The new FDA: navigating the moving line between consumer & medical.

Creating new products used to be easier – it was clear whether it was a consumer product or a medical device. As new categories emerge, the boundary becomes more complex and less clear. For some products focused on health and well-being, it’s now possible to take two separate paths that could impact the business model and commercial position. Fortunately, the FDA has recently developed guidance on how to navigate these two pathways.

The FDA determines if a product is regulated, i.e., that they classify it as a medical device. In this discussion, ‘consumer product’ refers to a product the FDA does not consider a medical device, i.e., is not regulated.

This series of questions can help navigate these two pathway options, and are later explored in greater depth:

1. Does the product have associated risk? Is it diagnosing or treating? If yes, it’s most likely the FDA would consider it a regulated medical device.

2. Is it on the boundary between regulated or not, and is it low risk? If so, there is likely the ability to choose a particular pathway based on the claims made, driving towards being classified as a medical device or not.

3. What is the benefit to choosing the medical device pathway? Consider the pros and cons to understand commercial risk, timing, and cost.

4. If a regulated device is not the desired pathway, what claims can be made without triggering FDA regulation while still marketing the device in the best possible way?

Sorting out the boundaries – is it a medical device?

The boundary is shifting in the definition of what is a medical device. A device used to be defined as a physical thing, but now can be solely software. To synthesize from recent guidance documents, the general boundaries are:

It is a medical device if it is:

  • Diagnosing, making clinical recommendations, analyzing data to make medical conclusions, or
  • Collecting and analyzing raw physiological data: “acquire, process, or analyze a medical image or a signal from an in-vitro diagnostic device or a pattern or signal from a signal acquisition system”

It’s a consumer product (not a medical device) if it is (all of the following):

  • Gathering and presenting information
  • Assessing data against known guidelines and clinical practices (e.g. there are known guidelines which inform what should be done, and this serves only to identify which guidelines are relevant)
  • Designed not to provide the diagnosis, but provide something to be reviewed by a medical practitioner
  • A general wellness product that meets the following two factors: (1) is intended for only general wellness use, and (2) presents a low risk to the safety of users and other persons

What claims can you make?

As the FDA clears/approves a drug or device, it’s also evaluating the set of claims made about the benefit of the product. 

Do you want to seek FDA clearance/approval? Here are some pros and cons.

Seeking FDA clearance / approval pros and cons

After deciding the pathway (regulated / not regulated), there are important considerations and actions appropriate to that chosen pathway. If the choice is to not submit to the FDA, the challenge becomes developing strong claims without crossing the line of it becoming a medical device. The FDA has provided guidance about this:

“A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition."

Here is a weight-related product example the FDA used to clarify general wellness vs. medical claims:

  • General Wellness claims:
    • to promote a healthy weight, encourage healthy eating, or assist with weight loss goals
  • Medical claims
    • that a product will treat or diagnose obesity
    • that a product will treat an eating disorder, such as anorexia

The FDA guidance clarifies how to steer the claims:

“Both subcategories of disease-related general wellness claims should only be based on references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. That is, the claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are described in peer-reviewed scientific publications or official statements made by healthcare professional organizations.”

The guidance then provides several examples of how to word them, such as:

  • Software Product U coaches breathing techniques and relaxation skills, which, as part of a healthy lifestyle, may help living well with migraine headaches.
  • Software Product V tracks and records your sleep, work and exercise routine which, as part of a healthy lifestyle, may help living well with anxiety.
  • Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.
  • Product Z tracks activity sleep patterns and promotes healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes.

The FDA is permitting surprisingly strong claims when worded in the proper way. For example, it may be surprising that a company could make the claim that their product “may help reduce the risk of high blood pressure.” without requiring FDA regulation, as in the above example of “Product X”.

Product development implications

In new product business proposals, we often see a lack of reasonable consideration of whether companies wished to release a regulated device or not, and of the implications of that decision: reimbursement strategy; claims strategy, and how that links to their business case. This choice typically leads to very different pathways to product launch, involving different timelines, hurdles, and risk mitigation approaches. The revenue models are often quite different between medical and consumer as well. For a consumer product, what is the claim strength, and the corresponding market reaction to those claims? Because consumer products typically cannot make the same specific and direct claims afforded to a medical device, the consumer is often left with a soft promise, for which they need to draw their own connection and conclusions. For medical devices, reimbursement codes are necessary for insurance payments, and the market for private pay items is usually substantially smaller. Obtaining codes, state-by-state, or payor by payor basis needs to be considered and is not an activity to be underestimated. Reimbursement strategy is one of the first activities any company developing a regulated device should fully understand, as the outcome can drive both regulatory strategy and product design.

Furthermore, as products on the medical/consumer boundary, such as digital health products become more prevalent, companies often have business plans based on an initial launch as a non-medical device, with a follow-on regulated medical device. This tiered pathway approach helps mitigate the material (6-12 months) delays inherent in the different regulatory processes, as well as the risks. If the FDA determines there is an issue with a submission, that restarts the clock, potentially adding further substantial delays.

As consumer products and medical devices become more software dependent, it is becoming more common for development teams to operate on rapid 2-week development sprints, which is substantially out of sync with the slower FDA regulatory clock. The FDA is taking steps to reduce this gap, however, and has created a key pilot program, the Digital Health Software Pre-Cert Program, because “The FDA recognizes that we need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, its unique user interface and the industry’s compressed commercial cycle of new product introductions.” See an update in “Current progress with the Digital Health Software Pre-Cert Program.

The Pre-Cert program is in an early phase of development and as it’s fully deployed, participating companies can apply for pre-certification; certifying their data and quality systems enables them to substantially simplify their development and FDA submission process. This pre-certification will allow companies to assume some of the regulatory burden; by doing so the FDA will permit them more freedom and control in their release process, with the intention of reducing their product release cycle time.

This paper is extracted from a larger whitepaper which evaluates these issues in depth: The new FDA: navigating the moving line between consumer & medical.

David Ritscher
Connected System Architect
With a focus on connected devices, consumer products, wearables, and implantable medical  devices; design of sensor systems, algorithms, DSP, machine learning; experienced in bringing new concepts from ideation to research and development through successful product launch