The FDA defines a medical device as follows:
...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
The regulations for UDI were included in a bill passed by the U.S. Congress in 2013, called the Food and Drug Administration Safety and Innovation Act (FDASIA).
In the United States, the FDA is implementing UDI regulations in response to the urgent need to improve medical device safety and reporting of adverse events, or even death, related to the implantation of medical devices.
This bill, enacted into law, also empowers the FDA to create a safe and transparent record of important data pertaining to each and every medical device marketed and sold in the United States in the GUDID. The GUDID expedites the timely removal and recall of faulty medical devices, without which quick, accurate and reliable tracking through the supply chain from manufacturer to patient would be unlikely. The GUDID will also serve as a valuable research resource for manufacturers, caregivers, and patients regarding positive medical outcomes.
These new labeling regulations are being phased in through 2020 in a concerted effort to provide a comprehensive methodology for medical practitioners, caregivers, and patients to track and monitor the safety and efficacy of medical devices and the related positive medical outcomes, as well as to target unapproved medical devices that work their way into the supply chain through counterfeiting and gray market diversion.
The primary identifier of each medical device must be issued by one of two agencies that meet the FDA standards: either GS1 or the Health Industry Business Communication Council (HIBCC), and then the UDI must be encoded in a labeling barcode and registered in the GUDID.
The European Union recently updated its version of UDI with the adoption of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), which contain a series of important improvements to modernize its current system. Companies doing business with the EU will have to comply with these new requirements by 2020 and 2022. Visit the European Commission site for more information on these regulations.
How Loftware Can Help:
Loftware is a certified GS1 partner and provides all that is necessary to meet the specific labeling needs of medical device manufacturers. By supporting validated labeling requirements, eSignature, and workflow functionality, Loftware delivers an end-to-end supply chain labeling solution.
Integrate to Your Sources of Truth in Labeling
Loftware sources label data directly from your enterprise business applications and incorporates business rules for efficient, accurate labeling automation.
Flexibly Meet Your Regulatory Label Requirements
Loftware enables you to rapidly respond to changing regional and international regulatory requirements for labeling, including those mandated by the FDA's UDI Systems.
Meet Your Customer-Specific and Private Brand Requirements
With Loftware, you can quickly respond to customer requirements, including private branding, and reduce the long process of making complex labeling changes to a matter of just a few days.
For more information on how Loftware Enterprise Labeling Solutions can reliably streamline labeling for UDI and many other labeling challenges, please contact one of our Medical Device Industry Specialists.