As noted today on the Hyman Phelps FDA Law Blog (here), an emerging coalition called the Diagnostic Test Working Group has released a broad plan to up-end the way FDA regulates diagnostics. If enacted by Congress, the FDA, CMS, and states would undertake a very substantial revamping (including changes in law) of FDA's governance of diagnostics.
Details are on the Personalized Medicine Coalition website (here); see also my cloud archive - executive summary, here; full white paper, here; one pager, here.
The proposal would leave diagnostic test design and validation in the hands of the FDA, but would extend this authority for both IVD (kit-distributed) and LDT diagnostics. Once the test is designed and validated, operations to run the test would be in the hands of CLIA (or its designated examining agencies). Unusually, the proposal leaves much of the claims and sign-out authority in the hands of the states.
For those with subscription access, see Genomeweb, "Small Group of Labs, Dx Manufacturers Float Alternative to FDA LDT Guidance" - here, which comments the Hyman Phelps blog. See also "Coalition of Manufacturers, Labs Floats Alternative to LDT Approach" at Inside Health Policy, here.
FDA and CMS announce "Task Force" on LDT Quality
Webpage announcement here, at Blogs.FDA.gov. Co-authored by Jeff Shuren (FDA) and Patrick Conway (CMS), the agencies describe some stakeholder confusion in the wake of the FDA's plan to regulate LDTs under FDA law but in a phased-in fashion. The two-agency "task force" will
...Establish an interagency task force that will continue and expand on our collaboration related to the oversight of LDTs, which are tests intended for clinical use and designed, manufactured, and used within a single lab. The task force, comprised of leaders and subject matter experts from each agency, will work to address a range of issues, including those involving quality requirements for LDTs.
Of course, this is a poke in the eye to those stakeholders who felt that CLIA already enforced the quality of laboratory developed tests.
More analysis and insight on these topics, to follow....