BioCentury
ARTICLE | Regulation

The U.S. needs a dedicated medical products regulator

Back to School 2025: The case for breaking FDA into manageable pieces, starting with a medical products regulatory agency

August 13, 2025 12:52 AM UTC

To equip the FDA for the challenges and opportunities of the 21st century, the agency should be restructured into smaller, more focused entities that are nimble enough to avoid bureaucratic paralysis and independent enough to resist political interference in regulatory decisions.

One of these agencies should focus exclusively on medical products: drugs, biologics, devices and diagnostics...