To encourage healthcare technology innovation and update the 510(k) pathway, the regulatory agency said that it will soon release measures aimed to sunset predicate devices that are over a decade old. In the interest of promoting innovation, FDA Commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren, director of the FDAs Center for Devices and Radiological Health (CDRH), said in a statement yesterday that CDRH is deciding over the next few months whether to publish on its website a list of devices or manufacturers that cited predicate devices older than 10 years in their submissions. The pair also said that the agency is investigating whether or not to retire older devices as eligible predicates, a move that could require input from Congress.

Source: Click here