As part of the Action Plan, we also are exploring what further actions we can take to spur innovation towards technologies that can make devices and their use safer. For instance, our Breakthrough Device Program that helps address unmet medical needs can be used to facilitate patient access to innovative new devices that have important improvements to patient safety. We’re considering developing a similar program to support the development of safer devices that do not otherwise meet the Breakthrough Program criteria, but are clearly intended to be safer than currently available technologies.

In the coming months, we’ll also look at how we can focus more of our regulatory science activities on safety innovation, with the aim towards developing scientific toolkits to be used premarket, so that developers can better assure that their devices are meeting our standards for safety. To help support developers who are pursuing safer devices, we’re exploring ways to permit more streamlined pathways for comparative safety claims as a way to spur competition on improving features related to a device’s safety profile. Along these lines, we issued a new draft guidance last week on a voluntary, more modern 510(k) pathway for moderate risk devices to more efficiently demonstrate safety and effectiveness and the opportunity for device makers to demonstrate their products are safer than other technologies on the market.


Another important element of the Action Plan recognizes that safety and innovation should go hand in hand. The best technological advances should lead to more lives saved and fewer adverse events. We want to take new steps to encourage manufacturers to make even modest iterative changes to their devices, if these new advances and adaptations will lead to a reduction in risk to patients.

These new steps will be all the more effective because of the extensive work we’ve done over the past years to modernize our data gathering infrastructure around device safety – such as our Unique Device Identification System (UDI) and use of real world evidence (RWE). To continue to advance our data gathering, we are continuing our work to establish the National Evaluation System for health Technology (NEST), an active surveillance and evaluation system we have been championing through a public-private partnership.

NEST complements the passive surveillance approaches currently in use. It will facilitate timely detection of potential safety risks that wouldn’t otherwise be identified as quickly, or at all. The Action Plan lays out how the FDA will continue to support the successful development of NEST. As part of our fiscal year 2019 budget, we’re seeking additional funding to advance this program into a more active surveillance tool.

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