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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

 
• By Shawn M. Schmitt

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.

Crooked nail in the wooden board with a hammer - Image

A mere two dozen quality-related warning letters were sent by the US Food and Drug Administration to device-makers in calendar year 2018 – the fewest ever issued to companies since the agency's Quality System Regulation came into force 23 years ago.

The 24 letters (17 domestic, seven foreign) mark a decrease of 31% from 2017, when 35 manufacturers received missives – which, at the time, was a record low. (Also see...

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