The agency should have gone for a notice of proposed rulemaking instead of a draft guidance when it comes to its oversight of laboratory-developed tests.
By Jim Dickinson
In its pending Framework for Regulatory Oversight for Laboratory Developed Tests (LDTs), FDA is making an audacious and potentially futile power grab.
Futile because however justified by public health concerns, the vehicle the agency has chosen is the legally vulnerable guidance document. Like anything FDA says publicly as an institution, the content of guidance documents is there to be weighed, interpreted, and tested in diverse forums (including courtrooms).
Moreover, the content is currently devoid of regulatory force. Every FDA guidance bears on its first page a boldly boxed statement saying it...