It has been estimated that In Vitro Diagnostics (IVD) will play a role in around 70% of health care decisions, and market estimates predict the IVD market will be close to 75 billion dollars in 2010. The role of IVDs in health care decisions should only continue to grow as healthcare shifts away from a “one-size-fits-all” model. Furthermore, developments in technology and the scope and precision of some of these devices have led to the evolution of the IVD field and with it, the role the FDA has played in regulating these devices.
The purpose of this whitepaper is to explore this evolution and the role the FDA has played, and will continue to play, in regulating in vitro diagnostic devices. To explore this, we have evaluated three groups of in vitro diagnostic devices:
- Analyte Specific Reagents (ASRs)
- Laboratory Developed Tests (LDTs)
- In Vitro Diagnostic Devices (IVDs)
Beyond these three groups, it is also evident that In Vitro Diagnostic devices will continue to blur the traditional line between drug and device. This line will only continue to blur as these devices move into the center of confluence within a personalized medicine approach to healthcare. However, with this increasingly important role comes the need for continued research, development, and oversight of trials for these devices in order to ensure the promises they offer are delivered. Furthermore, it will also require continued reassessment of the regulations as they evolve.
Please take time to download IMARC’s whitepaper and share your thoughts.