This whitepaper will explore the role the FDA has played, and will continue to play, in regulating in vitro diagnostic devices. It will examine the three groups of in vitro diagnostic devices: Analyte Specific Reagents (ASRs), Laboratory Developed Tests (LDTs) and In Vitro Diagnostic Devices (IVDs).
We will examine the role IVDs have played in blurring the traditional lines between device and drug.
Finally, the important role of IVDs in medicine in the 21st century will be discussed as health care shifts away from a model of “one size fits all.”
Complete the form to read more about In Vitro Diagnostics.