Over the years, the FDA’s Center for Devices and Radiological Health (CDRH) has worked to evaluate, improve, and modernize the 510(k) Program to drive innovation, and bring safe, effective, and high-quality medical devices to the marketplace. The links below provide access to several evaluations, reports, and other documents and webpages related to the 510(k) Program published by CDRH. Some of this information may be archived web material (see FDA.gov Archive) that may be out of date, but is being presented for historical purposes only.

• FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program - Program Updates (July 2023) 
• FDA Has Taken Steps to Strengthen the 510(k) Program (November 2018) (archived)
• Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (April 2018)
• CDRH Plan of Action for 510(k) and Science (archived)
• CDRH Preliminary Internal Evaluations (archived)