Harmonisation Efforts of the CDRH

Recommendation

Monday, 29 April 2024 10.00 - 16.00 h

Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation
Includes USP Speaker Update on the Analytical Procedure Lifecycle

The Center for Devices and Radiological Health is responsible for medical devices in the USA. The CDRH is also increasingly involved in harmonisation efforts. What is planned?

There is an independent website under the title CDRH International Affairs. It is comprised of a compact 3-page description of how the exchange with other regulatory authorities takes place and how training measures on FDA regulations can be organised for other authorities. Finally, a list describes the FDA's "resources" for other authorities. This includes the structure of the FDA, the CDRH Learn system and various databases.

To this end, an "International Harmonisation Draft Strategic Plan" was published in September.

The aim of the plan is to achieve greater international harmonisation. The 2024 meeting of the International Medical Device Regulators Forum (IMDRF) will serve as one element of this. Next year's meeting will be organised by the FDA. Of course, it is also always about protecting the US population. But it is about the timely supply of this population with innovative, high-quality, safe and effective medical devices as well.

The terminology of the harmonisation efforts is supposed to be based on the WHO document "Good regulatory practices for regulatory oversight of medical products".  

The plan sets out 5 strategic objectives in order to accelerate harmonisation efforts

• Strategic Goal 1: Increase engagements in international harmonization, convergence,
  and reliance efforts 
• Strategic Goal 2: Create mechanism for CDRH to share best practices with trusted partners (i.e., agencies with which the U.S. has extensive diplomatic relationships and confidentiality agreements).
• Strategic Goal 3: Assess the extent of CDRH implementation of IMDRF technical documents
• Strategic Goal 4: Support creation of a forum to engage with stakeholders to identify opportunities for regulators to leverage one another's approach to decision-making
• Strategic Goal 5: Participate in outreach activities to encourage harmonization, convergence, and reliance (e.g. technical discussions)

Four appendices conclude the draft plan. Appendix A describes the activities of the CDRH with regard to international harmonisation. Appendix B provides links to the Medical Device User Fee Amendments (MDUFA). Appendix C describes initial considerations regarding the integration of annual reports. Appendix D provides an overview of the CDRH's harmonisation activities in the 2022 fiscal year.

The strategic plan is scheduled to run for four years and regular updates will be published.