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Today, the U.S. Food and Drug Administration (FDA) issued a Small Entity Compliance Guide (SECG) to assist small entities in complying with FDA regulations as they apply to in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs). The LDT final rule published on May 6, 2024, amends the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA finalized a policy under which the FDA will phase out its general enforcement discretion approach for LDTs over the course of four years so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. The phaseout includes targeted enforcement discretion policies for specific categories of IVDs manufactured by laboratories.
This SECG is intended to help small entities understand, in plain language, the LDT final rule, including the:
- Scope of the LDT final rule.
- Timing and compliance expectations of the phaseout policy described in the preamble to the LDT final rule.
- Applicability and compliance expectations of the targeted enforcement discretion policies for specific IVDs described in the preamble to the final LDT rule.
Questions?
If you have questions about this guide, contact LDTFinalRule@fda.hhs.gov.
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