The “FDA Device Accountability Act,” introduced by Sens. Al Franken (D-Minn.) and Richard Burr (R-N.C.), would require the FDA to use the “least burdensome” requirement contained in the the FDA Modernization Act of 1997, according to a press release.
“The consistent and meaningful application of the ‘least burdensome’ principles is a critical part of improving and accelerating patient access to potentially life-saving medical devices. The [FDA Device Accountability Act] requires the Secretary of Health & Human Services to ensure that FDA reviewers receive training regarding the intent and application of the least burdensome requirements,” according to the release.
The bill would also mandate an audit by the FDA ombudsman to ensure that the least burdensome requirements are being met.
The Device Act also requires an audit by the FDA ombudsman as well as an assessment of the measurement used to track the implementation of the least burdensome requirements. It would also allow medical device approval applications to use institutional review boards for clinical trials.
“The use of a centralized IRB can streamline device trials occurring in multiple geographic locations, which may ultimately reduce the total time and resources required for manufacturers to study devices and get them approved by the FDA,” according to the release.
The bill would also require the FDA to update its guidance on waiving the requirements of the Clinical Laboratory Improvements Act for in vitro diagnostics.
“For the companies in Minnesota and across the country that are developing new and innovative medical technologies, the current government-approval process can be needlessly slow, frustrating, and costly,” Franken said in prepared remarks. “Many Minnesota device makers have expressed to me that inconsistencies and lack of clarity in the regulatory process not only delay patients’ access to new devices, but they also stifle innovation at their companies and threaten jobs in our state. We can do better, and these commonsense measures will help shorten the time it takes to bring a device to market, while ensuring safety for patients who can benefit from these life-saving technologies.”
“America is a global leader in medical research, development, and innovation,” Burr added. “Ensuring that safe medical devices are developed and reviewed quickly will help get them to patients faster, which will improve and save lives. This legislation will also help cut down on the total time it takes for patients to benefit from approved medical devices by permitting more efficient clinical trials. As Congress works to support innovation for healthier Americans, I hope my colleagues will see the benefit of these commonsense solutions and join me in supporting them.”