After Congress’s most recent failure to pass legislation that would have imposed clear FDA regulation of laboratory-developed tests (LDTs), the FDA indicated it would not wait for the government to settle the matter.
As explored in a recent G2 Intelligence Diagnostic Testing & Emerging Technologies (DTET) article, the agency followed up those comments with action when it submitted its own proposed LDTs rule to the White House Office of Information and Regulatory Affairs at the end of July.
Though the FDA “has exercised de facto oversight of LDTs,” there are no official regulations governing LDTs, and whether the FDA has authority to regulate these tests is unclear, says the article. However, the use of LDTs has expanded greatly in recent years, making clear regulation critical to ensuring these products are safe and effective.
The Verifying Accurate Leading-edge IVCT Development (VALID) Act that would create a risk-based process for FDA approval of LDTs is back on the table in Congress. Though it could pass and make the FDA’s proposed rule moot, the agency’s option could potentially ensure the LDTs matter is settled sooner if VALID fails to pass again.
Though the finer details of the FDA’s proposed rule haven’t been made public yet, five of seven scheduled meetings regarding the rule have been completed, with the sixth meeting scheduled for this afternoon. The information that has been released states that the rule, if adopted, would tweak the FDA’s regulations “to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.”
To read the full article, “The Diagnostics Pipeline: FDA Proceeds without Congress Over LDTs Reform,” sign in to your DTET subscription or sign up for a free trial.