Sometimes major changes in healthcare happen with pomp, circumstance, and pageantry, as when President Obama signed the Patient Protection and Affordable Care Act. Sometimes a significant change to the foundation of healthcare sneaks out into the world as a short blog post on a lazy Thursday afternoon. Such was the case last Wednesday when Food and Drug Administration (FDA) Commissioner Scott Gottlieb wrote on the FDA's blog about potential changes to the way medical devices will be regulated, titled "Fostering Medical Innovation: A Plan for Digital Health Devices." If accomplished, these changes will have an important influence on connected health technologies.
For those not familiar with the system, in the United States, medical devices must be "cleared," or accepted as safe and effective by the FDA before their sale. What is and what isn't a "medical device" is open to much interpretation based on the way governing laws are written, but the formal definition from FDA's website is that a medical device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Many connected health tools can fall under this definition if their manufacturers market them for chronic diseases like diabetes, hypertension, or even obesity. The subtleties of this system can fill pages on its own, but what is important is what Commissioner Gottlieb announced last week and how it differs from the current regulatory scheme.
Under existing regulations, FDA classifies medical devices as one of three classes depending on their potential risk of harm to a user. Class I devices have the lowest injury potential. Examples include tongue depressors, gauze pads, and dental floss. Class III devices have the highest harm potential, or, importantly, are new and therefore have an unknown risk. Implantable defibrillators are an example of a Class III device. Most other devices fall into Class II, including weighing scales, blood pressure monitors, and blood glucose meters. Moving from Class I to Class III, manufacturers must meet more stringent requirements: from a basic quality control system for Class I devices to potentially years of clinical trials for Class III. The concern of the market regarding new connected health devices based on software and networked components stems from the fact that their unknown risk makes them a Class III medical device unless otherwise exempted. In 2014, FDA helped reduce some of this burden when it released guidance for Medical Device Data Systems (MDDS). The MDDS guidance highlighted several categories of products that FDA would consider Class I devices by default. In 2015, FDA again issued guidance for Mobile Medical Applications, which helped define some areas where FDA would exercise "enforcement discretion" for particular types of mobile apps. Both of these were important steps in making the FDA regulatory scheme easier to navigate and more consistent with modern software and network-driven connected health devices. However, the industry has continued to seek guidance and clarity on how new generations of networked devices will fit into FDA's thinking. On Wednesday, the beginning of an answer appeared in Dr. Gottlieb's blog post.
There are three initiatives outlined in the post:
- An "entirely new approach to the regulation of digital health tools," and "…a more efficient, risk-based regulatory framework."
- A (potential) third-party certification program allowing companies to market low-risk products without direct FDA review.
- Post-market collection of real-world data as evidence for new product functions.
If implemented, these three initiatives would mark a seismic shift in how FDA looks at innovative digital and connected health systems. The change in thinking might herald FDA's coming to grips with the increasing role of software and networked components to create new systems-based tools rather than traditional single-purpose devices. Whatever form these ideas take, Wednesday's blog post was a significant event. There will surely be many opportunities for public comment as FDA changes its regulations and systems. What would you like to see changed about how connected health is regulated by FDA?