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Washington, D.C. – Yesterday, U.S. Representative Richard Hudson (NC-08), a leader on the Energy and Commerce Subcommittee on Health, introduced the Quality Systems Certification Act of 2017 (H.R. 2483) to improve the efficiency of FDA’s medical technology review process and help ensure more timely patient access to the latest medical innovations.

“I continually hear from constituents about the rising cost of medical care and I am always looking for common sense solutions to solve this problem,” said Rep. Hudson. “By streamlining the approval process and cutting back regulatory burdens, this common sense legislation will make the FDA more efficient and enable manufacturers to spend more time developing new innovations in patient care. I look forward to working with my colleagues to advance patient-first solutions like this that will ultimately lower costs and improve access to vital medical technology.”

Rep. Larry Bucshon, M.D. (IN-08) is an original cosponsor of the legislation. H.R. 2483 would create a voluntary program under which medical technology companies could have their quality system certified by an FDA-authorized third party. The certification would be valid for two years and would allow companies to self-certify certain low-risk changes to devices that do not involve major technology changes or changes in the product’s intended use.

Taking these items off of FDA’s plate, while still ensuring that companies are accountable, would be a significant reduction in FDA’s workload and allow the agency to focus on higher-priority activities. This program would also produce notable cost and time savings for companies, allowing them to focus on the next generation of innovative solutions for patients.


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