The Past, Present And Future Of FDA Regulation Of LDTs
It has been more than two years since FDA notified Congress of its intention to issue draft guidance on a proposed regulatory framework for the oversight by FDA of laboratory developed tests (LDTs). The draft guidance was published on October 3, 2014, and FDA received a plethora of public comment until the comment period ended in February 2015.
It’s worthwhile to reflect on the history preceding FDA’s controversial guidance, assess the current status of FDA enforcement, and offer our own guidance on how to prepare for eventual FDA enforcement to companies marketing high-risk LDTs.
It’s worthwhile to reflect on the history preceding FDA’s controversial guidance, assess the current status of FDA enforcement, and offer our own guidance on how to prepare for eventual FDA enforcement to companies marketing high-risk LDTs.