More Digital Health Device Makers Expected to Seek FDA Clearance

Investors are increasingly interested in companies with technologies that will be subject to U.S. Food and Drug Administration (FDA) regulation.

Until recently, some investors shied away from companies targeting the regulated space out of concern that the regulatory landscape created too much risk. However, thanks in part to new guidance from the FDA regarding the treatment of digital health apps, the tide is turning and many investors feel the opportunities outweigh the downsides of longer product cycles and negotiating payment through third parties. As MobiHealthNews reports, greater clarity from the FDA will be welcomed in many parts of the industry. We believe the number of cleared devices will increase next year as a result of three guidances issued by the FDA this summer.

General Wellness
The most significant was the final guidance for low-risk general wellness devices. This guidance clarifies when wellness devices and apps cross over into the regulated sphere.

Devices and apps making general wellness or fitness claims, and those that do not make “any reference to diseases or conditions,” should not be subject to agency oversight. These claims include assertions related to weight management, fitness, relaxation or stress management, mental acuity, self-esteem, sleep management or sexual function.

However, claims that a product will treat or diagnose diseases such as obesity, an eating disorder, an anxiety disorder, autism or muscle atrophy, or a claim that a device or app will restore a structure or function impaired due to a disease or a condition, may require FDA clearance.

The FDA noted that the category of low risk general wellness devices also includes products that 1) “promote track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and 2) … promote track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain diseases or conditions.” (Emphasis is the FDA’s.)

The guidance also provides some tests to determine if and when a product is not low risk and thus subject to clearance. Those tests include:

  1. Is the product invasive?
  2. Is the product implanted?
  3. Does the product involve a technology that may pose a risk to the safety of users and other persons?

Submitting a 510(k) for a Software Change to an Existing Device
Over the summer, the agency also provided draft guidance on when a software change to an existing device requires a new 510(k) clearance. As app developers typically issue regular software and firmware updates, this guidance will be important in helping digital health tool developers to know when an update will trigger a new clearance.

Using Data From Real-World Sources
Finally, the agency issued draft guidance on the use of real-world evidence to support regulatory decision-making for medical devices. This guidance covers when companies can use “real-world” data as evidence for FDA regulators who are making decisions regarding the company’s medical devices.


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