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Published on: June 27, 2014
Creating a space for innovative device development
Michelle McMurry-Heath1, Margaret A Hamburg
1Office of the Center Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA. michelle.mcmurryheath@fda.hhs.gov
Science Translational Medicine
|December 5, 2012
Summary
The U.S. Food and Drug Administration (FDA) is partnering with the Medical Device Innovation Consortium to improve regulatory science for medical technologies.
Area of Science:
- Regulatory science
- Medical technology innovation
Background:
- The medical device landscape is rapidly evolving.
- Advancing regulatory science is crucial for ensuring patient safety and access to innovative medical technologies.
Purpose of the Study:
- To announce a strategic partnership between the FDA and the Medical Device Innovation Consortium.
- To foster collaboration aimed at enhancing regulatory science within the medical technology sector.
Main Methods:
- Establishment of a new nonprofit organization: the Medical Device Innovation Consortium.
- Collaborative efforts between the FDA and the consortium to address regulatory challenges.
Main Results:
- A new public-private partnership is formed.
- Initiatives to accelerate the development and review of novel medical devices are expected.
Conclusions:
- This partnership signifies a commitment to modernizing medical device regulation.
- The collaboration is poised to drive innovation and improve regulatory pathways for medical technologies.
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