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

Executive Summary

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.

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% of the time in FY ’19. Its goal had been 90%.

The FDA further says it reviewed and classified recalls in a timely fashion 84% of the time in FY 2019, just shy of its goal of 85%.

The agency had previously exceeded its goals for reviewing Code Blue MDRs (92%) and recalls (89%) in FY 2018.

The FDA says it didn’t meet those same goals in FY ’19 because it launched its Office of Product Evaluation and Quality (OPEQ) last May.  (Also see "Day 1: US FDA Launches New 'Super Office,' Says It’s Already Proven Its Worth" - Medtech Insight, 1 May, 2019.)

“During the initial months of the reorganization, [performance targets were] not always met due to the inexperience of the new staff.” – US FDA

That reorg essentially dissolved and replaced the Office of Compliance, the Office of Surveillance and Biometrics, and the Office of Device Evaluation with the OPEQ "super office," fulfilling a so-called "total product life cycle" (TPLC) scheme the agency has long envisioned. (Also see "US FDA Device Center Pushes 'Total Product Life Cycle' Concept; 'Reorganization' Coming, Says Compliance Chief" - Medtech Insight, 19 Apr, 2017.)

“In support of TPLC, many staff acquired new reviewer responsibilities, requiring additional training and learning curves,” the FDA says in its new budget request. “During the initial months of the reorganization, [the performance targets for Code Blue MDRs and recalls were] not always met due to the inexperience of the new staff.”

The agency notes, however, that since May 2019 it has “consistently met or exceeded the 90% target” for reviewing the high-risk MDRs. The FDA also says it has “seen a 20% increase in recall processing times” in FY 2020.

This isn’t the first time the FDA has pointed to the reorg of its Center for Devices and Radiological Health (CDRH) as a disruptor. In December, Erin Keith, associate director for compliance and quality at the CDRH, partially pinned a drop in the number of warning letters on the center shakeup.

Keith said the reorg “was very disruptive to the compliance process,” adding that process delays made it harder for the agency to meet its 120-day statutory deadline for sending warning letters. (Also see "CDRH Official Links Reorg To Drop In Warning Letter Count" - Medtech Insight, 16 Dec, 2019.)

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