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Harkin, Enzi Welcome FDA Medical Device User Fee Agreement

WASHINGTON – Senators Tom Harkin (D-IA) and Mike Enzi (R-WY), the Chairman and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP), released the following statement welcoming today’s announcement that the Food and Drug Administration (FDA) has reached agreement with the medical device manufacturing industry on the user fees that help speed the FDA’s review of devices, bringing them to patients more quickly:

“This user fee agreement will ensure that life-saving medical devices reach patients who need them quickly and safely. We applaud the FDA and the industry for working together to quickly resolve outstanding issues to reach this agreement, which will encourage innovation and ensure that the review process for new medical devices is consistent and transparent.

“It is our hope that the Administration will send the final agreement to Congress soon so we can move forward with the work to authorize all four user fee agreements in a timely manner.”

Over the past several months, the HELP Committee has convened a series of bipartisan hearings to explore issues related to the user fee legislation.