FDA Commissioner Scott Gottlieb trumpeted the agency’s “modern and flexible” approach to digital health regulation when speaking at Health Datapalooza last week.  As we have written about here, FDA has announced multiple initiatives over the last several months designed to clarify the regulatory considerations around new and emerging digital health technologies.  Last week’s speech

FDA announced last week that it is permitting marketing of an mHealth app that uses artificial intelligence (AI) to analyze CT images for signs of stroke. The app, called Contact, is a clinical decision support tool marketed by Viz.AI.  It relies on triage software to scan for potential blockages and then notifies a medical specialist

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities, as one way that the agency seeks to further its public health mission and foster innovation that benefits consumers and patients.  Consistent with this focus, the agency also announced a public workshop on January 30-31, 2018, to discuss the status of its Software Pre-Cert Program, which we wrote about here.

These announcements follow a consistent drumbeat of digital health focus from FDA during 2017, including release of two draft and one final guidance documents that are intended to implement the objectives of the 21st Century Cures Act.  These include the following:

  • The Clinical and Patient Decision Support Software (CDS) Draft Guidance. As explained by FDA, this 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 FDA’s regulation… 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.” The comment period is open until Tuesday, February 6, 2018.
  • The Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Draft Guidance.  This draft guidance updates the agency’s thinking relative to exercise of jurisdiction or enforcement discretion over low risk mobile and digital health products, as previously addressed in FDA’s Mobile Medical Application and General Wellness guidance. The deadline for public comments is Tuesday, February 6, 2018.
  • The Software As A Medical Device (SaMD): Clinical Evaluation Final Guidance. This finalizes draft guidance issued in 2016 and attempts to further global regulatory harmonization efforts by establishing common principles for regulators to use in evaluating the safety, effectiveness and performance of SaMD.


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The “Internet of Medical Things Resiliency Partnership Act of 2017” was introduced in the House of Representative earlier this month.  Co-sponsored by Rep. David Trott (R-MI) and Rep. Susan Brooks (R-IN), the bill would require establishment of “a working group of public and private entities to develop recommendations for voluntary frameworks and guidelines to increase the security and resilience of networked medical devices sold in the United States that store, receive, access, or transmit information to an external recipient or system for which unauthorized access, modification, misuse, or denial of use may result in patient harm.”

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In his keynote address at the AdvaMed annual conference in late September, FDA Commissioner Scott Gottlieb returned to the themes of promoting innovation by partnering with industry.  Consistent with that, and furthering the agency’s emphasis on digital health innovation, he announced the companies that will be participating in FDA’s Pre-Cert program, a program that the agency describes as “intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product.”

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