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  • Regulatory NewsRegulatory News

    US FDA Amends eMDR Rules to align with Unique Device Identification Program

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US medical device regulators at the Food and Drug Administration (FDA) have issued correcting amendments  to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system. All changes will affect federal regulation 21 CFR Part...
  • Feature ArticlesFeature Articles

    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 ...
  • Regulatory NewsRegulatory News

    FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants

    The US Food and Drug Administration (FDA) is granting labelers of certain types of implantable medical devices a temporary reprieve from its upcoming requirements that all medical device products be marked with a unique device identifier (UDI) meant to make the devices safer. 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 ...
  • Regulatory NewsRegulatory News

    Australian Government Proposes Bypassing TGA for Medical Devices with CE Marking

    Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies. The proposal, part of a new government  position paper pushing innovation and competitiveness issues, wou...
  • Feature ArticlesFeature Articles

    Medical Device Regulatory Update: Usability, UDI and RoHS

    What do human factors engineering (HFE), unique device identifiers (UDIs) and restriction of hazardous substances (RoHS) have in common? More than one may think. At the recent 2014 RAPS San Francisco Bay Area Chapter’s annual educational collaboration with the ASQ Northern California Biomedical Division, attendees gathered to enhance their understanding of HFE, the requirements for UDI and the impact of the RoHS 2 Directive 2011/65/EU 1 aimed at devices currently under D...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • US Health IT Officials Call for Integration of FDA's Unique Device Identification with eHealth Records

    The Office of the National Coordinator (ONC), a US health technology implementation advocate, has announced a new proposed rule that would advocate for the integration of the US Food and Drug Administration's (FDA) recent Unique Device Identification (UDI) rule with electronic health records (EHRs). 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 regulator...
  • Third Company Obtains Accreditation Under FDA's Unique Device Identification Program

    Medical device manufacturers now have a third accredited option from which to ensure compliance with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, regulators announced last week. Background FDA released its final UDI rule in September 2013, reflecting a wide range of changes called for by industry. The rule, at its most basic, requires most medical devices to be given a unique identifying mark. The system has a number of a...
  • Device Manufacturers Get New Option to Ensure Compliance with UDI Rule

    Medical device manufacturers looking to comply with the US Food and Drug Administration's (FDA) new Unique Device Identification (UDI) rule will now have a second accrediting agency from which to obtain an identifying mark. Background FDA released its final UDI rule in September 2013, reflecting a wide range of changes called for by industry. The rule, at its most basic, requires most medical devices to be given a unique identifying mark. The system has a number of all...
  • Jay Crowley, Author of FDA's UDI Rule, to Leave Agency for Industry Next Week

    Jay Crowley, the US Food and Drug Administration's (FDA) author of the Unique Device Identification (UDI) rule and a longtime employee of the agency, will soon retire to join industry, agency officials confirmed today. The news first broke on 19 December 2013, when USDM Life Sciences, a global regulatory consulting firm, announced that it had hired Crowley as its Vice President of its UDI practice. "There is nobody more qualified to help our medical device clients bec...