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In Case You Missed It: Top 10 "Gray Sheet" Stories In November

Our most popular stories last month included an exclusive item on FDA's next steps for its device Case-for-Quality program; a graphical analysis of the agency's MDUFA III performance, three years into the program; a guest column from a former CDRH Office of Compliance director; and more.

Although positive feedback came out of a Center for Devices and Radiological Health test-run of an inspection approach targeting design and manufacturing elements deemed "critical" to the quality of implantable devices with batteries, the center decided not to move forward with the specialized inspection practice on a broader basis, but rather issue guidance documents on "critical-to-quality" topics.

That was the news from the most popular story on TheGraySheet.com

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