FDA joins consortium aiming to speed medical-device approval

The U.S. Food and Drug Administration has joined a public-private partnership called the Medical Device Innovation Consortium (MDIC), which it says will prioritize the regulatory science needs of the medical device community and fund projects to get devices to market more quickly.

The independent, nonprofit corporation MDIC was formed by LifeScience Alley, a Minneapolis-based biomedical science trade association.

"Advancements in regulatory science not only aim to improve how products are developed and evaluated, but also could reduce the cost and time takes for a promising device to come to market," the FDA said in an announcement. It cited an example of using a computer model to test an implant on a virtual patient before studying the product in a clinical trial.

The FDA said it may collaborate with the consortium on research and other projects.

"It really is going to represent a model that will be watched carefully, will be replicated. I know there will be real advances and new approaches that will emerge from it," FDA Commissioner Margaret Hamburg told reporters Monday, according to a report by Reuters.

Founding members of the consortium are Abiomed Inc., BD, Boston Scientific Corp., CVRx, Cyberonics Inc., Immucor Gamma, Medtronic Inc., Terumo BCT Inc., and the National Organization for Rare Disorders.

The FDA's involvement in the consortium comes a year after the agency issued a report called "Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health."

The framework detailed its efforts to improve its policies and practices in improving the safety and effectiveness of medical devices, according to an article by Pharmocogenomics Reporter. It came a year after the agency launched an initiative to improve its practices through regulatory science, according to the article.

To learn more:
- read the FDA announcement
- here's the Reuters article
- check out the FDA regulatory science framework
- here's the Pharmacogenomics Reporter article


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