Combination Product Industry News & Guidance

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Applying cGMPs for Combination Products to Ophthalmic Devices

You may be seeing evolving regulatory requirements about e-labeling, and beginning to weigh the benefits of ditching paper IFUs for digital versions that could reduce costs, user error, and waste due to limited shelf life or the need for updated content while allowing for additional useful formats such as audio- or video-based information. Asia and Australia are setting the trend, with Europe on its heels, but note that the ability to capitalize on e-labeling for the more complex category of combination products is still a ways away.

Even for ‘standalone’ medical devices, electronic labeling is a complicated topic. The allowance to provide electronic labeling completely in lieu of printed versions has constraints (jurisdiction, user groups, device classification, etc.). Companies interested in making the switch to digital must be prepared to understand applicable law and regulations, which differs by country and will likely have to utilize a mix of electronic and paper instructions across the globe. The complexity increases considerably when there is both a device constituent and a drug constituent – even more so when the product is primarily regulated as drug-led. The drug constituent will have significantly more stringent labeling requirements which are either layered on top of, or take precedence over, any device constituent labeling requirements.

In many countries, particularly in the United States, paper copies of labeling are still required by law. There has been lobbying to change that in the US, but Congress must pass new law for e-labeling to be a viable paper-replacement option for most drug delivery combination products. For now, this remains a highly complex topic for combination product developers, that requires deep analysis and understanding before implementation. To take a deeper dive into the status of e-labeling, check out this article.

Bottom line advice from Suttons Creek: Staying ahead of the curve and dipping into some of the user benefits of e-labeling for competitive advantage may be reason for some companies to start down this newly (and slowly) forming road. However, it will be a while until e-labeling becomes a cost-saving global solution. If you want to weigh the current benefits against the current costs of beginning this transition now, feel free to reach out to our experts to help analyze your specific situation.


Jonathan Amaya-Hodges, Director, Technical Services, Suttons Creek, Inc. – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.