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.
January 2025
December 2024
November 2024
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- CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices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
January 2023