United States:
FDA Proposes Phased Approach To Regulating Laboratory Developed Tests
02 October 2023
Goodwin Procter LLP
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On September 29, 2023, the U.S. Food and Drug Administration
(FDA) posted and scheduled for publication its long-awaited proposed rule concerning FDA
regulation of laboratory developed tests (LDTs). If enacted, the
proposed rule would amend the Agency's regulations to make
explicit that in vitro diagnostic products (IVDs) are devices under
the Federal Food, Drug, and Cosmetic Act; and this includes when
the manufacturer of the IVD is a laboratory.
Upon finalization of the rule, FDA proposes to phase out its
general "enforcement discretion" approach for LDTs so
that tests manufactured by a laboratory would generally fall under
the same enforcement approach as other IVDs.
Comments to the proposed rule are due 60 days after the date of
publication of the proposed rule in the Federal Register. We will
provide our full analysis of the proposed rule in the coming
days.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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