The statement from Stephen J. Ubl came in advance of the House and Senate beginning mark up of the legislation.
“AdvaMed commends the House and Senate for the steady progress being made in both chambers to reauthorize this vital legislation,” said Mr. Ubl, in the release. “Mark up is an important milestone in the reauthorization process, and we are encouraged by the bipartisan support this legislation has received. We are hopeful it will remain on track to pass in a timely fashion. … The medical device user fee agreement is crucial to maintaining our industry’s competitive leadership and our ability to continue to serve the patients and physicians who depend on us. … The user fee agreement strengthens FDA’s stringent product review process through a combination of groundbreaking accountability and transparency measures, process improvements and increased resources for the agency. Taken together, the agreement has the potential to increase the predictability, consistency and efficiency of FDA’s decision-making.”
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