FOR IMMEDIATE RELEASE
Sept 19, 2023
The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and
Melissa Torres, Associate Director for International Affairs, CDRH
Today, CDRH is issuing a draft International Harmonization Strategic Plan to encourage harmonization, convergence, and reliance among medical device regulatory authorities. As the design, manufacture, distribution and use of medical devices have become increasingly complex and global, the need for harmonized approaches and reliance among regulatory authorities has become more vital. In this draft strategic plan (“the Plan”), CDRH outlines our specific goals, strategies, and activities towards international harmonization, convergence, and reliance. This Plan builds on our existing international work and serves as a foundation for our work to come.
The Medical Device User Fee Amendments (MDUFA) for FY2023-2027 (MDUFA V) include several commitments specific to international harmonization and provide additional CDRH resources for this important work. This Plan describes the strategies and activities CDRH will use to meet these MDUFA V commitments.
CDRH recognizes that successful international harmonization will require the integration of ideas and perspectives from key stakeholders, including other regulatory authorities, industry, conformity assessment bodies, patients, standards development organizations, and CDRH staff. We look forward to working with and learning from others as we all act to further international harmonization, convergence, and reliance.
CDRH will provide updates, over the next four years, on our work toward the strategies and activities outlined in this plan.
CDRH’s mission is to assure U.S. patients have timely, continued access to safe, effective, and high-quality medical devices. The technologies of medical devices are evolving at a rapid pace, with increasingly complex and global design, manufacture, distribution, and use. Each regulatory authority may develop and implement its own path to market products and regulatory requirements, especially as emerging technologies are considered. But resources may not be maximized when regulatory authorities must administer, and industry must navigate adherence to, numerous and sometimes redundant regulatory requirements.
CDRH has long recognized the importance of and worked towards globally harmonized medical device regulation, policy and practices. Harmonization, convergence, and reliance may reduce regulatory inefficiencies and promote a more effective regulatory model for medical devices. With this Plan, CDRH outlines our specific strategies and activities towards international harmonization, convergence, and reliance. By working to reduce redundant expectations and requirements across medical device regulatory systems, the FDA is fostering better access by patients – in the U.S. and globally – to safe, effective, and high-quality medical devices.
This Plan continues the FDA’s current work with international stakeholders to further harmonization efforts and includes specific strategies to directly encourage harmonization, convergence, and reliance among regulatory authorities. CDRH intends to increase engagement in global harmonization projects and initiatives, create a new mechanism to work with trusted partners, and conduct specific outreach to other regulatory authorities.
CDRH also looks forward to strengthening existing relationships with other regulatory authorities. These relationships are critical to risk-based decision-making using the most up-to-date scientific and regulatory intelligence, as well as furthering broader work on harmonization, convergence, and reliance. CDRH will not only look outward, but also inward -- we will examine our own implementation of international best practices and share our findings, conclusions, and next steps with others. And lastly, we look forward to supporting new ways to listen and learn from stakeholders on this global journey.
CDRH looks forward to working on the strategies and activities outlined in this Plan over the next four years. We are committed to this Plan and to sharing our progress towards it. We intend to publish annual assessments of the international harmonization activities described in this Plan. We look forward to public comment and feedback as we refine our efforts.
As always, our drive is to achieve the highest quality safe and effective medical devices for every U.S. patient.