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FDA UDI Enforcement: 4 Things to Consider


While recently speaking with a regulatory manager who works at a medical device manufacturer with a large Class II product portfolio, I was surprised to hear that his organization was not concerned about meeting the FDA’s UDI requirements by the September 24 deadline. He confided he is personally worried about the potential consequences, but upper management was pretty sure the FDA would not take a hard stance on enforcing UDI requirements anytime soon. The CEO thought the risk of noncompliance simply did not justify the investment of resources required to comply by the deadline.

A small, but not insignificant, number of industry members seem to hold the same outlook. It’s important to point out that this view is not, however, one held by the FDA. Several key points to keep in mind on your journey to UDI compliance:

1) UDI is ultimately about improving patient safety, a goal that sits at the very center of the FDA’s purpose as a federal agency. It is reasonable to assume it would want to enforce an initiative it has devoted significant resources to implementing over several years.

2) The FDA has a mandate to inspect Class III and II medical device manufacturers every two years, making an inspection an eventuality, not a possibility. UDI is one of the things inspectors are looking for. FDA has already cited failure to comply with UDI requirements in a warning letter as early as last July, so UDI enforcement has already begun.

3) The FDA has publicly stated and reinforced on several occasions that it has the authority to consider UDI as part of the requirements of labeling and that failure to meet labeling standards may be considered misbranding. Misbranding consequences can be severe, including warning letters and product detainment or seizure.

4) Reed Tech has witnessed many enforcement actions and frequent product detainments by the FDA for failure of pharma companies to meet electronic drug listing submission requirements. We should expect the agency to follow a similar pattern of enforcement for UDI.

No one wants to be responsible for receiving a warning letter (or worse) from the FDA. To everyone facing the September deadline, take a look at the FDA’s track record and consider the risk to your company. The fact that almost all Class II med device companies are in the process of complying with the mandate should alert you to the necessity of moving forward.

The deadline for Class II labelers is very soon, fewer than 80 working days away. For help, watch a free on demand webinar on how to meet UDI requirements by the deadline with UDI expert Gary Saner of Reed Tech. You can also contact us. We will gladly get you on the path to compliance.

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