Impact of New Executive Orders on FDA’s Medical Device and AI Regulations

Recently, the new administration released executive orders signed by US President Donald Trump that may impact the FDA’s oversight of medical devices and digital health products. Key points include:

Regulatory Freeze: A new executive order halts the FDA from issuing or proposing new rules until reviewed and approved by an appointed agency head. This could delay rulemaking for device classifications and other FDA regulations, such as updates to quality system rules.
Impact on AI Policies: Trump’s order rescinds a prior executive order by President Biden that outlined AI oversight across government agencies, including the FDA. This will affect FDA guidance on AI-enabled medical devices and may require updates to definitions and resources used in AI-related FDA policies.

These executive actions may lead to regulatory delays and uncertainty, especially regarding AI-related guidance and global initiatives.
Withdrawal from the WHO: Another executive order removes the US from the World Health Organization, which could affect FDA initiatives involving WHO collaboration, like the Medical Device Single Audit Program and the International Medical Device Regulators Forum.

Read the full regulation review here.