Medical Product Development Tools at FDA
As part of its mission to protect public health and promote innovation, FDA helps medical product developers translate discoveries in basic science into safe and effective new therapies that save lives and improve health care.
One important way that FDA does this is by advancing the tools, methods, and models used to develop medical products, which reduces the time, complexity, and cost of their development, while maintaining patient protections. This effort enables patients’ faster access to life-improving and life-saving medicines, biologics, and devices.
FDA culled the following resources from across its web site, which can be leveraged to further the use of these tools in medical product development.
- Personalized Medicine
- Biomarkers at FDA
- BEST (Biomarkers, Endpoints, and other Tools) Resource. This resource was developed by an NIH-FDA joint team in response to a need to harmonize terms used in translational science and medical product development. The first phase of BEST comprises a glossary that clarifies important definitions and describes some of the hierarchical relationships, connections and dependencies among the terms it contains. NIH and FDA intend to use the definitions included in this glossary when communicating on topics related to its contents (e.g. biomarkers) to ensure a consistent use of the terms and therefore, a common understanding of the issues.
- BEST Resource Fact Sheet
- Drug Development Tools (DDT) Qualification Programs
- In Vitro Diagnostics
- Laboratory Developed Tests
- Companion Diagnostics
- Medical Device Development Tools (MDDT)
* Note: this is not an all-inclusive list of FDA guidance documents on this topic. Additional guidance documents can be found using the guidance document search.