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Califf Hints at FDA Diagnostics Changes if Congress Fails to Act

Oct. 25, 2022, 7:41 PM

The FDA may pursue changes to how it regulates diagnostic tests if Congress doesn’t include related legislation in an end-of-year spending package, agency chief Robert M. Califf said Tuesday.

“Federal rulemaking” is “always an option for the FDA,” Califf said when asked about the Verifying Accurate Leading-Edge IVCT Development, or VALID, Act during a fireside chat at the Advanced Medical Technology Association’s annual conference in Boston.

He added that proposing and finalizing a rule is “a very lengthy and contentious process,” and that the changes sought in the VALID Act would be much better suited for legislative passage.

The VALID ...