Statement from FDA Commissioner Scott Gottlieb, M.D.

, on advancing new digital health policies to

encourage innovation, bring efficiency and modernization to regulation

For Immediate Release

December 7, 2017

Today were announcing three new, significant policy documents to advance the FDAs approach to the
development and proper oversight of innovative digital health tools. We know that consumers and
health care providers are increasingly embracing digital health technologies to inform everyday
decisions. From fitness trackers to mobile applications tracking insulin administration, these digital tools
can provide consumers with a wealth of valuable health information. Further, clinical evidence
demonstrates that consumers who are better informed about health make better and more efficient
decisions, take steps to improve their lifestyles and their health choices, and often experience better
outcomes.

Given these meaningful benefits from empowering consumers, we believe the FDA must, whenever
possible, encourage the development of tools that can help people be more informed about their
health. And we recognize that our regulations play a crucial role in the efficient development of such
technologies. Therefore, our approach to regulating these novel, swiftly evolving products must foster,
not inhibit, innovation. Moreover, we must always lean in the direction of enhancing access to more
information not restricting information flow given the ability of reliable information to positively
impact daily life.

Over the last five years, the FDA has made great strides in adapting our policies to better align our
regulatory approach to the iterative nature of digital health products. Were finding that in some parts
of our regulatory portfolio, our traditional approach to overseeing certain health care products does not
easily fit the types of innovations that are being developed. In these cases, we must adapt and evolve
our policies to make sure we continue to provide a gold standard for oversight, while enabling
advancement of beneficial innovations and greater consumer access to technologies that can improve
their health.

To this aim, this past summer, we issued the Digital Health Innovation Action Plan, which outlines our
efforts to reimagine the FDAs approach to ensuring all Americans have timely access to high-quality,
safe and effective digital health products. As part of this plan, we committed to several key goals,
including increasing the number and expertise of digital health staff at the FDA, launching the digital
health software precertification pilot program (Pre-Cert) and issuing guidance to modernize our
policies.

As we come to the end of 2017, Im proud of the significant progress the FDAs digital health team has
made on the Action Plan. We launched the Pre-Cert pilot and selected nine diverse companies to
participate. We also have invested in hiring additional talent for our digital health team, including
announcing the Entrepreneurs in Residence program. Yet, we recognize theres more work to do.
Today, were announcing three new guidances two draft and one final that address, in part,
important provisions of the 21st Century Cures Act (Cures Act), that offer additional clarity about
where the FDA sees its role in digital health, and importantly, where we dont see a need for FDA
involvement. Weve taken the instructions Congress gave us under the Cures Act and are building on
these provisions to make sure that were adopting the full spirit of the goals we were entrusted with by
Congress.

The first draft guidance, Clinical and Patient Decision Support Software, outlines our approach to
clinical decision support software (CDS). CDS has many uses, including helping providers, and ultimately
patients, identify the most appropriate treatment plan for their disease or condition. For example, such
software can include programs that compare patient-specific signs, symptoms or results with available
clinical guidelines to recommend diagnostic tests, investigations or therapy. This type of technology has
the potential to enable providers and patients to fully leverage digital tools to improve decision making.
We want to encourage developers to create, adapt and expand the functionalities of their software to
aid providers in diagnosing and treating old and new medical maladies.

This draft guidance is intended to make clear what types of CDS would no longer be defined as a medical
device, and thus would not be regulated by the agency. For example, generally, CDS that allows for the
provider to independently review the basis for the recommendations are excluded from the FDAs
regulation. This type of CDS can include software that suggests a provider order liver function tests
before starting statin medication, consistent with clinical guidelines and approved drug labeling.

However, the FDA will continue to enforce oversight of software programs that are intended to process
or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor
like an electrocardiogram that use analytical functionalities to make treatment recommendations, as
these remain medical devices under the Cures Act. For example, we would continue to oversee
software that analyzes data from a patients spinal fluid test to diagnose tuberculosis meningitis or viral
meningitis. These are areas in which the information provided in the clinical decision software, if not
accurate, has the potential for significant patient harm, and the FDA plays an important role in ensuring
the safety and effectiveness of these products.

Similarly, the CDS draft guidance also proposes to not enforce regulatory requirements for lower-risk
decision support software thats intended to be used by patients or caregivers -- known as patient
decision support software (PDS) -- when such software allows a patient or a caregiver to independently
review the basis of the treatment recommendation. Although PDS was not part of the Cures Act, the
FDA believes that PDS should follow a similar regulatory structure as CDS. An example of lower-risk PDS
products could include software that reminds a patient how or when to take a prescribed drug,
consistent with the drugs labeling. PDS software that does not clearly allow independent review of the
recommendation by the patient or a caregiver would continue to be subject to the FDAs active
oversight. This might include a warfarin monitoring device that makes recommendations for dosing
based on the outcome of a home blood test.

We believe our proposals for regulating CDS and PDS not only fulfill the provisions of the Cures Act, but
also strike the right balance between ensuring patient safety and promoting innovation.

The second draft guidance being issued today, Changes to Existing Medical Software Policies Resulting
from Section 3060 of the 21st Century Cures Act, addresses other digital health provisions included in
the Cures Act. Specifically, this second guidance outlines the FDAs interpretation of the types of
software that are no longer considered medical devices. Were making clear that certain digital health
technologies such as mobile apps that are intended only for maintaining or encouraging a healthy
lifestyle generally fall outside the scope of the FDAs regulation. Such technologies tend to pose a low
risk to patients, but can provide great value to consumers and the healthcare system.

Through this draft guidance, were proposing changes to previously published agency guidance
documents, including: General Wellness and Mobile Medical Applications, among others, to be
consistent with the Cures Act and reflective of the agencys new, more modern approach to digital
health products. The proposed changes include updating the categories of products for which, prior to
the Cures Act, the FDA already intended to exercise enforcement discretion owing to their very low risk
and potential benefits to patients from greater innovation. Now, to create an even clearer distinction,
consistent with the Cures Act, were saying that many of these products no longer qualify as medical
devices that would be subject to the FDAs oversight.

In addition to taking steps to clarify the FDAs position on digital health, were 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. Thats why in recent years, weve worked closely with
regulatory authorities across the globe through the International Medical Device Regulators Forum
(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. Todays 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 agencys 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 FDAs 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
were 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, were 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 its merited.

Well be taking other steps to implement our Digital Health Innovation Action Plan. Were 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, well share the pilots 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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Posted December 7, 2017

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587890.htm