FDA update October 4, 2011

Report on Regulatory Science in FDA’s Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health

FDA works to improve science used to approve medical devices

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 FDA 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 cited in the report range from providing device designers with computer modeling of cardiovascular devices to developing standard tests for the durability and performance of spinal disc implants. The document is intended to give clinicians, researchers, patient groups and the medical device industry an idea of the scope of the scientific activities at CDRH and how they support device innovation and protect public health.

Investments in regulatory science help to maintain a robust medical device industry by reducing the time and resources needed to develop, assess and test new products. This can lead to quicker, more efficient device approvals, potentially decrease the size and duration of premarket clinical trials, and speed the rate at which breakthrough technologies reach the market. 

The FDA continues to focus on improving its regulatory science capabilities in anticipation of receiving applications for new medical products that are increasingly complex and that frequently incorporate new technologies into their manufacture and design.

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.

Any questions on this FDA guidance please email us at info@mdiconsultants.com and Ref: Regulatory Science in CDRH.

For more information on this guidance you can go to the following link: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM274162.pdf .