Laboratory Developed Tests Regulatory Impact Analysis (Proposed Rule)

This proposed rule would, if finalized, amend 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.  This amendment would reflect FDA’s longstanding position that laboratory developed tests (LDTs) are subject to the device provisions of the FD&C Act.  This amendment would be accompanied by a change in FDA’s general enforcement discretion approach for LDTs that would phase out the approach for most LDTs, as discussed further in section VI of the proposed rule.

We quantify benefits to patients from averted health losses due to problematic IVDs offered as LDTs. Due to limitations in the data, we quantify health benefits only with respect to IVDs for certain diseases and conditions; however, we would expect additional health benefits associated with averted health losses for other diseases and conditions. Additional benefits would include averted non-health losses from the quantified reduction in costs of problematic IVDs offered as LDTs and unquantified reduction in costs from lawsuits and costs to healthcare systems. We quantify costs to affected laboratories for complying with applicable statutory and regulatory requirements. Additional costs would include some costs to FDA, which we include in our estimates. We estimate that the annualized benefits over 20 years would range from $2.67 billion to $86.01 billion at a 7 percent discount rate, with a primary estimate of $31.41 billion and from $1.81 billion to $61.41 billion at a 3 percent discount rate, with a primary estimate of $22.33 billion. The annualized costs would range from $2.52 billion to $19.45 billion at a 7 percent discount rate, with a primary estimate of $5.87 billion, and from $2.39 billion to $18.55 billion at a 3 percent discount rate, with a primary estimate of $5.60 billion. 

Regulatory Impact Analysis

Laboratory Developed Tests Regulatory Impact Analysis (Proposed Rule) (PDF-1.30 MB)

Federal Register: 88 FR 68006
Publication Date: 10/3/2023 
Docket: FDA-2023-N-2177