The U.S. Food and Drug Administration has issued what the agency is describing as a “first-of-a-kind guidance” to help medical device manufacturers get through the review process for new devices.
The FDA is issuing the document, titled “Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” to address problems that have come up recently as a result of the agency’s approval process.
An FDA spokeswoman has been quoted as saying: “The devices center identified several problems in our pre-market review programs, and started to address those problems to assure that they are predictable, consistent, transparent and efficient.”
Prominent consumer groups and public safety advocates have recently called on the FDA to change a process allowing untested medical devices to make it onto the market.
They specifically take issue with a fast-track process known as pre-market notification, or 510(k), which allows devices that were never safety tested in humans to be approved because the manufacturers claimed they’re “similar” to devices already on the market.
The process led to the approval of metal-on-metal hip implants that Johnson & Johnson subsidiary DePuy recalled in 2010 due to their failure at a higher-than-expected rate, and their tendency to leave toxic metal debris in the bodies of patients.
It also led to the approval of surgical mesh implants, used to treat urinary incontinence and pelvic organ prolapse, which have prompted thousands of lawsuits due to their tendency to fail and cause health problems such as severe, persistent pain and organ perforation.
See the FDA document here: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf.