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.