On November 17, 2015, the Committee on Energy and Commerce, Subcommittee on Health, held a hearing focusing on draft proposed legislation supporting a new regulatory framework for in vitro clinical tests that would comprise a new category under the Federal Food, Drug, and Cosmetic Act. Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health, US Food and Drug Administration (FDA) provided testimony supporting the FDA’s position that all laboratory diagnostic tests (LDTs) should be regulated under the FDA’s existing risk-based regulatory framework for medical devices. Currently, the FDA only exercises discretion in reviewing LDTs for clinical validity prior to marketing. Likewise, the Centers for Medicare & Medicaid Services (CMS) does not ensure the validity of laboratory testing, but rather ensures proper policies, procedures, and personnel.

The FDA proposes phasing in enforcement of premarket review requirements for higher-risk LDTs (e.g., LDTs intended to guide treatment decisions). While the FDA currently exercises discretion concerning premarket evaluation for all LDTs, the FDA proposes to continue exercising its enforcement discretion only with respect to low-risk LDTs and LDTs for certain rare diseases. The FDA estimates that fifty percent (50%) of all LDTs will be considered low risk, and therefore subject to the lower threshold of the FDA’s enforcement discretion. The FDA also provides clinical laboratories with the option of notifying the FDA of LDTs that they manufacture, in lieu of registration and listing.

In support of the FDA’s proposals, Dr. Shuren emphasized in his testimony that both LDTs and in vitro Diagnostic Devices (IVDs) have the same potential uses in health care (e.g., diagnosing conditions, directing a course of treatment, and managing disease). The FDA currently regulates IVDs under its flexible, risk-based framework applicable to medical devices, but does not currently regulate LDTs under this same framework. But, as Dr. Shuren noted, LDTs have transformed from relatively simple to highly complex tests in recent years, thus triggering the need for more extensive oversight.

In further support of the FDA’s proposals, Dr. Shuren highlighted the negative implications for patients resulting from incorrect results obtained from faulty clinical laboratory tests. For example, many ovarian cancer tests are developed by laboratories without proper validation, and these tests produce high numbers of false-positive results. Women who receive false-positive results may undergo extensive and medically unnecessary surgery as a result of these faulty test results. Because of the real public health risk associated with faulty laboratory results, the FDA believes a more proactive oversight policy for LDTs is necessary. The FDA hopes to adopt a flexible approach to enable laboratories to come into compliance, and anticipates extensive collaboration with CMS to ensure proper oversight of laboratory practices and testing.

The full hearing is available for viewing here.

*Blake Walsh is admitted only in Tennessee. Her practice is supervised by principals of the firm admitted in the District of Columbia.