CDRH Statements

Subscribe to CDRH Email Lists

Follow Us on Social Media

 

---

January 2025

• Medical Device Supply Chain Vulnerabilities and the Public Health Impact They Have on Our Most Vulnerable Patients

December 2024

• CDRH Unveils Home as a Health Care Hub’s Idea Lab to Help Reimagine How New and Existing Medical Technologies Can Be Incorporated Into the Home

November 2024

• CDRH Announces Communications Pilot to Enhance Medical Device Recall Program

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 Issues Guiding Principles for Transparency of Machine Learning-Enabled Medical Devices

April 2024

• FDA Launches Health Care at Home Initiative
• 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

• CDRH Statement: CDRH’s Continued Commitment to Breast Implant Safety

January 2024

• CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs
• CDRH Statement on Philips’ Announcement
• FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made

2023 CDRH Statements

December 2023

• FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder

November 2023

• CDRH Takes Steps to Advance Further Discussions on Pulse Oximeters

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

• CDRH Announces New Standards Recognition to Support Innovation in Medical Device Sterilization

April 2023

• CDRH Announces Radiation Sterilization Master File Pilot Program

March 2023

• CDRH Statement: CDRH Updates Safety Communication for Squamous Cell Carcinoma (SCC) in Scar Tissue around Breast Implants
• 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

• FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes

2022 CDRH Statements

• CDRH Hosts Workshop in Partnership with NIH, Continues Commitment to Advance Medical Device Innovation to Help Mitigate Opioid Crisis
• CDRH Launches the Total Product Life Cycle Advisory Program Pilot

Contact Information

• Trade Press Inquiries