(Remarks as prepared for delivery, by video)

Thank you, Mark [Leahey], for that kind introduction.

It is my pleasure to join with you and the members of MDMA … even if just virtually … for your annual meeting this year.  

I was very much looking forward to being with you in person. 

Unfortunately, however, we’re all dealing with the health crisis that has so disrupted our lives, not just in terms of logistical issues relating to work and scheduling meetings, but in the very serious and personal challenges and losses that so many in our communities are facing.

It’s precisely because of these continuing challenges that I am heartened you’ve decided to hold your annual meeting, with the power of technology.

This organization has so much to offer in support of the efforts to combat the pandemic. 

And this gathering provides an important forum for your input and expertise, a place to generate ideas and shared conversation that can help overcome the daunting hurdles we face.

MDMA member companies know what it is to overcome obstacles, whether involving a particular product, or in the development of your businesses themselves. 

You’ve done this through a combination of determination, commitment, and ingenuity. 

We’re counting on that same energy and creativity to defeat this pandemic.

We need to work together and learn from each other in our search for answers.

As a member of the White House Task Force on COVID 19, I’ve seen just how important it is for us to marshal resources and ideas as we combat this crisis. 

You’ve been working hard to produce and distribute critical medical products and components at a time when they are desperately needed.

At the FDA, we’re working diligently to support those efforts, and to incorporate your creativity.

We’re doing whatever we can to increase the supply and to speed the production and delivery of key medical products, and we won’t stop looking for ways we can adapt our work to meet the needs of our nation during this pandemic.

If there’s one thing we’ve seen reaffirmed during this crisis, it’s how important medical devices, including diagnostics, are to health care generally, and to countering this pandemic in particular.

We’ve seen this in in the efforts to ensure that health care workers and others on the front line, as well as patients, have the proper protections they need, and in the essential work to expand diagnostic testing capabilities.

To this end, I want to especially acknowledge the work of the FDA’s Center for Devices and Radiological Health. 

As many of you know from personal experience, CDRH is extraordinarily engaged with manufacturers to help ensure the availability of the devices in high demand due to the pandemic, such as PPE, ventilators, diagnostic tests and supplies, and many others that may be prone to potential shortage if there is a supply disruption.

And we’ve been fast and forward-leaning in issuing Emergency Use Authorizations and “Umbrella EUAs” for certain devices as well as a number of guidances that allow for maximum regulatory flexibility to ensure that patient needs are met.

We have also published conservation strategies for PPE to help guide uses of these products if there are concerns with availability. 

As the nation seeks action and answers from the FDA, we will continue our work to provide both.

Your input, expertise, and leadership are critical to our ability to determine what is needed and to find, develop, and support fast and innovative solutions. 

So, thank you for your diligence, creativity, and commitment during this challenging time. 

And please don’t hesitate to contact us with any questions, suggestions, or ideas, whether related to the current crisis, or in the future. 

We’ll look forward to continuing to work closely with you, and to support you, as we fulfill our mission. That is to deliver on the promise of science, with data-driven results and rigorous scientific research and analyses to protect the health of the American public.

Thank you.