FDA works to improve science used to approve medical devices (press release)
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) today released a report highlighting scientific activities that support the medical device industry and product development, while maintaining the safety and effectiveness of the products.
The report, "Regulatory Science in FDA’s Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health,” offers a look at the work FDA engages in every day to help foster science that enables and supports innovation and sound medical product development.
“The regulatory science plan provides an informative and transparent look at the work we conduct in collaboration with industry and academia to facilitate the development, assessment, review, and manufacturing of medical devices that will benefit patients more quickly and at a lower cost to industry,” said William Maisel, M.D., deputy director and chief scientist at CDRH.
Regulatory science efforts cited in the report range from providing device designers with computer modeling of cardiovascular devices to developing standard tests for...
