Senators introduce act to ease medical device regulations

U.S. Senators Amy Klobuchar (D-M.N.), Richard Burr (R-N.C.) and Michael Bennet (D-Colo.) have introduced the Medical Device Regulatory Improvement Act, which aims to decrease regulatory burdens on new medical devices to spur innovation.

Introduced Oct. 13, the legislation would clarify the FDA’s current least burdensome requirements to reduce review times. Recent studies report that the average time to approve a 510(k) application has increased 43 percent over recent years and time to approve a premarket approval application has increased 75 percent.

The legislation would also “restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government,” the senators wrote in a joint statement. This is necessary, they explained, because current conflicts of interest restrictions are overly stringent, making it difficult for the FDA to find qualified experts to serve on advisory committees.

Additionally, the bill would direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the FDA’s Center for Devices and Radiologic Health.