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Cybersecurity And LDT Enforcement Top FDA’s Guidance Priorities for 2025

 
• By Elizabeth Orr

The US FDA has released its annual list of planned guidance documents for the upcoming fiscal year. While many topics on the list are familiar, a new “Under Construction” list shows rising priorities.

Man in suit holding wooden blocks spelling 2025, with a bullseye replacing the zero.
• Source: Shutterstock

Watch for final US Food and Drug Administration guidance documents on cybersecurity, laboratory-developed tests, and the use of real-world evidence in 2025, the Center for Devices and Radiological Health said in a round-up of current guidance priorities released on 10 October.

Each October, the center announces the draft and final guidance documents it plans to work on in the new fiscal...

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More from Policy & Regulation

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
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With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
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