• IMDRF Finalizes UDI Rule, Five Other Device-Related Documents

    The International Medical Device Regulators Forum (IMDRF) has announced the finalization of six documents pertaining to the marking of devices with unique identifiers, standardized definitions for medical software and extensive requirements for auditors participating in the single audit program. The IMDRF, launched in early 2013, is the regulators-only successor to the Global Harmonization Task Force (GHTF), a harmonization group that disbanded in 2012. Its current membe...
  • Industry Digs into Details of UDI Database Guidance in Comments to FDA

    Many of the medical device industry's biggest names have begun to weigh in on a new proposal from the US Food and Drug Administration (FDA) to launch a database intended to facilitate the operation of its Unique Device Identification (UDI) rule, offering a wide range of proposed changes. Background A  UDI  is, as its name implies, a system of identifying each medical device using a specific system. The system has a number of allures for regulators. "The uniqu...
  • Was OMB's Lengthy Review of the UDI Rule Worth the Wait?

    It's not yet clear how the US Food and Drug Administration's (FDA) unique device identification (UDI) rule will be remembered. After all, it has not yet been implemented. But if the rule is remembered for something, it may well be for the lengthy process it went through to eventually obtain approval, as well as the extensive and unexplained delays it went through along the way. Now, for the first time, the public is getting something of a glimpse at the behind-the-scen...
  • FDA Releases Unique Device Identification Rule, Reflecting Dozens of Changes Sought by Industry

    In a highly anticipated move, the US Food and Drug Administration (FDA) has announced the final release of the Unique Device Identification (UDI) rule, reflecting a number of changes called for by industry. Background A UDI is, as its name implies, a system of identifying each medical device using a specific system. The system has a number of allures for regulators. "The unique device identification system will help reduce medical errors, and will allow FDA, the h...
  • Interview: FDA's UDI Architect Jay Crowley on the Agency's Approach to UDI and Pending Changes

    • 02 May 2013
    The US Food and Drug Administration (FDA) is, like many device regulatory bodies around the world, preparing to implement a huge overhaul of its medical device systems. Known as the Unique Device Identification (UDI) rule, the US regulator wants to build a system that allows for safer, more accountable medical devices. But that process, which is global in scale, is not without significant challenges. In the wake of a flurry of UDI activity in recent weeks, we called up F...
  • IMDRF Issues Major Guidance Outlining UDI Framework for Medical Devices

    The International Medical Device Regulators' Forum (IMDRF), the regulators-only medical device harmonization group, has released a long-awaited major medical device proposal for industry comment regarding a Unique Device Identification (UDI) rule. IMDRF Background IMDRF launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), which disbanded in December 2012 after its device regulatory members decided to split off and form their o...
  • European Commission Releases Harmonized UDI Framework

    The European Commission (EC) has announced the release of its recommendation on a framework for a unique device identification (UDI) system for medical devices marketed in the EU, bringing the country in line with similar proposals since released by the US Food and Drug Administration (FDA) and under consideration by the International Medical Device Regulators' Forum. Background A UDI is essentially an identifying mark by which someone-particularly a regulatory authorit...
  • FDA Accelerates Implementation Deadline of UDI Rule for Certain Higher-Risk Devices

    The US Food and Drug Administration (FDA) has unveiled a new amendment to its proposed unique device identification (UDI) rule that would accelerate the implementation schedule of the rule for certain types of medical devices. The rule has long been under consideration by both FDA and stakeholders. It was required under the 2007 FDA Amendments Act (FDAAA) , and was intended to standardize how medical device products are tracked and traced by requiring all devices be...
  • Medical Device Group Calls for More Transparency on Proposed Naming Conventions

    A medical device-focused scientific advocacy group is calling on the US Food and Drug Administration (FDA) to make changes to a recently proposed regulation set to make big changes to the way medical devices are tracked after being introduced to the market. In a statement on 11 October, the Emergency Care Research (ECRI) Institute said it is "concerned" about FDA's Unique Device Identification (UDI), set to come into effect within the next year. The rule -long delayed...
  • Feature ArticlesFeature Articles

    FDA Acts on Long-Delayed UDI Rule

    On 2 July 2012, the US Food and Drug Administration (FDA) published the eagerly awaited proposed rule requiring a unique device identifier (UDI) be placed on the label and packaging of marketed medical devices. 1 The UDI rule was mandated under the Food and Drug Administration Amendments Act of 2007, but has been delayed numerous times. There has been an ongoing debate about the list of mandatory information elements and the cost and merits of potential bar-code syst...
  • Extension Proposed for Comment Period on Important Medical Device Rule

    The US Food and Drug Administration (FDA) is proposing to extend the comment period on a proposed rule that would overhaul the way medical devices are overseen by regulators, it has announced. In July 2012, FDA released a long-awaited rule on a Unique Device Identification (UDI) system which would require most medical devices to carry an identification number and/or barcode capable of tracing the device back to its point of origin. Though the rule was mandated under l...
  • FDA Lays out Plan for National Medical Device Surveillance System

    On the eve of several public meetings aimed at reworking the US Food and Drug Administration's (FDA) medical device postmarket surveillance system, the agency has released a new plan it says offers its own roadmap on how to improve safety monitoring of potentially dangerous devices. The report, entitled, " Strengthening our National System for Medical Device Postmarket Surveillance ," proposes four changes to be made to the current system of postmarket surveillance: th...