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What is FDA Doing to Enforce the UDI Final Rule on Medical Device Manufacturers? What are the Consequences of Non-Compliance for the Provider?

Food and Drug Administration (FDA) is working very closely with all of the medical device manufacturers so there should be few problems with UDI Final Rule compliance. Some of the manufacturers have requested extensions of 30, 60, or 90 days for various reasons but not for extended time frames. All class III packages should now be received with Unique Device Identification (UDI).

Devices within the supply chain before September 24, 2014 are not required to be re-labeled. There are also exemptions from UDI for kit and non-sterile devices, as well as individually requested exemptions by companies. An assessment of devices that should be in the Global Unique Device Identification Database (GUDID) versus how many are in GUDID will result in a percent compliance. When assessing the need to be compliant for the goods in commercial distribution with the exceptions, there is adequate explanation for why there are less than the expected amounts of devices on GUDID. After taking this into account, report any issues to the FDA so that the FDA is aware of which manufacturers they need to work with for compliance.

With regards to the provider, at this time the FDA does not have a plan to reach out to providers and investigate why the information was not provided. Jean Sargent, Vice President of Healthcare Strategy and Implementation at USDM Life Sciences, has reason to believe that this could change with time. As a case in point, 15 years ago an FDA regulation stated that hospitals could no longer make their own medical devices then sterilize them unless they registered as a manufacturer with the FDA. The FDA began going into hospitals in order to make sure either all “manufacturing” was ceased or that the organization was approved by the FDA to manufacture products. In this case, FDA worked closely with The Joint Commission using Joint Commission’s surveyors to investigate the compliance. Jean assumes something like this could happen in relation to the current regulation.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.