• Regulatory NewsRegulatory News

    FDA Pushes Back Enforcement of UDI Rule Provisions

    The US Food and Drug Administration (FDA) on Monday finalized guidance that makes clear the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time. The shift in enforcement comes as FDA says it wants to make sure it gives companies enough time to make changes to the medical device reimbursement, supply chain and procurement systems and proces...
  • Regulatory NewsRegulatory News

    UDI Form and Content: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Monday released new draft guidance to help define the expected content and forms of the Unique Device Identifier (UDI), to assist both medical device labelers and FDA-accredited issuing agencies in ensuring that UDIs are in compliance with the UDI Rule. Background A UDI is composed of (1) a device identifier (DI), (2) typically one or more production identifiers (PIs) when included on the device label, and (3) the data del...
  • Regulatory NewsRegulatory News

    UDI Compliance: What's Coming From FDA in 2016

    Class II medical devices will follow Class III and implanted devices later this year when they come into compliance with unique device identifier (UDI) regulations beginning in September, officials from the US Food and Drug Administration (FDA) told the UDI Conference in Baltimore on Monday. Under the UDI rule, FDA established a phased, risk-based, approach to UDIs, which are tracking tags used to improve the safety of medical devices. The rule began applying to Class II...
  • Regulatory NewsRegulatory News

    Pew: Insurance Claims Must Include UDIs to Track Device Safety

    The Pew Charitable Trusts says that adding unique device identifiers (UDIs) to insurance claims forms is critical to the success of several federal initiatives to improve medical device safety and patient care. Dr. Josh Rising, director of healthcare programs at Pew, told Focus on Wednesday about his organization's efforts to improve device surveillance and how incorporating UDIs into claims forms can aid those efforts. "The goal of Pew's medical device project is to ...
  • Regulatory NewsRegulatory News

    Senators Grill CMS on Incorporating UDIs Into Insurance Claims Forms

    Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA) questioned the Centers for Medicare and Medicaid Services' (CMS) opposition to incorporating the unique device identifier (UDI) for medical devices into insurance claims forms. By not adding UDIs to insurance claims forms, Warren and Grassley warn that Medicare is making it more difficult to monitor device safety, which has resulted in millions of claims that could have been avoided with better monitoring. In ...
  • Regulatory NewsRegulatory News

    FDA Extends Deadline for Some UDI Requirements for Medical Devices

    The US Food and Drug Administration (FDA) is giving manufacturers more time to remove drug codes from certain medical device labels in compliance with unique device identifier (UDI) requirements to avoid disrupting patient access to devices. Specifically, the agency says it will enforce a statutory prohibition on National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers for device labels and packaging for certain devices. In 2013, FDA issued its fin...
  • Regulatory NewsRegulatory News

    How Do Two or More Packaged Devices Need to Comply With the UDI Rule? FDA Explains

    The US Food and Drug Administration (FDA) is looking to shed more light on cases where two or more medical devices packaged together, in what the agency calls a “convenience kit,” would need to comply with unique device identifier (UDI) labeling requirements. According to the draft guidance, the term convenience kit, which the guidance attempts to adjust, “applies solely to two or more different medical devices packaged together for the convenience of the user where they...
  • Regulatory NewsRegulatory News

    Industry Weighs Integration of UDIs Into Medical Device Registry Network

    The Advanced Medical Technology Association (AdvaMed) is at odds with a government task force over how unique device identifiers (UDI) could be used in a proposal for a coordinated registry network for medical devices. Background In 2012, the US Food and Drug Administration (FDA) issued a report, Strengthening Our National System for Medical Device Postmarket Surveillance , which detailed the agency's vision for improving device surveillance. One of the report's...
  • Regulatory NewsRegulatory News

    UDIs for Implantable Devices Now Included in Common Clinical Data Set

    For the first time ever, unique device identifiers (UDIs) will have to be included as part of a set of common clinical data intended to help physicians better track patients' implanted devices. Background Back in 2013, a final rule from the US Food and Drug Administration (FDA) mandated that most devices marketed in the US will eventually be required to be marked with a UDI to distinguish devices from one another and make them easier to track, particularly for...
  • Regulatory NewsRegulatory News

    FDA Explains How Medical Device Companies Can Comply With UDI Marking Requirements

    New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify the process of "marking" a medical device with a Unique Device Identifier (UDI). Background Under a final rule released in September 2013, most devices marketed in the US will eventually be required to be marked with a UDI—an identifying mark used to distinguish devices from one another and make them easier to track. A UDI is composed of two parts: a device identifier that corresp...
  • Feature ArticlesFeature Articles

    Six Recommendations Regarding Upcoming UDI Compliance Dates

    As 2014 fades into memory, the medical device industry faces the next phases of Unique Device Identification (UDI) implementation for devices marketed in the US. September 2015 is the deadline for UDI labeling implementation and data submissions for Implantable, Life-Supporting and Life-Sustaining (I/LS/LS) devices with the remainder of Class II devices following in 2016. 1 The Class III device UDI compliance date passed on 24 September 2014. Overall, implementation of ...
  • Regulatory NewsRegulatory News

    FDA Releases Vast Trove of Medical Device Data in Hopes of Transforming Healthcare Delivery

    The US Food and Drug Administration (FDA) is opening up one of its vast treasure troves of data to the public in the hopes of improving the way medical devices are integrated into the healthcare delivery system. Background The latest release involves data related to FDA's unique device identification (UDI) program. The program, established by regulation in September 2013 , requires most medical device manufacturers to affix identifying information to each device ...