
5 Regulatory Considerations For Developing a Combination Device
A combination product is a product which comprises of two or more items which are covered by different regulations, for example a pharmaceutical and a medical device. As they are covered by two different regulatory structures, then more care needs to be taken when determining the regulatory strategy as it will be more complex.
This blog explains the initial steps of defining a regulatory strategy for a combination product and identifies 5 key regulatory considerations for developing a combination device.
Define your target market(s)
As with any medical device one of the first steps is to understand the business case for the markets you wish to target. There is great benefit in considering regulatory strategy alongside business strategy. You will learn and understand the trade offs between potential market size and costs and timescales to meet regulatory requirements. Once you have selected your market(s), you can consider which regulations apply.
Confirm your product is a combination product
Once you know which market(s) you are working towards targeting, you can review the definitions of medical device, medicinal product and combination devices to determine where your product fits within the categories.
Understand your primary mode of action
Once you have an outline concept of your product and can determine the primary mode of action as described earlier, you can use this to understand which aspects of the regulation of combination products apply and who you need to contact about your product.
Understand your product classification
If the combination is device led, you will need to determine the classification of your device. For the FDA this will require predicate and product code research to understand how similar products have been classified. For the EU, the rules in Annex VIII should be reviewed to determine the classification.
Once the classification is understood it can be used to determine the appropriate regulatory pathway to market.
Make contact with the applicable regulatory body
My last regulatory consideration for developing a combination device is to make contact and confirm your assumptions about the classification of your product once you determine the relevant regulatory body.
For the FDA, this can be done through the Q-sub process1, a request for designation document (RFD)2 or through a 513(g) request3.
With Notified bodies, you can request a “structured dialogue”. Be aware the answers maybe limited as they have to navigate the fact that they are not allowed to provide “consultancy”.
Conclusion
Combination devices are complex as they cover more than one regulatory pathway and require input from more stakeholders on the regulatory journey. The 5 regulatory considerations for developing a combination device in this blog will help build a solid foundation. If you are planning a combination device and seeking development support and regulatory guidance on how best to commercialize your product, then please contact us. Our experienced team will be happy to discuss the best pathway for your project.
Other useful references:
Combination Products | FDA
Combination Products Guidance Documents | FDA
Medical devices | European Medicines Agency (EMA) (europa.eu)
Citations
Helen Simons is the Director of QA/RA at StarFish Medical. Helen’s education is in Mechanical engineering, with a background of product development and QMS development across multiple industries with consumer and industrial products to medical devices, IVD and combination devices.
Image: StarFish Medical