CDRH Statements
Statements from the Center for Devices and Radiological Health, as we discuss significant steps towards continuing to promote and protect the public health.
December 2023
November 2023
October 2023
- CDRH Issues Guiding Principles for Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices
- CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam
- CDRH Recognizes 10-Year Anniversary of Cybersecurity Program and Continued Steps to Help Ensure Medical Device Cybersecurity
- CDRH Provides Update on the Total Product Life Cycle Advisory Program Pilot
September 2023
- CDRH Announces International Harmonization Strategic Plan
- CDRH Issues Updated Final Guidance on Breakthrough Devices Program
- FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program
July 2023
April 2023
March 2023
- CDRH Statement: CDRH Updates Safety Communication for Squamous Cell Carcinoma (SCC) in Scar Tissue around Breast Implants
- CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices
- FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices
- CDRH Statement on Emergency Use Authorization of Lucira Health’s COVID-19 & Flu Home Test