• Regulatory NewsRegulatory News

    FDA nixes GUDID submission requirements for class I consumer healthcare devices

    Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the US Food and Drug Administration’s (FDA) Global Unique Device Identification Database (GUDID) submission requirements under a draft guidance issued on Wednesday.   Under the agency's unique device identification (UDI) compliance policy guidance issued in June 2020, class I devices, other than implantable, life-supporting, and life-sustaini...
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    FDA Finalizes Guidance on Convenience Kit UDI Marking

    The US Food and Drug Administration (FDA) issued final guidance Thursday to provide medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits. The guidance finalized the 2016 draft version of the document, developed by FDA’s Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research. Combination products and in vitro diagnostics subject to labeling requirements fall ou...
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    FDA Grants Third Extension of UDI Compliance Date to Soft Contact Lens Labelers

    The US Food and Drug Administration (FDA) last week granted a third extension for soft contact lens labelers yet to comply with the requirements of the Unique Device Identification (UDI) system because of the agency’s resource limitations. Background In September 2013, FDA published a final rule creating a UDI system and outlining labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the US, unless a...
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    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...
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    FDA Pushes GUDID Compliance Back for Some Devices Due to Security Flaw

    After discovering a security flaw in the Global Unique Device Identification Database (GUDID), the US Food and Drug Administration (FDA) is giving device makers an additional month to comply with new labeling and data submission requirements. Background In 2013, a new set of regulations required companies to comply with new labeling and data submission requirements, with staggered compliance dates based on device classification. Specifically, companies distributing dev...
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    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 ...
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    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 ...
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    US UDI/GUDID Submission Deadlines: What Medical Device Manufacturers Need to Know

    The US Food and Drug Administration (FDA) Unique Device Identification (UDI) final rule, 1 released 24 September 2013, requires medical devices distributed in the US to include a UDI value on the device label and package. The UDI combines a static device identifier, assigned by an FDA-approved issuing agency, and a series of dynamic production identifiers, taken from information on the device’s label. The rule also requires medical device manufacturers to submit ...
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    FDA Extends UDI Compliance Date for Most Contact Lenses

    Some medical device manufacturers will have an additional year to comply with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, a 2013 regulation intended to allow regulators to exercise greater oversight of the device 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 h...
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    FDA Unveils Final Details about Medical Device Tracking System

    Regulators with the US Food and Drug Administration (FDA) have released a second, substantially more complete guidance document indicating how its Global Unique Device Identification Database (GUDID), an integral part of the agency's pending oversight of the Unique Device Identification (UDI) system, works. Background Under FDA's UDI regulation, medical device manufacturers will soon have to start affixing device identifiers and production identifiers to most devi...
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    FDA Releases Final, Slimmed-Down GUDID Guidance, Leaving Many Details for Later

    The US Food and Drug Administration (FDA) has finalized a guidance document intended to outline the appropriate use of its Global Unique Device Identification Database (GUDID), an integral part of its attempt to overhaul how medical devices are kept track of in the US. But not included in the final guidance is more than half of what the agency originally set out to define. Background A Unique Device Identification (UDI) is, as its name implies, a system of identif...