Laboratory-Developed Tests: A Legislative and Regulatory Review

Area of Science:

• Regulatory science
• In vitro diagnostics
• Clinical laboratory operations

Background:

• The Food and Drug Administration (FDA) has long considered laboratory-developed tests (LDTs) subject to regulatory oversight.
• A 2014 draft guidance on LDT oversight sparked debate, but remains unimplemented, leaving regulatory questions unresolved.

Purpose of the Study:

• To review federal statutes and regulations pertinent to in vitro diagnostics (IVDs) and clinical laboratory operations.
• To analyze regulatory efforts potentially applicable to LDTs and identify sources of community uncertainty.

Main Methods:

• Review of federal statutes and regulations (Code of Federal Regulations, Federal Register).
• Analysis of congressional hearings, FDA guidance and policy documents, and published literature.

Main Results:

• Federal IVD statutes predate explicit consideration of LDTs.
• The FDA possesses clear oversight authority over IVD reagents in commerce.
• A 16-year delay in asserting authority, draft guidance, and CLIA'88 regulations created uncertainty regarding LDT oversight.

Conclusions:

• Existing federal statutes were enacted without specific consideration for LDTs.
• FDA's historical approach and existing regulations have contributed to ambiguity in LDT oversight.
• Future regulatory or legislative action may be necessary to clarify LDT oversight.