The president and CEO of the Advanced Medical Technology Association has issued a statement on the introduction of the "Ensuring Safe Medical Devices for Patients" Act.
The bill, introduced by Senators Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wisc.), would require FDA to issue a final Unique Device Identifier rule by the end of 2012, requiring implantable devices to carry a unique numerical identifier so products can be tracked through the distribution chain and once they are being used with patients. It would also add medical devices to the Sentinel post-marketing surveillance initiative, a national, integrated, electronic system which currently monitors prescription drug safety after FDA approval and marketing to patients, according to a news release from Sen. Kohl.
"We very much appreciate the senators' interest in the UDI and share their interest in ensuring the safety of medical devices," said AdvaMed President and CEO Stephen J. Ubl, in the statement. "America's medical device manufacturers have long-supported the appropriate implementation and use of a UDI system and believe it can play an important role in advancing patient safety. The appropriate development and use of UDI and the post-market risk identification and analysis system known as Sentinel should further enhance FDA's already robust post-market authorities."
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