Shuren: ‘You Can’t Be Expecting Us To Just Sit Back’
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.
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Medcon 2023: Shuren Mulls New Pathway For Digital Devices
The head of the US FDA’s Center for Devices and Radiological Health said that an optional new pathway could help the agency regulate the flood of novel devices intended for at-home use. His presentation also touched on MDUFA V implementation, post-pandemic strategy, and CDRH staffing needs.
Diagnostics Reform Reintroduced in House
The VALID Act, which will hand diagnostics oversight to the US FDA, has been reintroduced in the House of Representatives after it failed twice last year in Congress.
FDA Finalizes Guidance Documents Aimed At Easing Post-Pandemic Regulatory Transitions
The documents describe the US agency’s preferred approach toward products cleared under EUAs or other alternate approaches during the COVID-19 public health emergency.