CDRH International Affairs

June 3, 2025 – The International Harmonization Annual Assessment for Fiscal Year 2024 is now available.

On This Page:

• Overview
• International Harmonization Annual Assessment for Fiscal Year 2024
• Strategic Plan
• Information Exchange with Other Regulators
• Resources for Foreign Medical Device Regulatory Authorities

Overview

Safety standards and regulations for medical devices vary from country to country. The FDA’s Center for Devices and Radiological Health (CDRH) is committed to assuring patients and providers have timely and continued access to safe, effective, and high-quality medical devices by engaging with international regulatory agencies to promote alignment in medical device regulations and standards.

CDRH recognizes international harmonization is an important step in reducing barriers to medical devices with the potential for important public health impact.

International Harmonization Annual Assessment for Fiscal Year 2024

CDRH worked diligently throughout Fiscal Year 2024 (FY2024) with international medical device representatives to meet MDUFA V commitments with the goal of assuring safe, effective, and high-quality medical devices.

To meet that goal, CDRH is:

• Fostering relationships globally with device parties, 
• Encouraging harmonized regulatory approaches among regulatory authorities, which will maximize available resources and ultimately help assure safe, effective, and high-quality medical devices, and  
• Promoting opportunities to share information and build trust, ensuring that CDRH and our global partners can make the most informed regulatory decisions within the context of an interconnected ecosystem. 

The annual assessment addresses progress in FY2024 along five strategies:

• Strategy 1: Increase engagements in international harmonization, convergence, and reliance efforts.  
• Strategy 2: Create a mechanism for CDRH to share best practices with trusted partners.  
• Strategy 3: Assess the extent of CDRH implementation of IMDRF technical documents.  
• Strategy 4: Support creation of a forum to engage with interested parties to identify opportunities for regulators to leverage one another’s approach to decision-making.  
• Strategy 5: Participate in outreach activities to encourage harmonization, convergence, and reliance. 

Our progress is detailed in the CDRH International Harmonization Annual Assessment for Fiscal Year 2024.

Strategic Plan

September 18, 2023 update: The FDA issued the draft Center for Devices and Radiological Health International Harmonization Strategic Plan. This plan includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities, as applicable, and builds on CDRH’s current work with international stakeholders.

As part of MDUFA V obligations and over the next four years, CDRH will provide updates on our work towards the strategies and activities outlined in this plan.

Read the Strategic Plan

Please submit all public comments to the docket FDA-2023-N-4897, available at Regulations.gov.

Information Exchange with Other Regulators

CDRH meets with manufacturers and other regulatory authorities to exchange device and regulatory information through web-based training, scientific and policy discussions, and confidentiality commitments.

Fostering global regulatory convergence

Following our term as 2024 chair of the International Medical Device Regulators Forum (IMDRF), the FDA will continue to work collaboratively to reach consensus on common goals, foster global regulatory convergence, and leverage resources to make safe and effective medical devices available globally.

Training through Regulatory Capacity Building

CDRH may engage in virtual or face-to-face regulatory capacity building efforts to provide other regulatory authorities with insight or training on the FDA’s regulatory framework or technical documents created under harmonization efforts such as the International Medical Device Regulators Forum or the Medical Device Single Audit Program (MDSAP).

Government to Government Exchange

Through CDRH’s International Affairs, regulatory information of mutual interest is exchanged with international regulatory counterparts. CDRH can exchange information that is publicly available, and information that is non-public when conducted under the U.S. FDA’s Confidentiality Commitments. This exchange allows regulators to leverage resources, aggregate data, and share information for better informed regulatory policies and decisions. These confidential information exchanges with other regulators can be performed on a routine or ad-hoc basis.

Sharing information and working in partnership to address issues of mutual interest and concern ultimately allows patients timely access to safe, effective, and high-quality medical devices.

Resources for Foreign Medical Device Regulatory Authorities

Below is a list of resources covering the FDA organizational structure, online training modules, and databases that provide an overview of CDRH regulatory activities.

FDA Office of Global Policy and Strategy 

Center for Devices and Radiological Health (CDRH) Overview

• CDRH Structure
• Introduction to FDA’s Regulation of Medical Devices

CDRH Learn

A full list of English and Spanish training modules are available online at CDRH Learn

Medical Device Databases

• Premarket Approvals
• 510(k)
• AccessGUDID - Identify Your Medical Device (nih.gov)
• MAUDE (Manufacturer and User Facility Device Experience)
• Recalls
• Registration and Listing
• FDA Inspections

Additional Resources

• Confidentiality Commitments
• The FDA Withdraws as a Member of the Global Harmonization Working Party

For more information contact: CDRHInternational@fda.hhs.gov.