FDA Clarifies Enforcement Position Regarding Evolving Health Technology

By Sheva Sanders, Ryan McGary and Jason Engelhart

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these documents, the FDA sought to identify low-risk “general wellness” products for which FDA does not intend to enforce compliance with FDA regulatory requirements, even if such products are medical devices. In another of these documents, the FDA clarifies for which devices it will not enforce compliance with regulatory controls by virtue of their status as medical device data systems, medical image storage devices, or medical image communications devices. These recent statements from the FDA, coupled with further clarification on a recent FDA-hosted webinar, underscore the following key themes:

  • The FDA is trying to be nimble in its regulatory response to new, evidently low-risk products in the marketplace and in doing so has demonstrated willingness to decline to enforce regulation over products that clearly or potentially fall within the statutory definition of the term “medical device.”
  • These statements help to establish “guard rails” for businesses engaged in the manufacture or distribution of wellness products as well as products that store, transmit or display medical device data. In particular, these statements are helpful in assessing whether the product itself, the company’s marketing of the product, the product’s labeling, or other factors give rise to a concern that the “intended use” of the product is one that would subject the product to active regulation as a medical device.
  • That being said, it is important not to overstate the significance of statements such as these. The exceptions set forth in the draft guidance and guidance discussed in this article are narrow and, in some instances, only underscore the FDA’s long-established, substantial discretion in determining which products it chooses to actively regulate. Furthermore, while the trend seems to be an easing of FDA regulatory activity in this space, the fact that these statements are being proposed and issued as guidance—and not notice and comment rulemaking—also means that the FDA could shift course, modify or expand its guidance in the event it underestimated the risks presented by these products.
  • Even in circumstances in which the FDA has indicated that it does not intend to enforce regulatory requirements that might otherwise apply to a product, the product is not necessarily exempt from all potential enforcement. That is, the product may be subject to regulation by agencies such as the Federal Trade Commission or Consumer Product Safety Commission. 

As we discuss further in the full article, the FDA’s most recent statements regarding low-risk products provide some valuable insight into FDA’s enforcement priorities. These insights are most likely to be relevant to the following types of companies:

  • medical device manufacturers and distributors;
  • companies involved in the development and distribution of “wellness products”; and
  • health IT software and hardware companies.
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