fda_logo.gif cdrh1.gif



Term:
Medical Device Innovation Initiative


Description:
The Medical Device Innovation Initiative is an initiative fronted by the FDA or more specifically the CDRH that tries to push the latest technologies from the lab into clinical trials with effectiveness and safety at a low cost in order for the technology to reach the hands of the general public. The initiative also pushes to use the most cutting edge manufacturing methods from other industries for the manufacturing of medical devices which wouldn’t usually have been used in the medical industry.

The initiative is involved with trying to promote communication with industry and the FDA in order to expedite review times as well as offer a more nurturing environment for device innovation.

Applications:
• Promoting scientific innovation in the development of products
• Focusing device research on cutting edge science and manufacturing techniques
• Modernizing the review processes of innovative devices


Terminology:
FDA- an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.

CDRH- The Center for Devices and Radiological health is a branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.


Web Sources/Citation:
http://www.fda.gov/cdrh/ocd/mdii.html

http://lawprofessors.typepad.com/products_liability/2006/05/in_a_may_22_200.html

http://www.ivtconferences.com/IVTNews/templates/IVTNews.aspx?articleid=1393&zoneid=26