 
“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.
Laboratory developed tests, or LDTs, play an important role in healthcare. LDTs are in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single clinical laboratory which meets certain laboratory requirements.
Today, the U.S. Food and Drug Administration (FDA) announced this proposed rule: Medical Devices; Laboratory Tests. The proposed rule seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a policy under which the FDA intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach to LDTs.
Note: This proposed rule is not for implementation at this time.
Submit comments on this proposed rule
Submit comments under docket number FDA-2023-N-2177 at www.regulations.gov between October 2, 2023 and December 1, 2023 to ensure the FDA considers comments on this proposed rule before it begins work on the final version of the rule.
Questions?
If you have questions about this proposed rule, contact the Division of Industry and Consumer Education.
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