On November 17, 2015, the US House of Representatives Committee on Energy and Commerce, Subcommittee on Health will hold a hearing entitled “Examining the Regulation of Diagnostic Tests and Laboratory Operations.”  The focus of the hearing will be a 185-page draft of proposed legislation to establish a new regulatory framework for “in vitro clinical tests” or IVCTs.

The hearing will include testimony from officials from the Food and Drug Administration and the Centers for Medicare and Medicaid Services (CMS), who will speak about the current and potential future role of each agency with respect to regulation of diagnostic testing.   

The draft was produced by a working group comprising several clinical laboratories and in vitro diagnostic (IVD) device manufacturers. The group formed following FDA’s issuance, in October 2014, of two draft guidance documents that propose a fundamental shift in the agency’s regulation of laboratory developed tests (LDTs). Whereas FDA has historically not regulated the activities of most clinical laboratories, the draft guidance proposes to regulate all LDTs as medical devices using the agency’s existing regulatory framework for medical devices.  FDA’s draft guidance documents garnered more than 100 comments, many of which raised concerns about the proposed framework’s impact on clinical laboratory testing, while some, including those of AdvaMed, supported FDA’s approach.

The stated goal of the proposed legislation is to “advance innovation for patient benefit, protect patients, provide a predictable and timely path to market, ensure reasonable risk-based regulation, avoid duplicative regulation, advance precision medicine, and apply the same regulatory principles to the same activity regardless of entity type.”  Key features of the proposal include:

  • Creating a single product category, the IVCT, that includes both IVD test kits sold by device manufacturers and LDTs developed in-house by clinical laboratories, and thereby removes both IVDs and LDTs from regulation as medical devices and eliminates  the current bifurcated approach to IVD and LDT regulation
  • Establishing a new Center for In Vitro Clinical Tests within the FDA, which would be responsible for establishing a risk-based classification system for IVCTs 
  • Directing FDA to establish advisory panels consisting of persons “with knowledge of in vitro clinical tests, laboratory operations, and the use of in vitro clinical tests” to review and consider the classification of IVCTs
  • Directing FDA to use third-party review for moderate-risk IVCTs and streamlining the review process for such products
  • Providing for “deemed” approval of low-risk IVCTs based only on manufacturer notification to the agency
  • Creating alternative, expedited review pathways for IVCTs for rare diseases, unmet needs, or emergency use and
  • Limiting full FDA premarket review to high-risk IVCTs, defined as those tests in which a “clinically significant inaccurate result for the intended use of the test would cause serious or irreversible harm, or death, to the patient or public based on the failure to treat, incorrect treatment, invasive procedures, or prolonged disability if such inaccurate result were undetected when used as intended in medical practice.”

Some proponents view the proposed legislation as a means to head off FDA’s issuance of a final LDT guidance and resolve the longstanding uncertainty surrounding FDA oversight of LDTs. Both clinical laboratories and IVD manufacturers may want to consider the implications of the proposed bill for their companies.  

The draft bill may be found here.