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Mark E. Brager
March 21, 2017

AdvaMed Statement on Senate Medical Device User Fee Hearing

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed), issued the following statement from President and CEO Scott Whitaker on today’s hearing in the Senate Health, Education, Labor, and Pensions Committee on reauthorization of the Medical Device User Fee Act:

“AdvaMed would like to thank the members of the Senate HELP Committee for holding today’s hearing on this important piece of legislation.

“We look forward to engaging with members of Congress moving forward with reauthorization legislation. We support this new MDUFA package because we believe it is good for patients, good for innovation and good for the agency.

“The agreement builds on the progress from the 2012 user fee agreement to further improve FDA’s device review process while maintaining robust standards for patient safety.

“Some of the key benefits in the new user fee agreement include:

  • Significant improvements for total review time goals, which will lower the total time goal for 510(k)s and PMAs to historical norms;
  • Greater accountability, including two independent analyses of FDA’s management of the review process – one at the beginning and one at the end of the MDUFA IV timeline;
  • Further process enhancements to increase the consistency and timeliness of the review process; and
  • Greater patient engagement provisions.

“Taken together, these elements are a recipe for continued successful interactions between FDA and the medical technology industry, which translates into more innovation and better treatments and cures for patients. AdvaMed will continue to work with Congress, FDA and other stakeholders to help make sure the agreement wins approval before the Sept. 30 deadline.”