On March 17, 2016, the Improving Medical Device Innovation Act was introduced in the Senate’s Health, Education, Labor, & Pensions (HELP) committee. The bill, championed by Senators Amy Klobuchar (D – MN) and Pat Roberts (R – KS), would grant FDA the authority to get rid of the required premarket submission for certain low risk class I and II medical devices.
In addition to exempting devices from premarket submission requirements, according to RAPS the bill would also:
Advanced Medical Technology Association (AvaMed), an industry group “that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around the world,” has announced its unwavering support for the bill. According to their press release, JC Scott, Senior Executive Vice President, Government Affairs stated that:
“FDA has made great strides in recent years to improve the efficiency, predictability and transparency of its medical technology review process. But we believe that more can be done so that FDA is operating at maximum effectiveness to ensure patients have timely access to medical innovations.”
Furthermore, he also stated that, if enacted, this bipartisan bill will “make needed changes to streamline a number of the agency’s current procedures.” As such, Mr. Scott said that, if it is passed the bill will:
It will be very interesting to watch as this bill makes its way through the legislative system. Only time will tell what the outcome will be for the Agency.
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