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 has Proposed a New “Pre-Certification” Regulatory Model for Software-Based Medical Devices

FDA has not finalized or implemented the Pre-Certification Program (Pre-Cert). The agency is still developing this future regulatory model for software-based medical devices. Under FDA’s proposed approach, 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.” FDA’s Pre-Cert Program is intended to support innovation, enable the rapid availability of new and updated software, and focus the agency’s resources on higher-risk products and developers.

The Pre-Cert program is outlined in FDA’s Digital Health Innovation Action Plan,  The Pre-Cert Program entered the “Test Phase” in 2019 with pilot participants that develop software as a medical device (SaMD). In this pilot, FDA is utilizing both 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.

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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