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FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D., on agency efforts to work with tech industry to spur innovation in digital health

For Immediate Release:
Statement From:

Owing to digital advances, we’re experiencing a reimagination of health care delivery. Consumers are now empowered to take more control of their own health information to make better informed decisions about their medical care and healthy living. These advances enable better health outcomes for patients.

This opportunity is supported by a new technological paradigm of digital health tools, like apps, that enable consumers to have more active engagement and access to real-time information about their health and activities. These tools allow consumers and providers to supersede the traditional, physical constraints of health care delivery and make the most of the opportunities offered by mobile technology.

With these advances has come a new swath of companies that are investing in these new opportunities. These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.

Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life, such as ride-sharing apps and virtual home assistants. One factor that’s been cited, among many, is the regulation that accompanies medical products.

But momentum toward a universal digital future in health care is advancing. Due to the great promise of these technologies and the rapid pace of change, the FDA is working to modernize our regulatory approach to better enable and more efficiently spur innovation in this novel area to improve the health and quality of life of consumers and patients.

In the last few years, the FDA has been taking steps to encourage more development and greater innovation in the digital health space. With the launch of our Digital Health Innovation Action Plan last summer, we committed to implementing policies, adding expertise, and exploring a software precertification pilot program to bring clarity and efficiency to how we regulate digital health products.

In establishing our regulatory approach to emerging technologies, such as digital health, we have recognized that we must – first and foremost – maintain our scientific gold standard for assuring product safety and effectiveness. We must always put protecting patients at the forefront of what we do.

We also believe that our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation. This requires us to take modern, flexible, risk-based approaches to regulation in this area, which we hope will reduce the time and cost of market entry, while assuring appropriate patient safeguards are in place. We believe this will this help encourage more developers—including those who are new to the health care space—to translate digital advances into tools that benefit patients.

We know that with a more modern, flexible and risk-based approach to regulation, we will see an increase in the development of health products from a variety of digital software developers. Based on the substantial number of applicants to our software precertification pilot program, including traditional medical device companies, large tech companies and small start-ups, we understand more developers are interested in investing and creating products that can impact health care.

As a public health agency, we’re encouraged to see interest from developers in entering the digital health marketplace. And we want developers to know that the FDA stands ready to work with you to bring your safe, effective and innovative products to market. Our message today is clear—we want software developers to create new, innovative technologies that can help consumers take control of their health. As regulators, we will put patient safety at the forefront of what we do. And we will continue to work with developers to ensure their safe, effective and innovative products can enter the market.

The FDA has a long-standing policy of working with medical product companies as they design, develop and test their products prior to formally submitting an FDA marketing application. This is part of our continuing work to create a more modern, flexible and risk-based approach to regulating medical devices.

This commitment is not only reflected in actions like approving or clearing new apps and launching our Digital Health Innovation Action Plan, but also in what we hope to do in the future. That’s why in the FDA’s Fiscal Year 2019 Budget, we proposed to create a Center of Excellence for Digital Health that would advance modernizing our regulatory approach to help this industry grow and reach its full potential, while protecting patients.

This Center of Excellence would help establish more efficient regulatory paradigms, consider building new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices. Our Digital Health Innovation Action Plan demonstrates our commitment to spurring digital health innovation and safety. With the creation of a Center of Excellence, the FDA could commit additional resources to helping developers create innovative products that can benefit patients.

We’re enthused by what we see currently happening in digital health. Recent product approvals and clearances have given consumers and providers access to powerful technologies that have the potential to advance the delivery of health care. We’re also looking forward to the future. We know that our actions  will help encourage the development of incredibly innovative products. We hope to see health care adopting more and more disruptive technologies that positively impact people’s lives.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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