Califf Hints at FDA Diagnostics Changes if Congress Fails to Act

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 ...