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MDMA Board Member Testifies Before House Committee Examining Medical Device User Fees

Tuesday, March 28, 2017  
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MDMA Board Member Testifies Before House Committee Examining Medical Device User Fees

 

WASHINGTON, DC -- MDMA Board Member and Founder of CVRx, Inc. Robert Kieval testified before the House Energy and Commerce Committee’s Subcommittee on Health today for their hearing entitled “Examining FDA’s Medical Device User Fee Program.”

 

Kieval highlighted the importance of building on past improvements within the user fee program, while ensuring that FDA continues to provide more predictable and transparent regulatory pathways.

 

“With the additional resources provided in MDUFA IV, and if implemented correctly, we believe that this proposed agreement can help further improve access for American citizens to safe and effective new medical technologies,” said Kieval.  “We thank FDA for these productive negotiations, and we look forward to continuing to work with them and Congress to maintain a regulatory environment that rewards innovation while ensuring patient safety.”

 

The hearing follows a similar one held by the Senate HELP Committee last week that also examined the numerous user fee agreements being reviewed by Congress.

 

MDMA remains committed to working with Congress and all stakeholders to ensure that the user fee program is reauthorized to allow the FDA to improve its ability to provide safe and effective medical technologies for patients and providers.


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