CDRH Official Links Reorg To Drop In Warning Letter Count
Far fewer warning letters are being issued by the US FDA’s device center than in previous years. A center compliance official said that in addition to changes in enforcement practices, the drop was also influenced by CDRH’s recent move to centralize device review staff in the so-called “super-office.”
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FDA Blames ‘Super Office’ Reorg For Falling Short On 2019 Review-Time Goals For Recalls, High-Risk Adverse Events
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.
Warning Letter Nosedive: FDA Makes History (Yet Again) By Sending Only 21 Of The Missives To Device Firms In 2019
A mere 21 quality-related warning letters were issued to device makers last year, the US agency tells Medtech Insight. It’s the third year in a row that the FDA has given out a record-low number of letters. In fact, 2019’s count of 21 represents a whopping 83% decrease from just five years ago, when 121 letters were sent to companies.
A Record-Low 24 Warning Letters Were Sent To Device Firms In 2018. That's Because A 'Big Hammer' Isn't The Best Tool To Ensure Compliance, FDA Says
Only two dozen quality-related warning letters were sent by the US agency to device-makers in calendar year 2018 – the fewest ever issued to companies since the FDA's Quality System Regulation came into force in 1996. Two FDA officials share with Medtech Insight probable reasons for the decline in the enforcement missives, from regulatory meetings with firms to untitled letters, and more.