Medical Device Safety and Innovation Reports
The FDA’s Center for Devices and Radiological Health (CDRH) seeks to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress.
Below are links to our reports, evaluations, documents, and webpages about our programmatic efforts.
- CDRH 2024 Innovation Report (April 2024)
- CDRH 2024 Safety Report (April 2024)
- Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (April 2018)
- CDRH Regulatory Science Priorities
- FDA Has Taken Steps to Strengthen the 510(k) Program (November 2018)
- FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework (2014)
- Medical Device Reporting (MDR) Rate in 510(k) Cleared Devices Using Multiple Predicates (2011)
- Understanding Barriers to Medical Device Quality (2011)
- CDRH Plan of Action for 510(k) and Science (2011)
- CDRH Preliminary Internal Evaluations (2010)