Emerging from a global pandemic, medical device pioneers are innovating at never-before-seen levels. Our society stands at the edge of a Golden Age of medical technology.  

Key to this progress is an effective regulatory and policy environment.  

Thanks to the U.S. Food and Drug Administration and Congress, the U.S. medical device industry is well-equipped to continue delivering the innovations that save and enhance lives worldwide. The FDA review of medical devices for safety and effectiveness is the global gold standard. 

Congress is considering the latest agreement between the FDA and the industry to help fund agency consideration of medical devices with user fees.  

The fifth Medical Device User Fee Amendments reauthorization, MDUFA V, builds on and enhances the solid foundation previous agreements have built.  

MDUFA V comes at a pivotal time.  As the medtech industry responded to COVID-19, so did the FDA. Both are readjusting to regular business after tremendous performance demands. The agreement: 

Recognizes the unprecedented workload caused by the pandemic and the FDA’s tireless response to it, calling on the agency to improve performance beyond levels achieved in MDUFA IV, with additional resources and new full-time equivalent (FTE) employees for the agency to fulfill its mission to patients. 

Reflects the pandemic experience, and the need for agility and preparedness as demands increase or fluctuate, with several “firsts” that will lead to even greater performance, predictability, and consistency, including  

• enhanced hiring and performance goals that, if met, would result in first-ever additional funding; 
• clear pre-submission goals that will reduce the total time to issue FDA decisions for medical devices; and 
• new policies on carry-over balances and unused funds. 

Envisions the largest single financial contribution to the device user fee program, which will dramatically and positively impact the future of medtech innovation, by 

• securing a guaranteed funding amount of $1.784 billion; and  
• offering the agency the opportunity to collect up to an additional $115 million for supplemental program enhancements if clearly defined process targets are met.  

The agreement preserves everything that works well in the current system, builds in support of specific needs to fulfill the critical mission of device review, and reflects lessons learned about shifting workloads and priorities in device development and review during a global pandemic. 

There’s no way to do this alone.  Congress, industry, and the FDA must step into this bold new world of patient treatments and cures together.  

AdvaMed stands ready to do our part to ensure the successful enactment of the historic MDUFA V agreement. 

Legislative Status  

The U.S. House of Representatives Energy and Commerce Health Subcommittee held a hearing March 30, 2022. Janet Trunzo of AdvaMed testified.  

The U.S. Senate Health, Education, Labor, and Pensions Committee held a hearing April 5, 2022.    

What’s Next?

The committees will present legislation reflecting the agreement for committee consideration. 

Stay tuned for updates.