The United States Food and Drug Administration announced a new partnership to enhance the development of regulatory approval protocols. The new public-private partnership is designed to reduce wait times and improve patient access to the latest advances in medical device technology.
According to a press release by the FDA, the new partnership will be with the Medical Device Innovation Consortium (MDIC). MDIC is a nonprofit corporation that was started by LifeSciences Alley (LSA). LSA is a trade association for the biomedical science industry. The nonprofit corporation by LSA will receive input from government, industry and other nonprofit groups. With this input, the MDIC will be able to prioritize the development of regulatory science.
Regulatory science describes the research processes used to develop medical device standards, minimum quality levels, device material regulations, evaluation protocols and much more. In addition, the MDIC will improve regulatory science by reducing the time and cost of bringing a new type of medical technology to the market.
With the MDIC, regulatory groups in the United States will be able to pool funding, people, ideas and resources to spur the development of new models, tools and methods that can be used to quickly and efficiency evaluate new medical devices. The FDA may collaborate with the MDIC on this and other initiatives related to regulatory science.
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