Over the past several years, the Food and Drug Administration (FDA) has been phasing in requirements for Unique Device Identifiers (UDI) to be displayed on various classes of medical devices. The UDI system identifies medical devices sold in the United States and is part of the information firms are required to submit to FDA’s Global Unique Device Identification Database (GUDID). The UDI Rule also requires standard formatting of certain dates on product labels.
The UDI must be printed in both easily readable plain text and machine-readable form, such as can be read by a bar code scanner, for example. Unless exempted, it must be displayed on device labels and packages.
Final guidance on UDIs for class I devices considered to be consumer health products and unclassified devices was posted on July 22, 2022. Enforcement of GUDID submission requirements was scheduled to take effect September 24, 2022; however, FDA extended the enforcement by an additional 75 days, now effective December 8, 2022.
FDA considers consumer health care products as 510(k)-exempt class I devices that are sold directly to consumers over-the-counter or online, that do not fall within one or more of the following categories:
- Class I reserved devices;
- Restricted devices;
- Implantable devices;
- Life-supporting or life-sustaining devices, and
- Certain devices distributed to professional healthcare facilities and intended for use by healthcare professionals only
It is critical that manufacturers and labelers understand the upcoming guidelines to ensure compliance where necessary. If you have any questions or concerns about your product’s UDI or whether your product is exempt, please call 410.220.2800 or contact us to discuss the appropriate course of action.
This blog/post is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular Benjamin L. England & Associates, LLC attorney contact for additional information.
