Breathe In, Breathe Out: FDA Tells a Medical Device Company It Needs Its OK to Say That First

Footnotes for this article are available at the end of this page.

In 1994, the rock band Bush sang, “breathe in, breathe out,” in one of its biggest hits, “Machinehead.” In 2023, a medical device company tried to promote its 510(k)-cleared treatment hood/hyperbaric chamber device for non-invasive ventilation, acute respiratory distress syndrome, and other respiratory-related uses. In a Warning Letter, the Food and Drug Administration told the company that such claims were outside the scope of its 510(k) clearance and, therefore, it was promoting the product unlawfully.1 The device is intended to “provide the use any place that a clinician would normally use a mask for medical purposes of supplying gas/oxygen/air.”

The company made promotional claims on its website, referring and linking to studies, media articles, and television videos that discussed the off-label (i.e. unapproved) uses. Specifically, the company’s website linked to several news articles indicating that “the helmet confers several advantages over the face mask” and “the flood of ventilator mask orders at [the company] requires a ‘scaling up’ of production to meet the demand from hospitals fighting the coronavirus outbreak.” The firm’s YouTube channel also mentioned unapproved ventilation uses.

AGG Observations

  • A company must focus on what the FDA marketing application allows. A 510(k) clearance is not an opportunity to promote anything.
  • A company is responsible and liable for any links to third-party articles or videos that discuss a product’s off-label uses. If the firm controls the message and wants the benefits of that messaging, it assumes the regulatory risks as well. It’s a control thing.
  • A firm must evaluate whether a claim is covered by the scope of the clearance. If it is, the company should document for the file its rationale to promote that claim based on a review of FDA’s regulations and written guidance. It should also assess any safety-related concerns potentially presented. If the change or claim exceeds the 510(k) scope, it must submit a new application.
  • Breathe in, breathe out. Not always so easy.


[1] FDA also cited the company for quality-related and other non-promotional issues, but we will not focus on those deficiencies.