What are the potential consequences for medical device manufacturers not following through with product data submissions and labeling requirements? In a recent inspection, violations were identified regarding a manufacturer’s Unique Device Identification (UDI) compliance and data submission to FDA GUDID.
Violation 1: Failure to Include UDIs on Device Labels
According to FDA regulations, medical device labels must bear a UDI that meets the requirements of 21 CFR part 801, subpart B, and 21 CFR part 830. However, the inspection revealed that several devices manufactured after September 24, 2016, did not include a UDI on their labels.
Repeat Observation and Required Corrective Actions:
This violation is a repeat observation from a previous FDA inspection. Although the company committed to generating UDIs and updating labels during the recent inspection, no evidence of implementation has been provided. The manufacturer must address this violation promptly by verifying identification and traceability controls, updating labeling, providing training records, revising SOPs, and implementing label verification procedures and recordkeeping.
Violation 2: Failure to Submit Required Data to GUDID
As a ‘labeler’ of medical devices, the manufacturer has an obligation to submit specific data to FDA Global Unique Device Identification Database (GUDID) as required by 21 CFR 830.300(a). However, the inspection revealed several devices had not registered in the GUDID.
Repeat Observation and Required Corrective Actions:
Like the previous violation, failure to submit the required information to GUDID is a repeat observation from a previous FDA inspection. Although the manufacturer committed to registering UDIs to GUDID, no updates or records of submissions have been provided. The manufacturer must promptly address this violation by registering the required information for each version or model of the devices.
Consequences of Non-Compliance:
Failure to adequately address these violations may result in regulatory action, including seizure, injunction, and civil money penalties. Compliance with FDA regulations is also a factor considered by other federal agencies when awarding contracts. Furthermore, non-compliance may delay the approval of premarket applications for Class III devices, and requests for Certificates to Foreign Governments (CFG) may not be granted.
Conclusion:
Following through with data submissions and labeling requirements per FDA regulations is critical for medical device manufacturers to ensure patient safety and meet legal requirements. The violations related to FDA GUDID identified in the recent inspection must be addressed. The manufacturer should take corrective actions, including updating labels with UDIs, registering devices and required data with GUDID, and implementing appropriate quality control measures. Failure to address these violations may result in severe regulatory consequences. Prioritizing a commitment to regulatory compliance and patient safety benefits everyone.
At Reed Tech, we specialize in medical device product data requirements to global health authorities. UDI can become overwhelming without experienced guidance. If we can help with questions about FDA, EUDAMED or other emerging regulators, don’t hesitate to reach out. Our team of experts can help you set a UDI strategy for initial data submissions and ongoing maintenance.
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