Four senators today introduced the bipartisan Ensuring Safe Medical Devices for Patients Act, which would allow the FDA to tighten its oversight of medical devices, according to a KTVZ report.
The bill would require the FDA to issue a final Unique Device Identifier rule mandating that all device implants carry a unique identifying number so that products can be easily tracked upon distribution and once they are being used with patients. Though the UDI program was created five years ago, the FDA has not yet implemented it and would be required to do so by the end of 2012.
The bill would also add medical devices to the Sentinel initiative, a nationally integrated electronic system that monitors the safety of FDA-approved prescription drug being marketed to patients.
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The bill would require the FDA to issue a final Unique Device Identifier rule mandating that all device implants carry a unique identifying number so that products can be easily tracked upon distribution and once they are being used with patients. Though the UDI program was created five years ago, the FDA has not yet implemented it and would be required to do so by the end of 2012.
The bill would also add medical devices to the Sentinel initiative, a nationally integrated electronic system that monitors the safety of FDA-approved prescription drug being marketed to patients.
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