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.
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- CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices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