Shuren In The Lion’s Den: Device Center Chief Defends LDT Plan At Clinical Lab Meeting, Fields Wide Array Of Questions
This article was originally published in The Gray Sheet
FDA device center Director Jeff Shuren explained and defended fine points of FDA’s proposed laboratory-developed test framework before some of his sharpest critics: members of the American Clinical Laboratory Association, who face an entirely new regulatory scheme once the LDT proposal is finalized.
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Lawmakers are circulating draft legislation that would create a new regulatory category, distinct from medical devices, combining in vitro diagnostics and laboratory-developed tests. The representatives say they don't have specific timing in mind for moving the bill forward. But it is being circulated just as the FDA user-fee reauthorization process is getting off the ground, presenting a possible legislative vehicle.
Republican Congress, Trump Policies May Seek To 'Undo' FDA Device Safety Guidances; LDT Plan First To Go
Emboldened by a Republican victory in the White House, GOP members of Congress are already putting the screws on federal agencies to back off on health and safety regulations and guidances for products, with some success – for example, FDA's Nov. 18 decision to shelve its proposed laboratory developed test guidance in final form seems to be a response to the new political reality in DC.
After years of wrangling over lab-developed test regulations with laboratory lobbyists, FDA has put its plans to finalize a guidance that lays out its oversight framework for LDTs on hold as a new Congress and a new deregulation-focused president-elect is set to take the helm.