In recent years, concerns have been raised both inside and outside of the FDA about whether the current 510(k) program achieves its goals of making safe and effective medical devices available to the public while fostering innovation.
Concerns about the program have centered on whether it allows medical devices to enter the market without sufficient safety and effectiveness evidence and whether a lack of predictability, consistency, and transparency is hindering device development.
The FDA’s Center for Devices and Radiological Health (CDRH) uses science to guide its regulation of medical devices across the total product lifecycle.
CDRH assessment consists of two preliminary reports – one focuses on ways to strengthen and clarify a premarket review process called the 510(k) program for medical devices that do not need to undergo a full premarket approval review and, the other evaluates CDRH’s use of science in decision-making, with an eye toward adapting to new scientific information, while maintaining regulatory predictability necessary for innovation.
CDRH established two staff committees on these issues in late 2009 as part of its 2010 strategic plan. The committees collected and reviewed input from public meetings, open dockets, data analyses, and input from CDRH staff over the course of several months to prepare the complementary evaluations.
Jeffrey Shuren, director of CDRH, said: “Taken together, these preliminary reports show a smarter FDA – an agency that recognizes both sides of our mission to protect and promote public health. The agency is ready to make necessary improvements to support device innovation while assuring patients receive safe and effective devices.
“Even with our significant outreach, it’s important to remember that these recommendations are preliminary. CDRH opened another public docket to receive additional comments on both reports. We will make a decision on which recommendations to adopt only after a thorough review of additional comments.”
