FDA Releases Medical Device Innovation Initiative
It’s about time.
According to the FDA website, “… The Center for Devices and Radiological Health (CDRH) is taking new steps to expand its current efforts to foster the development of safe and effective medical devices through a variety of initiatives and regulatory process improvements … This initiative includes the following efforts:
* Promoting scientific innovation in product development (Provide Regulatory Clarity Through Guidance Development, Invest in the Critical Path, Conduct Stakeholder Outreach and Improving Communications);
* Focusing device research on cutting edge science (Laboratory Research to Support Efforts to Improve the Device Development Process);
* Modernizing review of innovative devices (Implement a Quality Review Program, Provide Clarity Through Guidance Development, Leverage Information Technology Solutions, Expand Clinical and Scientific Expertise at FDA)”
A link to the full statement can be found at www.fda.gov.