The Food and Drug Administration has been at the forefront of ensuring medical safety for Americans since 1906, overseeing the development of new technologies and treatments that benefit patients and providers across the country. Since its inception, the FDA has strived to stay on top of emerging technologies in order to ensure that new developments in care are available as quickly as possible. However, with the recent boom in digital health technologies from wearables to software, healthcare regulations have been somewhat slow to adapt. Heavy regulation and a system built largely on legacy products have prevented innovation and prevented the kind of disruption in the healthcare industry that’s emerged in other industries. Of course, regulation is incredibly important to ensure patient safety, but it needs to also allow for efficient access to the best new products.
With that in mind, the FDA just announced a new plan of policy and strategy changes to empower digital healthcare innovators and streamline regulatory processes that will keep up with the pace of today’s development. Most primarily, the FDA will now certify firms and developers, rather than products, so that companies with an established track record of excellence and safety will be able to iterate and market products without unnecessary oversight. Additionally, select creators will be eligible for a streamlined premarket review to ensure that patients can access helpful new technologies as quickly as possible. By placing more trust in developers who demonstrate “a culture of quality and organizational excellence,” the FDA can focus their resources and support innovation for good.
For low-risk technologies, such as wellness products and data display applications, the FDA will loosen regulations overall, allowing patients to make the decisions that they feel are best for themselves as long as there’s little risk of harm from these products. In order to do this, the FDA is flexing the power of new legislation. The 21st Century Cures Act, passed in December 2016, de-classifies this sort of low-risk medical software as a “medical device,” reducing the necessary regulation it’s put under.
Finally, the FDA intends to support future developments by helping firms collect and process real-world data on the impact of their products. The National Evaluation System for Health Technology (NEST), will help firms apply advanced analytics to their devices to gather more information on medical devices that will help regulatory decision-making and device innovation in the future.
Applications for the first cohort of the Software Precertification Pilot Program open on August 1st, and early participants will have the opportunity to provide input on the new process. The FDA will select up to 9 eligible participants for the first cohort, which will begin on September 1st, 2017. To apply, visit the FDA’s website: http://bit.ly/2vg3DJk.