FDA Goes All Out With Digital Health Regulatory Paradigm Shift

Regulatory NewsRegulatory News | 26 April 2018 |  By 

Digital health is taking the stage at the US Food and Drug Administration (FDA).
From the launch of a premarket digital safety program and an internal data science incubator, to the release of drafted policies for multi-function device products and a working model for FDA’s digital health Pre-Certification program, Commissioner Scott Gottlieb left audience members in a daze with a plethora of announcements at the Health Datapalooza conference Thursday.
Harnessing the potential of digital health tools can lead to “making medical care truly patient-centric” and to reduce healthcare costs and risks to patients, Gottlieb argued.
FDA’s Internal Digital Health Incubator
In support of the agency’s vision to advance digital health innovation, a new internal data science incubator—the Information Exchange and Data Transformation (INFORMED)—for data analytics integration into FDA regulatory decision-making is being created, Gottlieb announced. 
“The initial focus of this new tech incubator will be, among other things, the conduct of regulatory science research in areas related to health technology and advanced analytics related to cancer,” Gottlieb said. “Our goal will be to help modernize our framework for advancing promising digital health tools.”
INFORMED will serve as a tool for the development of new clinical endpoints and evidence derived from artificial intelligence (AI)/machine learning (ML) as FDA expects to see a spike in the number of AI-based submissions in upcoming years, especially for medical imaging devices.
Digital Health Pre-Cert Program
Reiterating the ambitious goal that Bakul Patel, digital health director at FDA’s Center for Devices and Radiological Health (CDRH), has previously relayed, Gottlieb noted the agency is committed to launching “Pre-Cert 1.0” by year’s end.
Agency staff are still working in collaboration with the nine companies—Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily—that were announced last December on designing the Pre-Cert program—intended to foster innovation.
The work involves learning about the participating companies’ approaches to digital health product development to establish a standard of excellence with scalability and flexibility for different types of developers. The firms agreed to FDA site visits for further refinement of the Pre-Cert appraisal model and review process, based on real-world performance data (RWPD).
The first “high-level draft of what will be several iterations” of the Pre-Cert program is now public, Gottlieb announced, noting that new review pathway will be centered on developing a risk-based framework for digital health products by leveraging the approach developed in recent years through the International Medical Device Regulatory Forum (IMDRF).
The 17-page working document provides details on the program's current scope, goal and anticipated benefits, among other elements. It also poses questions for public input by 31 May 2018.
Within digital health, Gottlieb believes AI, in particular, “holds enormous promise for the future of medicine.” By applying the Pre-Cert approach to AI, a firm could provide the added flexibility “to make certain minor changes to its devices without having to make submissions each time.”
Gottlieb pointed to the AI-based Viz.AI Contact application, designed to analyze computed tomography (CT) results for early detection of potential stroke, as an example of a tool that offers “real opportunities to improve medical outcomes, enhance efficiency, and reduce costs.”
Applied AI healthcare company Viz.ai received FDA marketing authorization for the application in February. CEO and Co-founder Chris Mansi told Focus the company intends to participate in the digital health Pre-Cert program once it becomes fully operational.
These changes and the new guidance on device products containing multiple functions form part of FDA’s push—set in motion in 2017 with the Digital Health Innovation Action Plan, prompted by provisions in the 21st Century Cures Act of 2016—for a more modern regulatory approach on digital health tools to keep pace with their iterative nature. They also will allow FDA to reap the benefits from the rapidly changing world of digital health, Gottlieb said.
Multi-Function Products: Draft Guidance
The drafted policies and considerations for industry and agency staff provide initial clarifications on which device products containing multiple functions fall outside FDA’s regulatory scope.
“This guidance clarifies when and how FDA intends to assess the impact of other functions that are not the subject of a premarket review on the safety and effectiveness of a device function subject to FDA review,” the guidance states.
Last December, FDA also issued three separate guidance documents on the types of software for which the agency does not intend to enforce premarket reviews. These efforts are in line with provisions in the Cures Act aimed at incentivizing innovations in the US digital health space.
Programs for Digital Premarket Safety, Application to Drugs
In addition, integration of digital health tools into the drug review and development will be expanded with the launch of a new program.
“Mobile devices and software linked to specific drugs can help patients stay on therapy for treatments where medication compliance is traditionally a challenge,” Gottlieb said at the conference, adding a policy framework will be advanced in this area via new guidance. FDA will be “building off the approach” employed at CDRH to “clarify that not all FDA requirements apply every time a digital health tool is employed in relation to a prescription drug.”
Yet another program to be launched—the Premarket Digital Safety Program—is intended to address challenges with ensuring patient safety in clinical trials for new drugs and biologics. It will be designed around electronic reporting requirements under the expedited safety-reporting regulations of an Investigational New Drug application, according to Gottlieb.
FDA has seen “inefficiencies resulting from a disjointed, analog workflow” among sponsors of clinical trials, Gottlieb said. “Sponsors are submitting premarket safety reports to the FDA on PDF files or on paper via fax or hand-delivered mail.”
This new program will initially involve FDA’s Oncology Center of Excellence, Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).


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