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  1. CDRH Reports

CDRH Plan of Action for 510(k) and Science

Implementation of Recommendations from the 510(k) and Science Reports

The links below provide information on steps CDRH is taking to foster medical device innovation and assure the safety and effectiveness of medical technologies used in the United States.

The Summary and Overview of Comments and Next Steps below describes which recommendations from the August 2010 reports on the 510(k) program and CDRH's use of science in its decision-making we will implement.

The Summary is accompanied by a Plan of Action, which outlines 25 specific actions and accompanying timelines for completion or for reaching a milestone in 2011. These actions will make the 510(k) program a blueprint for smarter medical device oversight; one that drives innovation and brings important technologies to patients.

Overview of FDA Actions

Information on Improving Premarket Programs

Guidance, Regulation, and Standard Operating Procedures

CDRH Center Science Council (CSC)

The CSC provides oversight of the Center’s science programmatic functions and helps share knowledge throughout the Center, consistent with CDRH’s other ongoing efforts to improve internal communication, consistency, transparency, and quality in scientific decision making, and predictability of regulatory pathways and requirements.

Network of Experts

The Food and Drug Administration (FDA) is announcing the availability of the standard operating procedure (SOP) for “Network of Experts.” The SOP describes the Center for Devices and Radiological Health’s (CDRH) process to provide CDRH staff with rapid access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise within the Center.

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