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FDA Blames ‘Super Office’ Reorg For Falling Short On 2019 Review-Time Goals For Recalls, High-Risk Adverse Events

 
• By Shawn M. Schmitt

The US agency says it missed critical goals for evaluating product recalls and so-called Code Blue Medical Device Reports (MDRs) in fiscal year 2019 – and it’s pinning the blame squarely on a massive reorganization of its device center. This isn’t the first time the FDA has pointed to the “super office” shakeup as a disruptor.

FDA entrance sign 2016

The US Food and Drug Administration missed critical goals for reviewing medical device recalls and high-risk adverse event reports in fiscal year 2019 – and it’s placing the blame squarely on a massive reorganization of its device center.

In its FY 2021 budget request released on 10 February, the agency says it evaluated so-called Code Blue Medical Device Reports (MDRs) within 72 hours of receipt only 88%...

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