Risk vs. Benefit FDA guidance gets to grips with uncertainty

27 September 2018 |


Doing risk management in an uncertain world is why regulatory affairs are as much art as science. Innovators will continue to push the envelope of the possible while regulators will always be conservative. New draft US FDA guidance attempts to put a more formal framework around dealing with uncertainty and includes the perspective of all players – including the patient.

The natural conservatism of regulators is most evident in the review of high-risk devices. Yet these are the areas where innovators are most likely to bring something radical. And a common charge against regulators is the stifling of innovation. See this article for a close look at how regulator caution delayed the introduction of transcatheter heart valves (now the standard of care) in the US compared to Europe.

So how to balance these competing demands?

A new FDA draft guidance Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions provides a valuable attempt to codify approaches to bring into the open tangible ways to mitigate risk, to weigh patient benefits and to go to the clinic earlier for breakthrough devices.

The guidance, as its long-winded title says, applies to reviews of high-risk device submissions via PMA, HDE or de novo pathways.

It’s a comprehensive effort. As well as considering the obvious – of attempting to quantify and balance risks, benefits and uncertainties, the guidance considers the central questions of patient perspectives, public health need and the feasibility of development of extensive premarket clinical data for potentially high value innovative technologies and crucially the probable benefits of earlier patient access to the device.

The guidance looks at special cases of breakthrough devices and devices subject to PMA which address small patient populations, with worked examples for these cases.

A common refrain of manufacturers is that if there is reasonable assurance of safety, then regulators should allow devices to go to market on condition of post-market clinical follow up. But as the draft points out, manufacturers have to keep their part of the bargain, with timely data collection and fully transparent postmarket reporting. The guidance warns that “FDA also intends to take appropriate administrative or enforcement action if a sponsor does not generate and submit the requisite postmarket data within the specified timeframe”. That’s a whole other balancing act.

Link: FDA draft guidance

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