CDRH International Affairs
Update: November 27, 2023
The FDA announced its withdrawal as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). In 2024, the FDA, as chair of IMDRF, 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.
On This Page:
- Overview
- 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.
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.
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.
Training through Regulatory Capacity Building
CDRH may engage in virtual or face-to-face 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 Learn
A full list of English and Spanish training modules are available online at CDRH Learn
Medical Device Databases
- Premarket Approvals
- 510(k)
- MAUDE (Manufacturer and User Facility Device Experience)
- Recalls
- Registration and Listing
- FDA Inspections
Additional Resources
For more information contact: CDRHInternational@fda.hhs.gov.