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  • FDA Unveils Proposed Device Identification System, New Database

    The US Food and Drug Administration (FDA) announced Tuesday, 3 July its intent to implement a long-delayed Unique Device Identifier (UDI) rule, which would mandate most medical devices carry an identifier capable of allowing the device to be traced back to its point of origin. The UDI rule was mandated by the FDA Amendments Act (FDAAA) of 2007, but the rule has thus far failed to be implemented due to a confluence of factors including industry criticism and a stalled r...
  • User Fee Bills Would End Unique Device Identifier Stalemate

    A proposed rule by the US Food and Drug Administration (FDA) which would implement a so-called Unique Device Identification (UDI) system has been held up at the US Office of Management and Budget (OMB) for months , but could soon see rapid adoption under proposed user fee legislation in both the Senate and House of Representatives. The UDI rule, mandated by the FDA Amendments Act (FDAAA) of 2007, is intended to establish a uniform medical device identification system ...
  • Proposed Bill Would Mandate Passage of Device Identifier, Data Collection

    A new piece of legislation introduced in the House of Representatives by Rep. Lois Capps aims to expand postmarket tracking of medical devices and implement a mandate for the passage of a Unique Device Identification (UDI) rule by the end of 2012. The bill, the Sentinel Assurance for Effective Devices (SAED) Act of 2012 , was referred to the Energy and Commerce Committee on 7 May 2012. SAED would amend section 522 of the Federal Food, Drug and Cosmetic Act (FD&amp...
  • Report: FDA Developing UDI Barcode System for Medical Devices

    A report in The Wall Street Journal and The Gray Sheet indicate the US Food and Drug Administration (FDA) is working to develop and roll out a Unique Device Identification (UDI) system. The policy- long in development and long held-up at the White House's Office of Management and Budget (OMB)-was mandated under the Food and Drug Administration Amendments Act (FDAAA) and is intended to standardize how medical devices are tracked. FDA has been attempting to harmo...
  • As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

    A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources. St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," repo...
  • Proposed FDA Rules for UDIs, Laser Products Continue to Languish at OMB

    Two rules continue to languish at the US Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA), according to records. The Unique Device Identification (UDI) rule, which was mandated under the FDA Amendments Act of 2007, would establish a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier. The economically significant rule has been held up at OIRA since 11 July 2011...
  • Bill Would Address Medical Device Safety By Giving FDA Additional Authority

    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 sponso...