Bill Would Address Medical Device Safety By Giving FDA Additional Authority

Posted 16 March 2012 | By Alexander Gaffney, RAC 

A new bill introduced in the Senate would address medical device safety by giving the US Food and Drug Administration (FDA) additional authority to conduct postmarketing surveillance.

"Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market," said Senator Jeff Merkley, the bill's chief sponsor, in a statement.

The Ensuring Safe Medical Devices for Patients Act:

"Requires FDA to issue a final Unique Device Identifier (UDI) 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.  The UDI program was created nearly five years ago but FDA has not implemented it."

"Adds medical devices to the Sentinel post-marketing surveillance initiative, launched in 2008.  Sentinel is a national, integrated, electronic system which currently monitors prescription drug safety after FDA approval, once the drugs are being marketed to patients."

The bill may be wrong in at least one regard: FDA submitted the draft of its UDI rule this past year, according to reports in Politico. The draft has reportedly been stalled at the Office of Management and Budget, which approves all regulations before they are released in the Federal Register.

The bill is also similar to one released in December by many of the same Senators, the Medical Device Patient Safety Act.


Read more:

Press statement - Senators Introduce Bipartisan Effort To Make Medical Devices Safer

Regulatory Focus - Politico: FDA Efforts to Create International Uniform Device Code Stalled by OMB

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