Regulatory Pathways for Medical Software

Regulatory Pathways for Medical Software: A Discussion with Holland & Knight Experts

February 2, 2021 – By Jared Mueller, Director – Mayo Clinic Innovation Exchange

As part of Holland & Knight LLP’s relationship with the Mayo Clinic Innovation Exchange, H&K partners meet with Innovation Exchange members both one-on-one, and via presentations on topics of interest to healthcare startups. Holland & Knight has one of the largest healthcare and life sciences law practices in the U.S. In a talk earlier this winter, attorneys Michael J. Werner — the co-chair of H&K’s national Healthcare and Life Sciences group — and Sara M. Klock discussed the U.S. Food and Drug Administration’s (FDA) approach to regulating medical software.

Q: How should entrepreneurs and innovators looking at medical software think about their regulatory path to market?

MW: The threshold question for any product is: is this software a medical device at all? If it does not meet the threshold for a medical device, then the FDA does not regulate the product. In that case, there are other federal regulations that the software developers will need to contend with, but from an FDA perspective they will not need to seek device authorization. This could include software that is designed for “general wellness,” as well as software classified as clinical decision software.

On the other end of the spectrum, there are some software products that not only qualify as devices from FDA’s perspective — but that also require pre-market review. Other software products are considered devices, but do not require pre-market review. These tools are subject to what is called “enforcement discretion.” Enforcement discretion means that the FDA retains the authority to regulate a product as a device and impose its requirements, if it so chooses. Each of these regulatory classifications carries its own rights and obligations.

Q: What are a few questions an innovator or team should ask to understand if a software product qualifies as a medical device?

SK: Software applications in healthcare include fitness tracking apps, picture archiving and communication systems (PACS) and medical imaging tools, telehealth and health IT systems, and digital therapeutics — among other categories. Innovators should clearly scope out and state the service that their product aims to provide, given the significant implications the choice of application has for their regulatory pathway.

When it comes to Software as a Medical Device, the higher the risk a piece of software can impose on patients, the more likely FDA will treat the innovation as it would any medical device, with significant regulatory oversight. For certain software products categorized as medical devices, there does exist the more-moderate “enforcement discretion” status. Software tools in that category may be less actively regulated than typical medical devices, but the FDA still reserves the right to apply more-intensive regulation to the software, as needed. Software that helps automate simple tasks for healthcare providers, without providing specific treatment or treatment suggestions for patients, can often fall under the enforcement discretion category.

As Michael said, a third category for software is non-device software. Many applications fall into this category. What is important to understand is: for software, the FDA applies the same risk-based framework to determine if a product is a medical device, and how the FDA ensures the product is safe and effective, as it does for more traditional medical devices.

Q: Beyond meditation applications, fitness trackers, and other sorts of wellness tools, are there other categories of healthcare software that are commonly exempted from device regulation?

SK: The 21st Century Cures Act was signed into law in December 2016. Per the FDA, the Cures Act was “designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.” One element of the Act amended the definition of “medical devices” to exclude certain software functions intended for administrative support in healthcare; general wellness; electronic patient records; clinical decision support; and software that transfers, stores, converts, or displays patient-related information. The parameters delineating medical device and non-device software can be nuanced, so innovators are advised to conduct a thorough regulatory analysis to understand which category is most likely to apply to their product.

Q: What breakthrough innovations in healthcare delivery or technology excite each of you the most?

MW: Continued development of technologies that allow people to better understand and take greater control of their health. I’m looking forward to more products that not only provide more information but do so in a way that’s easy for consumers to use and understand.

SK: I’m really looking forward to seeing the advancement in artificial intelligence in medical devices. The FDA is still determining how the Agency will regulate this technology, so it is exciting to be in the middle of both technological advancement and regulatory advancement.

Views expressed by guests are their own and do not necessarily reflect the views of Mayo Clinic. As a not-for-profit 501(c)(3) charitable organization, Mayo Clinic does not participate in political activities.