In January, the FDA announced a plan to improve the 510(k) program. The plan includes 25 actions the FDA’s Center for Devices and Radiological Health (CDRH) intends to take this year, including new guidance and improved staff training. Among the actions are the issuance of new guidance on 510(k) modifications by June 15. The plan also includes an evaluation of automatic class III designation (de novo) guidance to streamline the classification process for these innovative, lower-risk medical devices, which will be completed by September 30. Also, the CDRH plans to establish a Center Science Council of senior agency experts for improved science-based decision making. Another action will be the implementation of a pilot program by March 31 to study the use of an “assurance case” framework. For seven additional recommendations, the CDRH is awaiting feedback from the Institute of Medicine.

Source: FDA