As we move through 2025, FDA medical device inspections are revealing a clear shift in regulatory posture under the current administration. While modernization and efficiency remain central themes, the FDA’s inspection strategy has become more targeted, more data-driven, and more unforgiving of systemic compliance gaps.

This alert outlines the key trends we’re seeing so far in 2025, how they compare to expectations, and what manufacturers must do to stay ahead.

Warning letters are more frequent—and more strategic

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the year—a rare pause that coincided with leadership changes and strategic recalibr

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