There have been many questions surrounding the enforcement of the Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule. Will it be enforced? How rigidly will it be enforced? What will the penalties be?
And, most commonly asked, is it worth it to become UDI compliant?
There are many benefits to UDI. The Unique Device Identification System will benefit healthcare providers, manufacturers, hospitals, healthcare professionals, and patients by enabling:
However, implementing UDI does cost money, and a large price tag tends to make companies drag their heels. Some organizations are betting that the FDA does not enforce Unique Device Identification and have decided to ignore the regulation.
Why the FDA Will Enforce UDI
There are several compelling reasons the FDA will be enforcing UDI. Consider the following facts.
Unique Device Identification is viewed as a key pillar of patient safety. UDI is laying the groundwork for a global system that will track medical devices, help prevent counterfeits and mix-ups, and uncover faulty medical devices. The goal of UDI is, at its core, to save lives. As patient safety exists at the very core of the FDA's purpose for existence, that makes it unlikely UDI enforcement will be neglected.
The FDA has invested enormous resources in UDI. This is not a trivial rule that the FDA threw together overnight. The FDA has invested years of its time, a significant amount of money, and a lot of effort into the creation of the UDI legislation. A little more time and effort spent enforcing the regulation is a small pledge compared to what the FDA has already spent on UDI.
The FDA inspects Class II and III medical device manufacturers every two years. This means medical devices will be inspected, not might be inspected. It's easy for the FDA to look for UDI compliance when they are already scheduled to inspect medical device manufacturers for compliance on a regular basis. Unique Device Identification has been added to the list of compliance issues that inspectors will be looking for. According to a warning letter issued in July, the FDA has already begun issuing citations for UDI non-compliance.
An article written by Reed Tech stated that the FDA has frequently penalized non-compliant companies with citations and product detainments. The Food and Drug Administration is not an agency without teeth. Historically, they do not implement large legislative changes, such as UDI, and not follow up with the proper amount of enforcement. Reed Tech fully expects the FDA to "follow a similar pattern of enforcement for UDI."
The FDA has a mandate from Congress to implement UDI, which means Unique Device Identification has backing from the highest levels of government. This is not an idea that was pushed through by a small group of people. Prominent individuals, think tanks, and medical groups came together from across the country in order to ensure that Unique Device Identification became a reality. UDI is not an idea that is going to fade away anytime soon.
Possible Penalties of UDI Non-Compliance
Penalties include, but are not limited to:
The FDA has announced that non-compliance with Unique Device Identification could be considered misbranding. This paves the road for serious penalties.
As stated in the federal register, “Devices for which there has been a failure or refusal to furnish any material or information required by or under section 519 of the FD&C Act respecting the device are misbranded under section 502(t)(2) of the FD&C Act. The failure or refusal to furnish any material or information required by or under section 519 of the FD&C Act is a prohibited act under section 301(q) (1) (B) of the FD&C Act. Potential enforcement actions for violations of UDI requirements include seizure, injunction, and civil and criminal penalties.”
A non-compliant company could even be barred from selling their medical devices in the United States or across state lines. This suspension of a company's distribution could result in lost sales and harm to the company's reputation. Reputation takes decades to rebuild, which means a hit to a business' reputation could last years if not decades.
Leslie Gaines-Ross, author of A Guide to Building CEO Reputation and Company Success, says, “I don’t think anyone is safe from losing their reputation. In certain industries, it’s 90% trust and reputation…It’s like health care companies, or pharmaceutical companies, airlines. If you don’t trust an airline, you’re not going to fly it.”
