From heart valves to blood glucose monitors to scalpels, medical devices help people live longer, healthier lives. A new effort to improve the identification of such devices is expected to increase standardization, efficiency and, most importantly, safety – but it does place an additional regulatory burden on device manufacturers.
As most medical device companies are aware, on Sept. 24, 2013, the U.S. Food and Drug Administration published its final rule on Unique Device Identification, or UDI. It requires most medical devices distributed in the United States to be labeled with specific information. Most devices will be required to display the UDI information on their label and packaging, and many also will have to place the information on the product itself. The information must be displayed in both plain text that a person can read and a machine-readable format such as a bar code.
“This is a landmark step for FDA,” wrote Dr. Jeffrey Shuren, the Director of FDA’s Center for Devices and Radiological Health, in a blog post explaining the new system. “UDI may be an acronym for Unique Device Identification, but what it really stands for is better patient health.”
Along with the new label requirements, the FDA is creating a database of information on medical devices, the Global Unique Device Identification Database, or GUDID. Device manufacturers will be required to submit substantial amounts of information on each of their individual device products to the FDA for entry into the database, which will be available to the public.
The new labels and informational database should enable devices to be identified more rapidly and precisely while allowing regulatory officials to better monitor the reporting of any adverse events. In the event a product must be recalled, the new system is expected to make a recall more efficient and thorough.
The FDA’s final rule is not a surprise to most medical device makers. The effort has been underway for years, and the government solicited input from industry representatives during the process of implementing the FDA medical device GUDID compliance. Still, many med device companies are now grappling with the reality of having to comply with unique device identifier regulations.
Manufacturers have from one to five years (from the issuing of the Final Rule on Sept. 24, 2013) to comply with both UDI label and GUDID submission regulations, depending upon the complexity of the device. The makers of Class III medical devices, for example, must comply within one year, giving them a deadline of Sept. 24, 2014. The makers of devices that are implantable, life-supporting or life-sustaining – such as implantable pacemakers or automated external defibrillators – must comply within two years, by Sept. 24, 2015. The makers of lower-risk devices will have more time to comply.
Compliance with these new regulations will be difficult, and a great deal of uncertainty still surrounds this major industry change. If your company is among those still in the early stage of FDA medical device UDI compliance, you are not alone. Here are steps you can take now to start moving forward:
- Review the FDA’s final rule and identify the requirements your life sciences medical device company must meet and the deadlines by which they must be met.
- Begin identifying and gathering the data required for your products’ labels and submissions to the GUDID.
- Evaluate which method of submission to the FDA’s database will be the best UDI solution for your company, taking into consideration cost, required labor and expertise.
- If considering an outsourced UDI solution, evaluate options from different vendors to decide which will be most cost effective while still ensuring full FDA compliance.
- Plot a timeline for compliance.
To learn more about how Reed Tech’s UDI compliance solution can ensure accurate compliance in a timely manner, contact us today.