Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 12 December 2014 | By Alexander Gaffney, RAC,
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to regulate LDTs more like in vitro diagnostic testing products, in August 2014 FDA announced the release of a new draft guidance that would reverse what it called its “enforcement discretion” allowing LDTs to be regulated under CLIA.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.
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.”
A Modernized Framework for Innovative Diagnostic Tests
Tags: LDT, Lab Developed Tests, Laboratory Developed Tests, Congress, Energy and Commerce Committee, E&C, Whitepaper, White Paper
Regulatory Focus newsletters
All the biggest regulatory news and happenings.