SHalasey BBB_1136_crop100x100pSometime after the beginning of next month, FDA will publish a long-anticipated framework for the regulation of clinical diagnostics designed, manufactured, and used within a single laboratory—so-called laboratory-developed tests (LDTs).

Adoption of the proposed rules will bring an end to FDA’s long-held policy of “enforcement discretion,” under which the agency repeatedly asserted its statutory authority to regulate testing performed in clinical laboratories, even though it declined to do so. The agency’s claim to such authority has been under dispute for more than a decade, and appears no less controversial in its latest incarnation.

In a July 31 notification to Congress, FDA provided 60-day advance notice of its intent to publish the proposed guidance document. The notification described the agency’s proposal for a risk-based approach to regulating LDTs, including continued enforcement discretion for low-risk tests, but imposition of premarket approval (PMA) requirements for high-risk tests. Full implementation of the guidance will be phased-in over 9 years.

Manufacturers of in vitro diagnostics view FDA regulation as a means of leveling the playing field with labs that offer competing LDTs. “These types of tests are increasingly being used to diagnose and guide the treatment of potentially life-threatening conditions,” commented Andrew Fish, JD, executive director of industry association AdvaMedDx. “FDA oversight of higher risk diagnostic tests including companion diagnostics, regardless of the manufacturer, is essential to patient safety.”

Laboratory associations viewed FDA’s notification somewhat differently. The Association for Molecular Pathology (AMP) reaffirmed its position that laboratory testing should be considered a medical service rather than a product—laboratory-developed procedures, rather than laboratory-developed tests—and should therefore not be subject to FDA premarket review. Instead, AMP wrote, such operations should continue under the regulation of the Clinical Laboratory Improvement Amendments (CLIA) program at the Centers for Medicare & Medicaid Services.

For its part, the American Clinical Laboratory Association (ACLA) agreed that FDA should not displace CLIA. “To the extent that stakeholders have concerns about possible regulatory gaps under CLIA, ACLA has long supported enhancing the CLIA regulatory framework, rather than imposing an additional layer of regulation based upon a different statute designed for manufactured products rather than laboratory testing,” said Alan Mertz, ACLA president.

Whatever its final disposition, FDA’s proposal to regulate LDTs will have an impact on the clinical laboratory community for years into the future. Stakeholders should take full advantage of the formal comment period—including a planned public meeting—which will open when the guidance has been published in the Federal Register.

Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199