Digital Health

Digital Health is Driving New Regulatory Models

Digital health technologies are rapidly changing how health care is delivered, and are helping individuals take control of their health. Many digital technologies have intended uses that fall under the scope of FDA’s jurisdiction, but the agency’s regulatory system historically has not been designed to review, clear, approve, or otherwise respond to these products at the rate at which they develop and change. FDA is in the process of developing alternative regulatory models for digital health technologies, and many of these products are currently subject to enforcement discretion. But, digital health technologies must meet certain criteria; otherwise, they could be regulated under the existing device paradigm.

Which Digital Health Technologies are Regulated by FDA?

Digital health technologies include personalized medicine, telehealth and telemedicine, wearable devices, health information technology (IT), and mobile apps. FDA recognizes that digital health can improve the accuracy and efficiency of patient care.

Prior to 2016, FDA issued guidance documents related to mobile apps, and defined many types of software products as medical devices. The 21st Century Cures Act, enacted in December 2016, excluded five categories of software and digital health technologies from being considered devices by amending the definition of “medical device” under the Federal Food Drug and Cosmetic Act (FDCA). To comply with the Cures Act, FDA revised its existing guidance documents and issued additional guidance documents about changes to existing medical software policies under the Cures Act; general wellness products; mobile medical apps; medical device data systems, medical image storage devices, and medical image communication devices; off-the-shelf-software; and clinical decision support software.

FDA Needs New Legislative Authority to Proceed with its “Pre-Certification” Regulatory Model for Software-Based Medical Devices

In 2017, FDA launched a pilot Pre-Certification Program (Pre-Cert) as a proposed regulatory model for Software as a Medical Device (SaMD). The Pre-Cert program, outlined in FDA’s Digital Health Innovation Action Plan, entered a “Test Phase” in 2019 with nine pilot participants.  The pilot explored whether a company – not the software/digital health products it develops – could be “Pre-Certified” if it demonstrates a “robust culture of quality and organizational excellence” and is “committed to monitoring the real-world performance of their products once they reach the U.S. market.”

The agency utilized its traditional regulatory review process and its proposed “Pre-Cert Pathway” to determine if premarket regulatory decisions can be made under the Pre-Cert model. Specifically, FDA examined whether data about a manufacturer’s culture and quality programs, the total product life cycle (TPLC), and real-world evidence could be applied to assess a product’s safety and effectiveness. FDA hoped that such data could be leveraged so that new software products (or changes to software products) would not need to undergo premarket review, so long as the manufacturer was precertified.

On September 26, 2022, FDA released its final report on the SaMD Pre-Cert pilot. The report concludes that the pilot’s innovative approach to regulatory oversight of SaMD could be relevant to medical device software generally and could support a future regulatory program. But, FDA acknowledged that it cannot implement such a program without new legislation from Congress.

During the pilot, FDA identified Key Performance Indicators (KPIs) that can “provide insight into an organization’s software development, monitoring, and maintenance processes, and the impact those processes have on the safety and effectiveness of medical device software. Common KPIs, which FDA believes can help assess safety and effectiveness, include data quality, defects, complaints, device activation/user adherence, regression testing, releases, rollbacks, services, and security. 

Applying the metrics used in the Pre-Cert pilot to SaMD reviews would create a new regulatory paradigm that exceeds FDA’s authority under the FDCA. The agency acknowledges in its final report that it cannot implement the precertification program without legislative change. The report itself lays out the authority FDA needs from Congress, including to be able to apply KPIs and real-world performance metrics to enable more timely and targeted regulatory review and action. It is important for developers and manufacturers of all medical software to watch whether new legislation is proposed and how broad its application will be. 

Penn Avenue Law & Policy Can Chart a Regulatory Course for Digital Health Technologies

Penn Avenue Law & Policy can advise you regarding the current regulatory status of your software and digital health technologies. The firm can help determine potential future pathways for your products, based on FDA’s proposals and your business goals. Christine P. Bump has represented companies of all sizes in the digital technology space and has the experience and ability to steer rapidly changing technologies through evolving regulatory landscapes.

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