August 4, 2011
On July 29, 2011, The Institute of Medicine (IOM) released a report recommending substantial changes to the FDA’s 510 (k) approval process for devices.Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process, named for Section 510(k)of the FFDCA. A few policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective. Other policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market.
IOM concluded that the 510(K) process is flawed and that the FDA’s resources would be better used creating an integrating a pre and post market regulatory framework that provides reasonable assurance during the lifecycle of the device.
For more information and to review the report, please click on the following: http://iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx