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Shuren: ‘You Can’t Be Expecting Us To Just Sit Back’

 
• By Elizabeth Orr

In a wide-ranging speech at FDLI’s 2023 annual meeting, CDRH director Jeffrey Shuren pledged to move forward with regulatory action on lab-developed tests and sketched plans for improved regulation of medical apps.

Jeff Shuren

When the US Congress failed to pass diagnostics reform with last year’s user fee reauthorization package, Food and Drug Administration officials said the omission might nudge regulators to act administratively rather than waiting for Congress.

Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, reaffirmed that approach during a 17 May speech at the Food and Drug Law Institute (FDLI)’s annual conference...

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More from Policy & Regulation

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