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Bill would cut regulatory red tape for medical devices

Bill would cut regulatory red tape for medical devices

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Legislation that would streamline the regulatory process for some medical devices has been filed in the Senate.

The Medical Device Regulatory Improvement Act, S. 1700, introduced by Sens. Amy Klobuchar, D-Minn., Richard Burr, R-N.C., and Michael Bennet, D-Colo., would streamline the Food and Drug Administration’s regulation process for certain medical devices by clarifying some of the current least burdensome requirements.

Under the bill, FDA officials will be able to focus only on the relevant information during the decision-making process, consider appropriate alternatives to reduce the time, effort and cost of reaching regulatory decisions and use all reasonable mechanisms to reduce review times when making these decisions. The major safety requirements and review process for medical devices will remain unchanged.

“In order to provide American patients access to the most cutting-edge medical therapies and advances, we need to fix what is broken at the FDA by restoring regulatory certainty and predictability,” Burr said. “By streamlining and ensuring the least burdensome approach to FDA’s regulation of medical devices, we not only take a key step toward restoring America’s leadership in the research and development of life-saving products, but uphold our promise to patients.”

In August, Bennet sent a letter to FDA Commissioner Margaret Hamburg pushing for reformed FDA regulations that he said would foster innovation and competitiveness and position the FDA to serve as a driver of the global economy.

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