The Consumers Union and patient safety advocates have taken their campaign for improved medical device safety to Washington, D.C., according to a news release.
In particular, the group is pushing for improvements in the Medical Device User Fee Act. The FDA recently completed negotiations with the device industry over the shape of MDUFA reauthorization legislation that must be passed later this year. However, the Consumers Union has expressed concern that the agreement does not include "important safety provisions," such as making sure faulty devices aren't used to clear similar implants and giving the FDA authority to require clinical trials after devices go onto market.
"The agreement is disappointing because it fails to include critical safety reforms needed to better protect patients and falls short of the resources the FDA needs to keep up with the volume and complexity of device applications," said Lisa Swirsky, senior policy analyst for Consumers Union, in the news release. "This year's legislation will govern the safety and quality of medical devices over the next five years. Congress should strengthen the FDA's ability to protect consumers."
In particular, the group is pushing for improvements in the Medical Device User Fee Act. The FDA recently completed negotiations with the device industry over the shape of MDUFA reauthorization legislation that must be passed later this year. However, the Consumers Union has expressed concern that the agreement does not include "important safety provisions," such as making sure faulty devices aren't used to clear similar implants and giving the FDA authority to require clinical trials after devices go onto market.
"The agreement is disappointing because it fails to include critical safety reforms needed to better protect patients and falls short of the resources the FDA needs to keep up with the volume and complexity of device applications," said Lisa Swirsky, senior policy analyst for Consumers Union, in the news release. "This year's legislation will govern the safety and quality of medical devices over the next five years. Congress should strengthen the FDA's ability to protect consumers."
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