Hudson introduces medical device bill

U.S. Rep. Richard Hudson, R-Cabarrus, introduced a bill this week that aims to improve efficiency of a medical technology review process and ensure more timely access to medical advances.

The bill is numbered H.R. 2483 and titled Quality Systems Certification Act of 2017. It would create a voluntary program for companies to have their quality assurance system certified. The certification would last for two years. Companies could self-certify certain low-risk changes, a news release said.

“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 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.”

Hudson’s news release says the bill would significantly reduce the Food and Drug Administration’s workload and allow the agency to focus on higher-priority items.