In the News

Since FDA announced in late 2016 that it would not finalize its laboratory developed test (LDT) guidances, it has become clear that any change to the LDT regulatory framework (at least during this administration) would need to come through a statutory change.  The first such proposal came in early 2017 with the release of the Diagnostic Accuracy and Innovation Act (DAIA).  FDA provided Technical Assistance (TA) on the DAIA last summer (see our earlier posts here and here).  As noted in our posts, FDA’s TA was essentially a complete rewrite of the DAIA, and the changes were viewed negatively by many in the industry.

It appears Congress had the opposite reaction, however. Last month, Chairman Walden, Ranking Member Pallone, Representative Bucshon, and Representative DeGette released a discussion draft of The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2018.  The VALID Act incorporates many concepts of FDA’s TA.  Congress is currently soliciting feedback on the draft through February 15, 2019.

While we do not expect that the discussion draft will be finalized in anything like its current form, we thought our readers would be interested in reading a short summary of the draft bill to understand the revised framework as it is radically different from what IVD manufacturers and labs are operating under today.  Our summary can be found here.  We encourage those with a stake in this legislation to contact their legislators, trade organizations, or other groups to provide feedback to this draft.  If finalized, this legislation could profoundly affect the availability and innovation of diagnostic tests.

We would also note that the discussion draft contains explicit requests for feedback.  Some sections relating to critical topics, e.g., breakthrough IVDs, are blank placeholders, or are bracketed, e.g., transfer or sale of approval or the precertification program.

Finally, we would emphasize that in a bill this complicated, careful drafting is essential.  Even seemingly modest tweaks to the established but complex IVD regulatory universe can have large ramifications, and the draft bill is anything but a modest tweak.

Allyson B. Mullen & Jeffrey N. Gibbs
FDA Law Blog