Significantly neither FDA, industry groups, nor any other entity has an educated guess on how prevalent the use of RUO and IUO products is within laboratory developed tests (LDTs).

WASHINGTON, DC, August 30, 2011—The Association for Molecular Pathology (AMP) submitted comments to the US Food and Drug Administration on the draft guidance document titled, "Commercially ...

While FDA has long made it clear that companies could not promote RUO and IUO products for diagnostic uses, the agency had never laid out specific parameters. The draft guidance document helps ...

"The selected nutrients and the nutrient levels required for eligibility vary among the different symbol programs in use. With the increasingly widespread availability of these symbols from ...

The Medical Testing Availability Act of 2015 would restrict the ability of the FDA to enforce tacit marketing of "research use only" diagnostics for clinical purposes. The bill is sponsored by Rep ...