The Verifying Accurate Leading-edge IVCT Development (VALID) Act seems poised for passage in 2022, a bit of welcome relief for those stuck in the regulatory twilight world of the lab-developed test (LDT). However, Carly McWilliams, director of regulatory policy for North America for Roche Inc., said recently at the recent Food and Drug Law Institute enforcement meeting that the VALID Act is likely to leave the question of a user fee schedule for a future Congress, given that the associated rulemaking, guidance development and compliance activities are likely to consume the better part of, if not the entirety of, the next five years.