them on the market post-pandemic.