Implanted medical devices would require unique numerical identifiers under new legislation proposed by a group of US senators. A UDI program created almost 5 years ago has yet to be implemented by FDA. If the Ensuring Safe Medical Devices for Patients Act passes as proposed, FDA will be required to issue a final rule on unique device identification (UDI) by the end of 2012.
The new bill would also bring devices into FDA’s postmarketing surveillance program. Most devices that receive FDA clearance for marketing do not go through the premarket approval (PMA) process, which includes clinical trials to evaluate safety and effectiveness. Certain devices can reach the market through the less rigorous 510(k) process, named for the corresponding section of the Federal Food, Drug and Cosmetic Act, if manufacturers can show substantial equivalence to a legally marketed predicate device. Critics of this process have expressed concern that there are no safeguards to prevent recalled devices from being used as predicate devices. The Institute of Medicine recommended in 2011 that FDA replace 510(k) with a more robust system.