MEDICAL TECHNOLOGY INNOVATORS GET BOOST FROM SENATE COMMITTEE

Bill eases FDA user fee burden for smaller firms

Washington, D.C. July 20... The Medical Device Manufacturers Association (MDMA) today welcomed action by a Senate Committee to help smaller medical technology innovator companies afford the rising costs of device submission fees for important new products.

The Senate Health, Education, Labor and Pensions Committee unanimously passed out of committee the “Medical Device User Fee Stabilization Act of 2005.” This bill, among other provisions, increases the threshold for granting small business relief from $30 million to $100 million for device submissions.

The bill also places a limit on the annual increases in “user fees” medical device firms must pay to the U.S. Food and Drug Administration in exchange for timely review and approval of products. In addition, the bill enhances the labeling and tracking of reprocessed single use devices.

MDMA has long argued for fairness in how the user fee law, known as MDUFMA, treats smaller device firms, because much technological innovation originates with entrepreneurial R&D driven firms. “MDMA is gratified by the bipartisan leadership displayed by the HELP Committee today, especially that of Chairman Mike Enzi (R-WY) and Ranking Member Edward Kennedy (D-MA),” said MDMA Executive Director Mark Leahey. “The bill embraces many of the important policies and procedures that MDMA sought when the user fee law was first enacted.”

MDMA Chair Nancy Briefs added: “MDMA is particularly proud of today’s developments, because for a long time this association has understood the importance of a healthy environment in which smaller companies can innovate, grow, and improve patient care. Today, Members of Congress demonstrated they understand and agree with that.

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The Medical Device Manufacturers Association (MDMA) seeks to improve the quality of patient care by encouraging the development of new medical technology and fostering the availability of innovative products in the marketplace. A national trade association based in Washington, D.C., MDMA represents thousands of innovators and entrepreneurs in the medical device community, including over 200 dues-paying members who develop and manufacture medical devices, diagnostic products, and health care information systems.