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FDA Hasn't Publicly Released A Device-Related Close-Out Letter For 5 Months, Defeating Purpose Of Program

 
• By Shawn M. Schmitt

Medical device manufacturers under the dark cloud of a US FDA warning letter work hard to close them out, and, importantly, receive a close-out letter from the agency that is posted online for everyone to see. Yet FDA hasn't publicly released such a missive to device companies since May – the longest gap since the close-out program began in 2010. FDA says it's aware of the problem.

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Where, oh where are the close-out letters?

Are you a regulatory wonk who scours US FDA's website for up-to-date warning letter close-outs? Well, good luck finding any.

The agency has not released a device-related close-out letter for more than five months – the first time it has...

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