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  1. Medical Devices News and Events

CDRH Welcomes 25th Session of the International Medical Device Regulators Forum

MARCH 11, 2024

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH)

I am honored to serve as the Chair of the International Medical Device Regulators Forum (IMDRF) in 2024 and to welcome all of our participants to the 25th session, hosted this week in Washington, D.C. 

This forum was created in 2011 out of the Global Harmonization Task Force, with the goal of harmonizing the world’s approach to how we oversee medical devices. At that time, seven nations and one public health organization stood up IMDRF.  

Today, we have close to 1,200 people joining us – our biggest attendance at an IMDRF meeting in history. Our attendees represent more than 60 countries and 550 public and private sector organizations.  

Our mission has not changed in 13 years – we share the vision that we can positively impact the health and quality of life of many people when we align on policies, standards, and practices. While we are proud of our attendance numbers this week, we must remember that IMDRF has not grown merely for the sake of growth. The global medical device industry and the technologies they develop are evolving at an unprecedented pace. It is our shared responsibility to assure these devices are fit for purpose before coming to market, they remain so once on the market, and that patients have timely access to them.  Therefore, the work of IMDRF is vital to our shared success.  

IMDRF has grown to meet the innovations and the challenges of our medical device ecosystem in several important ways.  For example, our community encourages collaboration and harmonization worldwide. And one of the most effective ways to harmonize is through reliance. By building trust through the sharing and protection of information and expertise, regulators may rely on the pre- and post-market decisions of other jurisdictions, which can save significant time and resources. Reliance can also increase market and patient access to the best devices. We view models of reliance as a win for all of public health. As Chair and Secretariat of IMDRF in 2024, we are prioritizing the topic of reliance.

One of the core principles of IMDRF is that our work should be available to all. Our working groups develop technical guidances and other documents to provide policies and best practices to the entire medical device community. For example, in the past year, we issued technical guidances for harmonizing regulatory pathways for personalized medical devices, and for Software Bills of Materials in cybersecurity settings. And you will hear many more “hot” topics this week, such as artificial intelligence/machine learning-enabled devices (AI-ML) and digital labeling. We encourage everyone to review, understand and hopefully adopt IMDRF documents. That said, we do appreciate that these documents might be complex.  Therefore, we have dedicated time on our agenda this week to explore how we can best provide training on our documents to facilitate adoption and appropriate use.  

IMDRF has also grown with the medical device community in a more immediate way – through partnerships. We believe that close collaboration between the public and private sector is necessary to ensure that devices are fit for purpose.

This week, we will hear from regulators, industry, academia, and other stakeholders on ways we can more effectively support and engage one another. Through all of these discussions, we challenge our participants to think about how we can and should expand our global membership and work closely to advance the work of IMDRF.  

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