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.
July 2024
- CDRH Announces Reorganization of Several Offices to Increase Organizational Agility and Advance Public Health Mission
- CDRH Announces Expansion of the Total Product Life Cycle Advisory Program
June 2024
- CDRH Announces Partnership to Develop New Methods to Accelerate Diagnostic Device Development for Underserved Populations
- CDRH Issues Guiding Principles for Transparency of Machine Learning-Enabled Medical Devices
April 2024
- FDA Launches Health Care at Home Initiative to Help Advance Health Equity
- CDRH Issues 2024 Safety and Innovation Reports
- CDRH Unveils New Dataset to Help Improve Chemical Characterization Methods for Biocompatibility of Medical Devices
March 2024
- FDA Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
- FDA Provides Update on Plastic Syringes Made in China, Issues Warning Letters Related to Violative Products
- CDRH Welcomes 25th Session of the International Medical Device Regulators Forum
February 2024
January 2024
- CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs
- CDRH Statement on Philips’ Announcement
- FDA Elevates Office of Strategic Partnerships and Technology Innovation to Super Office in CDRH
- FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
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- CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices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