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FDA to crack down on medical device safety

Accreditation Insider, January 5, 2016

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The Food and Drug Administration (FDA) will be taking a stronger stance on the reporting possible medical device hazards in 2016. The agency just released a draft guidance that will allow them to report early warnings signs associated with medical devices before the reports have been fully validated.    Device manufacturers and other interested parties have until February 29 to comment on the draft.  
Check out the draft on the Federal Register here. 
The FDA already provides warnings about safety hazards involving medical devices on their website. That said, they typically don’t release any information on problems, complications and deaths associated with a medical device until after the reports have been analyzed. The issue is that the agency receives hundreds of thousands of device safety reports in need of vetting each year.
“We believe there also is a need to notify the public about emerging signals that the agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the agency does not yet have specific recommendations,” the FDA said in the draft.
 This year alone the FDA has had to issue warnings and recalls for several medical devices such as endoscopes, sterilizers, intravascular medical devices, hip implants and defibrillators due to reported deaths and injuries.



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