Best regulatory path | Sagentia Innovation

Determining the best regulatory path for your medical device

What’s the best route to market for your medical device? Read our insights on how to balance regulatory and commercial requirements.

When it comes to regulatory matters, manufacturers of medical devices often hold conflicting objectives. On the one hand, they want to market their product as being novel or unique. At the same time, they need to market their devices as soon as possible to generate revenue and capture market share. The 510(k) premarket notification path is generally the quickest and least expensive route for obtaining FDA’s authorisation to market a device. However, the 510(k) route is only for devices that are substantially equivalent to legally marketed devices. Accordingly, 510(k) devices cannot claim to be novel or unique. FDA reviews novel devices through the De Novo review route, if they are low to moderate risk, or the Premarket Approval (PMA) route, if they are high risk. Thus, it often takes longer to obtain premarket authorisation for a novel/unique device.

So, what are the pros and cons of PMA versus 510(k)? What are the alternatives such as De Novo down classification? And how can manufacturers of medical devices exert more influence over their regulatory destiny?

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