FDA and Industry Move on mHealth Guidance

Sep 14, 2017

With the growth and increasing applications of mHealth comes the need to regulate, and the biopharmaceutical industry and regulatory bodies, such as the FDA are coming together to develop frameworks for mHealth utilization in clinical trials. Austin Speier, VP of Emerging Technologies at Precision for Medicine, recently spoke about mHealth regulatory pathways at PanAgora’s Mobile Innovations Summit, and will elaborate further in this interview.  PanAgora’s Clinical Trials & IoT Forum is occurring at Pfizer’s Innovation Research Lab November 8-9, 2017 in Cambridge, MA.

Moe Alsumidaie: Can you describe FDA’s Digital Health Unit? What can they do, and what can’t they do?

Austin Speier: The latest Medical Device User Fee Amendments (MDUFA IV), which is largely responsible forfunding FDA’s activities, included establishment of aspecialized Digital Health Unit within FDA’s Center for Devices and Radiological Health (CDRH). The new group will act as a central technical resource for the Device Center. The vision is to hire scientists with specific experience in key aspects of digital health—such as machine learning, artificial intelligence, cybersecurity, interoperability, and systems integration—to provide centralized, consistent expertise whenever a digital product is with FDA’s device center for pre-market review. Right now, that review is done individually by each of the Center’s clinically-focused Branches, so a developer’s experience with Digital Health can vary greatly across, for example, the respiratory and the dermatology Branches. The Digital Health Unit will act as a centralized resource that will lead to greater consistency across Branches. However, the unit will not take on direct pre-market review authority itself; that will remain with the clinically-focused Branches in the Office of Device Evaluation (ODE).

The other responsibility of the Digital Health Unit will be to guide regulatory policy for digital health products.  This will be done by publication of Guidance documents, working with international regulators on a harmonized approach to digital health, and by establishing review pathways specific to Software as Medical Device (SaMD) and Software in Medical Devices (SiMD). The Digital Health Unit is very pro-innovation, with many thanks to Bakul Patel’s leadership, so I expect they will work hard to find the right balance between building a new, flexible regulatory paradigm for digital health—one that can better match the rapid rate of innovation the tech world—while still meeting FDA’s obligation to promote and protect the public health. The Digital Health Innovation Plan is a good example of that.

MA: What is the purpose of FDA’s Digital Health Innovation Plan?

AS: The Digital Health Innovation Plan was announced by the new FDA Commissioner, Dr. Scott Gottlieb earlier this summer. It is a concerted effort to update FDA’s regulatory policy and pathways to better meet the needs of digital health innovation. For now, it primarily consists of FDA committing to issue several clarifying Guidance documents, and the new Pilot Pre-Certification (Pre-Cert) program.

MA: Do you expect the FDA to release a guidance document for mHealth in clinical trials first, or in post marketing applications?

AS: The Guidance document most directly relevant to mHealth in clinical trials will be FDA’s adoption of the IMDRF final framework for the clinical evaluation of SaMD. This will be especially relevant for mHealth tools that make a clinical claim, by contributing to either the patient’s treatment or diagnosis or monitoring, and therefore are considered medical devices by FDA. mHealth tools used for research in drug trials will continue to be regulated primarily by FDA’s drug center, the Center for Drug Evaluation and Research (CDER). We expect the SaMD clinical evaluation guidance to be released towards the end of this year. IMDRF is expecting to finalize its framework in September, then FDA may need some time to determine how to adopt the final framework, for example in part or in full.

Other key guidance documents will be on Clinical Decision Support Software and on digital health products containing both regulated and unregulated features. These documents will help a mHealth developer or a study sponsor determine whether the mHealth tools in their study might be regulated by FDA once on the market, or if they may be subject to investigational device requirements. FDA plans to release draft versions of those Guidance documents for public comment in the first quarter of 2018.

MA: Do you expect to see any FDA-issued guidance documents for implementing mHealth in clinical trials soon? What would an FDA-issued guidance document look like for mHealth in clinical trials?

AS: For now, the new Digital Health Unit is focused on Software as Medical Device and so their efforts areprimarily within CDRH, FDA’s device center. A cross-center Guidance co-authored by CDER, FDA’s drug center, would be required to fully address the use of mHealth in clinical trials. There are no announced plans for such guidance now, however that may change in the near future. We saw this happen with the advent of companion diagnostics over in the In Vitro Diagnostics group within CDRH. They now cooperate closely with CDER on regulatory pathways and reviews for companion diagnostics. Given this precedent, we may expect to see Guidance on mHealth in clinical trials come out in a specialized area such as oncology first, where FDA has established an Oncology Center of Excellence that is designed to integrate across all of FDA’s various divisions.

Ultimately, however, the emphasis will be on the intended use of the mHealth tool. Once the intended use of the product is clearly defined, you can determine the product’s regulatory status and then engage either FDA’s device center or drug center as appropriate and if needed. As such, we could expect an FDA Guidance on mHealth in clinical trials to lay out product type definitions and a decision tree for consistently determining your product’s regulatory status. In that case, research-only tools would likely remain unregulated, similar to Research Use Only In Vitro Diagnostics (RUO IVDs), while products making marketing claims for a therapeutic or diagnostic-like intended use, or that closely integrates with a regulated drug or device (similar to a companion diagnostic assay), would need to engage with FDA.

MA: What is the industry doing to push guidance for mHealth in clinical trials?

AS: On the clinical research side, the Coalition against Major Diseases, part of the Critical Path Institute, has been working actively with FDA’s drug center to explore the use of mHealth tools in drug studies in several workshops and working groups. On the device side, AdvaMed recently launched AdvaMed Digital to represent developers of SaMD and SiMD, for products that might meet the definition of a medical device. In addition, FDA will host several its own workshops open to the public, and FDA’s planned draft guidance documents will be open for public comment for 90 days once issued. Each of these will be important avenues to engage FDA on the topic of mHealth, and to advocate for a regulatory approach that is responsible while still embracing innovation and the potential of digital health tools for improving clinical care.

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