Health Advocates, Lobbyists Watching Fate Of FDA-Issued Regulations On LDTs Closely

MedPage Today (1/10, Frieden) reported, “As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health advocates and lobbyists will be watching closely.” LDTs are “clinical tests developed by individual labs in doctors’ offices and hospitals to be used in patient care.” Last spring, “the FDA finalized regulations...to further oversee LDTs.” According to MedPage Today, “tests that fall under the FDA’s final rule – unless they are specifically exempt – would need to go through either a 510(k) clearance process or FDA premarket approval before the labs could start using them.” But, “many of the tests that laboratories were using before the rule came out will be exempt from the regulations, noted Bruce Quinn, MD, PhD, a health policy consultant.”