A report which outlines scientific activities that endorse product development as well as the medical device industry, while maintaining the efficiency and safety of products was released this week by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH)

The study, “Regulatory Science in FDA’s Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health,” provides insight into the work the FDA takes on each day in order to help support science that allows and supports novel and sound development of medical products.

William Maisel, M.D., deputy director and principal researcher at CDRH, explained:

“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.”

Regulatory science efforts mentioned in the study range from creating standard tests for the performance and durability of spinal disc implants to giving device designers with computer modeling of cardiovascular devices. The report was created in order to give, investigators, clinicians, the medical device industry and patient groups an insight into the wide range of scientific activities at the Center for Devices and Radiological Health, as well as how they support new devices and protect the health of the public.

Funding for regulatory science assists in maintaining a strong medical device industry as it reduces the time and resources required in order to develop, examine and test new products. This can result in faster and more effective approvals of devices, possibly reducing the amount of time and size of pre-market clinical trials, as well as speeding up the rate in which these novel technologies come to market.

The FDA remains focused on improving their regulatory science abilities in hope of new medical product applications that are increasingly complicated and that often include novel technologies into their design and manufacture.

Maisel, explains:

“This report provides evidence of the FDA’s commitment to evolving the methodology and science it uses to review products to keep pace with the rapid progression of the science used in product development.”

In August, the FDA released its “Strategic Plan for Regulatory Science.” That plan touches on several priority areas identified in greater detail in CDRH’s regulatory science report.

Written by Grace Rattue