Report: FDA Greenlit Record Diagnostics, Improved PMA Decision Times Despite COVID-19
Despite industry concerns the US FDA may be significantly falling behind on non-COVID-19 product reviews, analysts at Wells Fargo find that the agency has actually improved in areas such as PMA decision times.
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A Chat With Jeff Shuren: FDA Device Center Chief Worries About Agency Staffing; Talks MDUFA V, Pandemic, More
The head of the US agency’s device center spoke with Medtech Insight in an exclusive wide-ranging interview about his priorities for the future, the nuances of the MDUFA V user-fee negotiations, how COVID-19 has changed the agency, and more.
Recalls initiated by the medical device industry were relatively stable in the first quarter of 2021 as companies recalled 212 products, a 10% decrease from the previous quarter. Check out our Q1 recalls infographic for more.
The most recent Medical Device User Fee Amendments meeting minutes expose how the US agency and the medtech industry continue to disagree over the agency’s previous user-fee commitments and desire to get more funding.