The Verifying Accurate Leading-edge IVCT Development (VALID) Act has been floating around Capitol Hill for the past four years, but was once again left by the wayside when Congress passed the latest round of U.S. FDA user fee legislation. Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said in a press briefing that the prospects for the legislation dim considerably if Congress does not pass the VALID Act by the end of the calendar year, raising the prospect that the FDA will act unilaterally to engage in rulemaking to deal with regulation of lab-developed tests.