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  1. Economic Impact Analyses of FDA Regulations

Laboratory Developed Tests Regulatory Impact Analysis (Final Rule)

This final rule amends FDA’s regulations in part 809 (21 CFR part 809) to make explicit that “in vitro diagnostic products” (IVDs) are devices as defined in section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h)(1)) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs, as discussed further in section V of the preamble to the rule. 

We quantify benefits to patients from averted health losses due to problematic IVDs offered as LDTs.1,2 We focus mainly on certain broad disease categories associated with the majority of misdiagnosis-related harms in the U.S. Additional benefits include averted non-health losses from reduced spending on problematic IVDs offered as LDTs and unquantified reduction in costs from lawsuits. We quantify costs to affected laboratories for complying with statutory and regulatory requirements, as described in the phaseout policy. Additional costs include costs to FDA, which we include in our estimates. We estimate that the annualized benefits over 20 years range from $0.99 billion to $11.1 billion at a seven percent discount rate, with a primary estimate of $3.51 billion, and from $1.24 billion to $13.62 billion at a three percent discount rate, with a primary estimate of $4.34 billion. The annualized costs range from $566 million to $3.56 billion at a seven percent discount rate, with a primary estimate of $1.29 billion, and from $603 million to $3.79 billion at a three percent discount rate, with a primary estimate of $1.37 billion.

Regulatory Impact Analysis

Laboratory Developed Tests Regulatory Impact Analysis (Final Rule) (PDF-1.5MB)

Federal Register: 89 FR 37286
Publication Date: 5/6/2024
Docket: FDA-2023-N-2177

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