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T-17: An Evaluation of Global Over-The-Counter Medical Device Labeling Regulations
Rutgers, The State University of New Jersey United States
The objective of this study is to evaluate global over-the-counter (OTC) medical device labeling regulations in order to develop a universal guidance for health authorities and manufacturers on the minimum necessary requirements for OTC medical device labels.
After reviewing global medical device labeling guidelines, we developed a scoring system to highlight differences in the regulations. The scoring system, which evaluates content and user-friendliness, informed our recommendations for minimum labeling requirements.
Co-authors: Dr. Maggie Gandhi, Dr. Michael Toscani
The labeling on secondary packaging of medical devices communicates information for safe and effective use. As the innovation of OTC medical devices expands globally, adopting universal minimum labeling guidelines can aid manufacturers, health authorities, and patients. Universal guidelines can increase speed to market, internal efficiency, and profits for global manufacturers. Furthermore, universal regulations can reduce time needed for review by health authorities, and, in turn, provide patients with earlier access to new treatment options. Our recommendations can be applied to all countries that manufacture OTC medical devices. Health authorities can determine if they should increase their level of regulations to improve public health. Alternatively, they can determine if their restrictions are preventing patients from accessing new technologies in a timely manner. While most countries aligned on the content of the label, differences arose in the regulations surrounding symbols and indication for single use. These requirements may not be mandated because regulations have not been recently updated. As individual health authorities may be hesitant to adopt new guidelines, the purpose of our recommendations is to lay a foundation for harmonizing labeling requirements amongst various countries. Our recommendations for minimal labeling requirements include: name of the device, purpose, uses, warnings, directions for use, storage, expiration date, lot or batch number, name and address of the manufacturer, indication of sterility, formatting, and language requirements. As global labeling guidelines for OTC devices do not currently exist, these recommendations can serve as a guide for minimum labeling requirements; individual health authorities can choose to add additional regulations as they deem necessary.