The compliance date for device labelers to place Unique Device Identifiers (UDIs) on their Class II devices is approaching quickly. Under the U.S. Food and Drug Administration (FDA) final rule, Class II devices must be labeled with UDIs starting September 24, 2016. FDA consulting firm Registrar Corp is providing tips to help labelers of Class II devices meet the impending deadline.
Tip 1: Determine the Labeler
FDA puts responsibility for UDI compliance on the “labeler” of a medical device. FDA’s definition of a labeler can confuse companies trying to comply.
Typically, the labeler is the owner of the brand. When the manufacturer does not own the brand, the manufacturer is likely not the labeler.
For example, if RegMed buys catheters from CBI Medical Products and markets the devices under RegMed’s brand, RegMed would likely be considered the labeler of the catheters.
Tip 2: Start Immediately
If you determine you are responsible for complying with FDA’s UDI requirements, it’s prudent to start as soon as possible. Many aspects of UDI compliance can take substantial time to accomplish.
For example, FDA requires that device facilities obtain a DUNS number for UDI purposes. DUNS numbers are free to obtain, but it can take Dun and Bradstreet weeks to issue a new number.
Registrar Corp can help facilities obtain a DUNS number free of charge. Device labelers also are required to identify a Global Medical Device Nomenclature (GMDN) for each device they submit to FDA’s Global Unique Device Identification Database (GUDID).
Tip 3: Practice Makes Perfect
Submitting data into FDA’s GUDID can be time consuming and complicated. FDA recommends that labelers using the agency’s web interface or the HL7 SPL method familiarize themselves with the system before submitting.
Web interface users may create draft submissions which are not visible to FDA. Alternatively, Registrar Corp can submit device data to FDA’s GUDID on behalf of a labeler.
Tip 4: Appoint a Knowledgeable Regulatory Contact
FDA requires device labelers to designate a Regulatory Contact when creating a GUDID account. FDA will contact this individual with questions regarding GUDID submissions as well as compliance and regulatory issues.
The Regulatory Contact speaks on behalf of the company, so it’s important to designate a professional familiar with FDA’s UDI rule. Registrar Corp employs several UDI specialists and can act as a company’s Regulatory Contact. As a company’s Regulatory Contact, Registrar Corp will setup the company’s GUDID account, help determine the UDI requirements applicable to the company’s specific devices, and facilitate communication between FDA and the company.