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The proposed rule is aimed at ensuring the safety and effectiveness of the tests.
FDA announced a new proposed rule for laboratory developed tests (LDTs) which is aimed at ensuring their safety and effectiveness.
The new proposed rule would amend current regulations and make it explicit that IVDs (under which LDTs are categorized) are devices that fall under the Federal Food, Drug, and Cosmetic Act. The rule would also grant the agency more oversight over LDTs.
In a press release, FDA commissioner Robert M. Califf, MD, said, “A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions. According to the Centers for Disease Control and Prevention, 70% of today's medical decisions depend on laboratory test results. Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health."
According to FDA, the reasoning behind this new rule is that modern LDTs have many more risks associated with them than LDTs of previous decades. One of the major concerns cited in the press release is the accuracy of these tests.
"Through increased FDA oversight, the public, including patients and health care professionals, should have confidence that the tests they rely on are accurate," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health in a press release. "It is important that these tests be held to the same standards as other tests, while helping to ensure test makers have the flexibilities they need to continue innovating and developing tests critical to the advancement of public health."
(Sept. 29, 2023); FDA; FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests; https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests