The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has issued its guidance priorities for 2025 (available here).
Top of these priorities includes guidances on enforcement discretion for Laboratory Developed Tests (LDTs) and creating quality systems regarding cybersecurity for medical devices. Additionally, FDA intends to issue a guidance on marketing submissions for predetermined change control plans for artificial intelligence-enabled device software.
All of these guidances are considered "A-list" priority for publication signaling they are the highest priority for publication for next year.
Those who are interested in these issues should continue to monitor FDA guidance releases and should consult their regulatory counsel about how best to proceed based on these announcements. The experienced FDA team at Buchanan Ingersoll & Rooney can assist any companies that have questions regarding this new policy.
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