According to a report released by the Institute of Medicine (IOM) Friday, the U.S. Food and Drug Administration needs to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. The 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one, concluded the committee that wrote the report.
The committee went further to say that FDA’s finite resources would be better invested in developing a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use.
Full details of the report are available at http://iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx