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How Should Diagnostic Tests be Regulated? Congress Wants to Know

Posted 12 December 2014 | By Alexander Gaffney, RAC

How Should Diagnostic Tests be Regulated? Congress Wants to Know

A new white paper published by the House Energy and Commerce Committee is calling for feedback on the US Food and Drug Administration's (FDA) proposal to regulate laboratory developed tests (LDTs) more similarly to how they regulate in vitro diagnostics.


Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to the Clinical Laboratory Improvement Amendments (CLIA), a law intended to ensure laboratories and the testing conducted therein are held to acceptable standards.

In recent years, however, FDA regulators have expressed their view that LDTs have in some cases become complex enough to make them indistinguishable from FDA-approved or -cleared devices. Of particular concern to FDA is that some of the LDTs, such as genomic sequencing tests, are used to support or enhance clinical decision-making without having undergone a rigorous review of their efficacy or accuracy.

After years of indicating it intended to regulate LDTs more like in vitro diagnostic testing products, in August 2014 FDA announced the release of a new draft guidance that would reverse what it called its “enforcement discretion” allowing LDTs to be regulated under CLIA. Under the new regulatory paradigm, FDA would subject some LDTs—high-risk LDTs, in particular—to registration, listing, adverse event reporting and premarket review requirements.

While traditional medical device manufacturers greeted FDA’s LDT proposal favorably, LDT manufacturers (and some legislators) greeted it with scorn and threats. The policy, the latter said, would act as a deterrent to developing new innovative products capable of helping consumers. FDA's policy also violated the law, LDT groups alleged, and ought to have been promulgated as a proposed regulation—not a guidance. The group has also retained two extremely prominent attorneys, Paul Clement and Laurence Tribe, to represent their interests in the event that FDA's draft guidance is finalized.

For an extensive explanation of FDA’s proposed LDT policy, please read our explanation here.

Call for Comments

In light of the controversy surrounding the move, in November 2014 FDA announced it would hold a workshop in an attempt to collect public feedback. Among the factors it said it wanted public input on were the regulation of LDTs for rare diseases, whether LDTs used in certain settings might be subject to enforcement discretion, and how the phase-in of its new regulatory policy would occur.

Now Congress is inserting itself into the public comment process as well.

On 9 December 2014, the House Energy and Commerce Committee announced the release of a new whitepaper as part of its ongoing "21st Century Cures Initiative," which is expected to result in new legislation being filed in January 2015.

The paper, A Modernized Framework for Innovative Diagnostic Tests, raises 11 questions for discussion, all focused on FDA's proposed regulation of LDTs.

"We are aware that the agency’s release of the guidance documents has served as a catalyst for broader conversations about the overarching need to modernize governmental oversight of these unique and increasingly important medical products," the committee said in a statement on its website. "As the 21st Century Cures initiative proceeds, with preparations for a discussion draft early in the New Year, the committee appreciates all interested stakeholders’ specific feedback on the following questions by 5 January 2015, in addition to advice on what role Congress should play in addressing any other related issues.”

Congressional Questions

  1. Multiple stakeholders have expressed the urgent need to have clear and logical lines separating the practice of medicine, the actual conduct of a diagnostic test and the development and manufacturing of diagnostic tests. How should these lines be defined and what are the key criteria separating each of these activities?
  2. In FDA’s draft regulatory framework, the agency describes the extent to which it proposes to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FFDCA). It is relatively clear with respect to distributed test kits what constitutes a “device,” but less clear when considering a test developed and performed in a laboratory. What should comprise the “device” subject to regulation by the FDA?
  3. FDA intends its regulation of diagnostics to be risk-based. How should risk be defined? Are the types of risks posed by diagnostic tests different from therapeutic medical devices? Are these risks different with LDTs compared to distributed test kits? Is the traditional medical device classification system appropriate for these products?
  4. The current pre-market review standards that apply to in vitro diagnostics use the same terminology of safety and effectiveness that apply to all medical devices. Should the medical device concepts of safety and effectiveness apply to test kits and LDTs?
  5. Are there areas where the balance between pre-market review versus post-market controls should be reconsidered? How can post market processes be used to reduce barriers to patient access to new diagnostic tests?
  6. A number of stakeholders have expressed concerns about uncertainty as to when a supplemental premarket submission is required for a modification. When should they be required prior to implementing modifications? Should the requirements for submission of a supplemental clearance or approval differ between LDTs and distributed test kits?
  7. We have heard a lot about the practice of medicine and its relationship with medical product “labeling.” What should comprise “labeling” for diagnostic tests? Should different standards for dissemination of scientific information apply to diagnostic tests versus traditional medical devices? What about for laboratories that develop, perform, and improve these tests? Should there be regulatory oversight of the information that is provided to the individual patient or health care provider or is that the practice of medicine?
  8. The Section 1143 guidance documents raise important questions about the relationship between the FFDCA and the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services (CMS). Is there overlap between the requirements of the guidance documents and CLIA? For instance, how do FDA’s quality systems regulations compare with CLIA quality systems requirements? Are there areas of duplication where there would be efficiencies to having either CLIA or FDA regulate, rather than both?
  9. How should any regulatory system address diagnostic tests used for rare diseases or conditions, customized diagnostic tests and diagnostic tests needed for emergency or unmet needs (e.g. Ebola)?
  10. Any new regulatory system will create transition challenges. How should existing products be handled? Should all current diagnostic tests be “grandfathered” into the marketplace? What transition process should be used for new product introductions?
  11. What incentives can be put in place to encourage the development of new, more accurate or more efficient diagnostic tests?


A Modernized Framework for Innovative Diagnostic Tests

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