Lawmakers Unveil FDA Reform Legislation Aimed to Reduce Burden on Medical Device Manufacturers

The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that some members of the U.S. House of Representatives and U.S. Senate have unveiled bills that they say will reduce regulatory burdens on medical device manufacturers and boost innovation.

Three U.S. senators introduced the Medical Device Regulatory Improvement Act on Oct. 13. The next day, 10 members of the House Energy & Commerce Committee unveiled a package of 10 bills targeting the U.S. Food and Drug Administration (FDA)'s regulatory process.

The bills come after months of criticism from some lawmakers who say the agencys regulatory program for devices is inconsistent, slow, and unpredictable.

"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," said Sen. Richard Burr, R-NC in a press release announcing the Senate legislation. Burr is one of the bill sponsors along with Sens. Amy Klobuchar, D-MN, and Michael Bennett, D-CO.

The Medical Device Regulatory Improvement Act includes provisions which "will ensure that when making regulatory decisions on medical devices, the FDA focuses only on the relevant information during the decision-making process, considers appropriate alternatives to reduce the time, effort, and cost of reaching regulatory decisions, and uses all reasonable mechanisms to reduce review times when making these decisions."

In addition, the bill aims to ease the agencys conflict-of-interest restrictions, which the senators say can inhibit the FDA from finding qualified experts to serve on advisory committees.

Some of the bills in the House package focus on those same issues.

FDA Spokeswoman Karen Riley said the agency had no comment on any of the legislation.