FDA’s CDRH Division Releases Draft Strategic Plan on International Regulatory Harmonization to Lower Redundancy and Reduce Burden on Device Manufacturers

The Center for Devices and Radiological Health (CDRH) recently released its draft strategic plan for international regulatory harmonization. The plan emphasizes the importance of globally harmonized medical device regulatory policies and practices. The goal of this initiative is to reduce redundancy in expectations across various medical device regulatory systems, ultimately benefiting patients in the United States and worldwide by ensuring access to safe, effective, and high-quality medical devices. As medical device design, manufacturing, distribution, and utilization become more complex and global, the need for harmonized approaches, consistent expectations, and collaboration among regulatory authorities becomes increasingly evident and urgent. Over the next four years, CDRH plans to strengthen diplomatic relationships, engage in global harmonization projects, establish mechanisms to collaborate with trusted partners, and conduct outreach with regulatory authorities to encourage harmonization, convergence, and reliance. CDRH is committed to sharing its progress through annual assessments and seeks public input to enhance efforts in the evolving global regulatory landscape.

The medical device industry has become highly globalized and intricate, involving various economies in product design, development, manufacturing, and distribution. Rapid technological advancements further complicate matters. Each economy often needs to establish its regulatory framework and market entry processes, especially for emerging technologies. In the plan, CDRH recognizes that these separate regulatory frameworks can lead to inefficiencies and redundancies in regulatory requirements, wasting resources for both regulatory authorities and the industry. Under the plan, CDRH outlines several strategies to better integrate the international device regulatory system among different countries.

The first strategy is to increase engagements in international harmonization, convergence, and reliance efforts among countries. Currently, CDRH’s involvement in these efforts has been constrained by available resources. However, with the expected increase in funding and resources during MDUFA V (Medical Device User Fee Amendments – The Medical Device User Fee and Modernization Act (MDUFA) is a series of agreements between the FDA and the medical device industry. It aims to provide financial support to the Office of Device Evaluations (ODE) for the review of medical device submissions. MDUFA was initially authorized in 2002 for the fiscal year 2003, and subsequent reauthorizations have occurred every five years. FY 2023 marks the 21st year of MDUFA implementation.), and through this CDRH plans to significantly expand its engagement in international harmonization and convergence initiatives. The expansion will be both qualitative and quantitative, potentially involving more meetings, additional documents, and more complex projects. CDRH will evaluate its engagement annually, identifying opportunities for expansion in these efforts.

The second strategy is to create mechanism for CDRH to share best practices with trusted partners. The Center for Devices and Radiological Health (CDRH) plans to engage with trusted regulatory partners who have confidentiality commitments with the United States to facilitate discussions on standardized policies and processes. By the end of fiscal year 2023, FDA will identify and initiate engagement with regulatory authorities where information sharing supports harmonization efforts. By the end of fiscal year 2024, CDRH will establish a mechanism to exchange best practices in device evaluation and identify opportunities for international regulatory strategy convergence and reliance. These activities will continue throughout the remainder of MDUFA V.

The third strategy is to assess the extent of CDRH implementation of IMDRF (International Medical Device Regulators Forum) technical documents. The IMDRF documents encompass standard policies and practices that have received approval from all regulatory authorities within the IMDRF Management Committee. CDRH (Center for Devices and Radiological Health) intends to assess its own policies in comparison to IMDRF policies. This assessment will also involve evaluating CDRH’s implementation of each IMDRF technical document to identify opportunities for further harmonization. CDRH plans to publish assessments of these technical documents over several years, with the goal of assessing all of them by the end of FY 2027. These assessments will be made publicly available on CDRH’s International Affairs website.

The fourth strategy is to support creation of a forum to engage with stakeholders to identify opportunities for regulators to leverage one another’s approach to decision making. Under this initiative, CDRH plans to establish a forum to engage with stakeholders and explore opportunities for regulatory authorities to leverage each other’s decision-making approaches. Starting in FY2024, CDRH will assess and report its efforts to support the creation of this forum. Activities may involve identifying potential programs or methods of engagement, outlining priorities for CDRH involvement, and understanding the level of interest and considerations of other stakeholders in alignment with CDRH’s goals.

The final strategy is to participate in outreach activities to encourage harmonization, convergence, and reliance. Starting in FY2024, CDRH plans to participate in outreach activities at least six times each fiscal year, involving discussions on international best practices with an international audience. Coordination with other parts of the U.S. government may also be considered where appropriate to support these efforts.

Overall, the steps by CDRH offer further funding and set initiatives to increase collaboration between the U.S. and international regulatory organizations for medical devices. These steps could ultimately lead to a lower regulatory burden for global device manufacturers and greater standardization in regulatory approval processes.