Medical devices; Laboratory developed tests

Oct. 4, 2023
A proposed rule by the Food and Drug Administration on October 3, 2023.

The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.

In conjunction with this amendment, FDA is proposing a policy under which FDA intends to phase out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA is proposing this phaseout to better protect the public health by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.

Either electronic or written comments on the proposed rule must be submitted by December 4, 2023.

Read the proposed rule at the Federal Register

Read the proposed rule pdf

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