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May 22: FDA Announces Initiative to Facilitate the Development and Availability of Medical Devices

The U.S. Food and Drug Administration (FDA) is launching the Medical Device Innovation Initiative to make new medical devices available more quickly for patients. This broad initiative will promote early interaction between the FDA and industry to optimize review times and foster innovation. As outlined in a report released by the Agency today, the Center for Devices and Radiological Health (CDRH) will expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least burdensome approach to clinical trials. This initiative builds on CDRH's strong scientific foundation and additional resources for the device review program provided under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

As part of this initiative, FDA also announced today a critical step forward in modernizing the medical device development process by issuing new guidelines to outline the use of adaptive clinical trial designs. The draft guidance titled, "Bayesian Statistics in Medical Device Clinical Trials", provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. "Although this guidance is not yet final, it is a very exciting move in the direction of expediting new technology to the public," said CDRH Director Daniel Schultz, M.D. The use of Bayesian statistics offers industry the option of using prior, legally available information about safety and/or effectiveness in a mathematically acceptable way to design more efficient clinical trials, while still maintaining scientific rigor. Depending on the type of data available, this may lead to shorter, less expensive clinical trials.

For complete FDA report of this update, please refer to following links:
http://www.fda.gov/cdrh/ocd/mdii.html
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01377.html

If you have comments regarding this update, please email us at info@mdiconsultants.com

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