Lawmakers Plan Bill In Response To GAO Power Morcellator Report
Several US House lawmakers are drafting a bill in response to a Government Accountability Office report finding that FDA's Medical Device Reporting system has shortcomings that may have missed adverse events for laparoscopic power morcellators. The devices have been linked to an increased risk of spreading cancer in women undergoing fibroid surgery.
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New details about the planned pilot launch of the National Evaluation System for health Technology were included in US FDA's recently posted user-fee reauthorization commitment letter. At least one PMA and one 510(k) product type must be piloted on the real-world evidence system. Device center director Jeff Shuren continued to tout the program at this year's AdvaMed conference.
The US agency detailed potential adverse-event reporting violations at 15 hospitals in FDA-483 forms that were posted online by FDA to highlight the need to shift to an active, electronic based device surveillance system.
Reps. Mike Fitzpatrick, R-Pa., and cosponsor Louise Slaughter, D-N.Y., introduced medical device reform bills that would let courts consider product liability suits for PMA-approved devices and require physicians to report to FDA adverse events involving medtech products.