One of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much, you get too high.” Apparently, the Food and Drug Administration came to the same conclusion, substituting “too high” with “too unlawful,” when it issued a Warning Letter to a medical device company that promoted 510(k)-cleared products, such as oxygenators, beyond the cleared uses.¹

We will not discuss the specific violative claims, but we will highlight some of the more noteworthy elements of the Warning Letter.

AGG Observations

• FDA issued the Warning Letter to a company based outside of the United States after an inspection of the ex-U.S. facility. The nexus was that the ex-U.S. company made the products, sold in the U.S., and the U.S. promotional materials and user manuals were found in that facility.
  • An FDA inspection, not a trade complaint or routine monitoring of marketing materials prompted the Warning Letter (as far as we can tell).
  • This was an ex-U.S. facility that manufactured and sold devices for use in the U.S.
  • A Quality System regulation (“QSR”) inspection does not have to be limited to quality and manufacturing issues. Once FDA is in the facility, it has wide discretion in what it can review (although there are limitations on its authority, not discussed here).
• The agency acknowledged the company had a number of cleared 510(k) devices (and, at times, prepared a Letter to File explaining its rationale for not submitting a new 510(k)). However, FDA concluded the promoted uses went beyond the scope of the clearances, as the changes and claims constituted “a major change or modification to its intended use.” It did not help the company that the types of products at issue were used for a specific surgical procedure and were life sustaining.
  • A Letter to File that explains a company’s position not to submit a new 510(k) may help minimize a risk, but it does not eliminate risk if FDA disagrees with the company’s decision.
• FDA did not use the phrase “off-label promotion.” The agency referred to the statutory violations: adulteration (e.g., lack of a Premarket Approval Application) and misbranding (e.g., lack of a cleared 510(k) premarket notification).
• Based on some of the recent Warning Letters, FDA is reviewing promotional materials during inspections, so be prepared. We have written on recent Warning Letters issued to medical device companies for unlawful promotion.²
• FDA notes that the company’s responses to the inspection observations in the FDA Form 483 did not address the product claim violations or were otherwise inadequate regarding QSR violations.
• Yes, “love is like oxygen . . . not enough and you’re gonna die.” FDA continues to remind companies, such as the perfusion system company here, that there are limits to what one can say without FDA review. We are certainly not equating a Warning Letter with death, but it certainly is not love or something that will get you high.

[1] FDA issued the letter to the company on September 29, 2023, but only recently posted the letter on April 30, 2023.  We do not know why FDA waited seven months to post the letter.  The Warning Letter is available here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/spectrum-medical-ltd-666543-09292023.

[2] Other Bulletins on recent Warning Letters issued to medical device companies are available here: https://www.agg.com/news-insights/publications/every-little-one-every-little-one-fda-issues-a-warning-letter-to-a-medical-device-reprocessor-for-changes-to-marketed-products/; https://www.agg.com/news-insights/publications/there-must-be-some-misunderstanding-fda-issues-a-warning-letter-to-a-medical-device-company-that-made-the-wrong-decision-on-regulatory-classification/; https://www.agg.com/news-insights/publications/medical-device-company-falls-and-cant-get-up-fda-issues-warning-letter-to-femoral-hip-manufacturer-for-unlawful-promotion/.