Oversight hearing, Demands Greater Predictability for Medical Industry Job Creators

Press Release

U.S. Congressman Paul Gosar, DDS (AZ-01), participated yesterday in a hearing of the Oversight and Government Reform's Subcommittee on Health Care, District of Columbia, Census and National Archives. The Subcommittee was investigating Food and Drug Administration (FDA) medical device approval process and investigating ways to improve it. This hearing was necessary, as medical device companies are finding it increasingly difficult to bring new technology to market because of new regulations and bureaucratic red tape.

According to Gosar, "The medical device industry is struggling under an unpredictable and onerous approval process at the Food and Drug Administration. As a result, revenue and jobs are being lost in America, and we are falling behind in medical innovation. As a dentist, I know all too well the consequences for providers, patients, and our economy if we do not ask for serious, patient based reform at the FDA." Congressman Gosar is concerned that patients are doing without medical devices that can improve lives and save lives.

The medical device industry accounts for 7,100 direct jobs in the state of Arizona alone. It is a multi-billion dollar industry that provides substantial tax revenues to the state. According to a new research study published by Northwestern University, nearly two thirds of small medical device companies are obtaining approvals for their new innovations overseas. When surveyed, these companies pointed out the unpredictability of the 510(k) approval process at the Food and Drug Administration as a major reason why they are choosing not to launch their products in the United States first. Only 8 percent of those surveyed felt that the U.S. approval process was the most predictable in the world.

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