Medical Devices Law & Industry Report provides complete in-depth, interdisciplinary news coverage of all major developments in the rapidly changing medical...
Saying that the Food and Drug Administration has missed a statutory deadline, interest groups July 8 urged the White House to wrap up its review of a final safety rule on medical device identifiers.
The Pew Charitable Trusts, a research organization, and the Premier healthcare alliance, which represents purchasers of devices, asked the White House Office of Management and Budget to finalize the FDA rule, which they say is necessary for conducting safety surveillance of medical devices to improve patient safety and quality of care.
The groups said in their July 8 letter to Sylvia Mathews Burwell, OMB's director, that the unique device identifier, or UDI, system “will serve as the cornerstone of improving medical device safety and quality.” OMB received the FDA final rule on UDI on June 11, according to an OMB website (http://www.reginfo.gov) (7 MELR 411, 6/26/13).
Pew and Premier said recent recalls and “failures of medical devices--including metal-on-metal hips and cardiac defibrillator leads--clearly demonstrate the need to more quickly identify problematic products before they are used in hundreds of thousands of U.S. patients.” They also said that the Government Accountability Office found that more than half of medical device recalls conclude “without the correction or removal from the market of all defective products.” An improved device identification system will address these problems, the groups added.
UDIs were first required under a 2007 law, but that law did not establish a deadline for FDA to issue a regulation. A law signed by President Obama in July (Section 614 of the FDA Safety and Innovation Act) established a schedule for issuing a proposed and final UDI rule. A proposed rule was issued in summer 2012 (6 MELR 442, 7/11/12).
The July 8 letter said Section 614 required such a rule to be finalized by June 19. The groups pointed out that FDA was required to issue the final rule within six months of the closing of the comment period on the proposal.
In the letter, Pew and Premier said FDA “has identified UDI as a central component to the national medical device postmarket safety plan, which committed the agency to release the UDI regulations by the end of June.”
In addition, the groups said the final UDI rule “is essential in order for the Office of the National Coordinator for Health Information Technology and the Centers for Medicare & Medicaid Services to consider the capture of device identifiers into the next updates to electronic health record standards and meaningful use criteria. The agencies intend to commence rulemaking next year on these topics based on input from federal advisory committees, which are already compiling recommendations and have begun discussions on UDI.”
The letter is at http://op.bna.com/hl.nsf/r?Open=bbrk-99emcg.
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