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
July 2023
April 2023
March 2023
- CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices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: CDRH Updates Safety Communication for Squamous Cell Carcinoma (SCC) in Scar Tissue around Breast Implants
- CDRH Statement on Emergency Use Authorization of Lucira Health’s COVID-19 & Flu Home Test