In addition to taking steps to clarify the FDA’s position on digital health, we’re also working with our global counterparts to harmonize and streamline the regulation of digital health products internationally.

Innovations in digital health remind us that we live in an interconnected world – one that reaches across borders and joins us in new and unique ways. That’s why in recent years, we’ve worked closely with regulatory authorities across the globe through the International Medical Device Regulators Forumdisclaimer icon (IMDRF) to evaluate requirements in individual countries, and harmonize our regulatory approaches to digital health medical devices, where possible. Many of our global counterparts are represented, including Australia, Brazil, Canada, China, the European Union, Japan, Russia and Singapore.


As part of our package of policies being announced today, the FDA also is issuing a final guidance, “Software as a Medical Device: Clinical Evaluation,” in fulfillment of these international harmonization efforts. This guidance was initially issued in draft in October 2016 and informed by global and domestic comments. Today’s final guidance expands on that draft. It establishes common principles for regulators to use in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD). This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. The agency’s adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight, and is another important piece in our overarching policy framework for digital health.

In sum, these three important guidance documents being issued today will continue to expand our efforts to encourage innovation in the ever-changing field of digital health. Our aim is to provide more clarity on and innovative changes to our risk-based approach to digital health products so that innovators know where they stand relative to the FDA’s regulatory framework. Our interpretation of the Cures Act is creating a bright line to define those areas where we do not require premarket review. And we’re providing more detail on those technologies and applications that would no longer be classified as a medical device subject to FDA regulation. This will allow us to focus our efforts on the highest-risk products. Finally, we’re issuing new details on the common principles we and our international partners will use for evaluating the safety and effectiveness of SaMD. Through this comprehensive approach, we can deliver on our commitment of promoting beneficial innovation in this space while providing proper oversight where it’s merited.

We’ll be taking other steps to implement our Digital Health Innovation Action Plan. We’re hosting a Pre-Cert Pilot Program workshop on January 30-31, 2018 to update FDA staff, participants and stakeholders on the lessons learned from the pilot. Later in the year, we’ll share the pilot’s proof of concept and outline next steps for establishing a Pre-Certification Program. We look forward to working with patients, providers, technology developers and other customers in helping Americans access safe and innovative digital health products.

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