Case study: A smart benefit-risk strategy for market entry via the De Novo pathway

Lessons learned from a smart strategy to demonstrate safety and effectiveness of a novel software device through evidence-based benefit-risk determination.

A vast majority of medical devices are cleared through the 510k pathway because their safety and effectiveness can be demonstrated by making a case of substantial equivalence to a currently marketed predicate device.

What if your device is so novel that there is no suitable predicate? Or the FDA does not agree with your selection of the predicate device in your 510k submission?

This is where the De Novo pathway¹ is an excellent option for your regulatory strategy. It is a risk-based classification process where FDA can grant you market access with regulatory controls similar to Class I and Class II medical devices. Unlike the premarket approval (PMA) pathway required for high risk Class III devices, the De Novo and 510k pathways offer a faster market access.

As noted above, De Novo is a risk-based pathway. Risk practitioners, in collaboration with cross-functional business partners, can play a significant role by contributing to the development of an evidence-based benefit-risk determination to convince the FDA about safety and effectiveness of their device.

In this case study, we share lessons learned from a recently approved² novel software application from Apple, intended to be used with a compatible electronic product to help individuals with mild to moderate hearing impairment. Apple used a fairly novel approach to combine this application with the AirPods Pro, and the current iOS operating system, to limit the scope of FDA’s review to only the hearing aid feature in the software.

Let us dive in.