Senate Bill Would Change How FDA Reviews & Regulates Medical Devices

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:

• “Require FDA to address within two months any changes proposed to an appropriate standard established by a nationally or internationally-recognized standard organization;
• Require new training for FDA employees on those standards;
• Ensure a more transparent process for classifying devices, including providing “adequate time for initial presentations by the person whose device is specifically the subject of such review”;
• Explore the use of pilot projects to figure out how to better track devices in once they are marketed.”

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:

• Provide greater predictability and transparency to FDA’s process for recognizing international or national consensus standards;
• Update the law to give the agency the authority to no longer require premarket submissions for a small set of low-risk, Class I products (if FDA deems it appropriate);
• Promote transparency in the process for selecting panel members for FDA advisory committees; and
• Give FDA the authority to pilot alternative methods for improving adverse event reporting.

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.

Do you manufacture a medical device or any other type of FDA-regulated product? We can help ensure that your product is compliant with all regulatory and legislative requirements. Do not hesitate to contact us with questions about preparing for these or any other regulatory standards. For additional information on our services and how we can help you, contact us today.