Summary
Amends U.S. Food and Drug Administration regulations to clarify that in vitro diagnostics, including those manufactured by laboratories, are devices under the FD&C Act; phases out general enforcement discretion and establishes staged compliance timelines over four years.
Healthcare Implications
Clinical laboratories and health systems must plan for registration/listing, quality system, and–where applicable–premarket review. AI‑assisted diagnostics using Laboratory Developed Tests should assess impact on validation evidence, labeling, and post‑market obligations.