FDA Says a Medical Device Sterilizer’s Promotion Is Too Hot to Touch

The Food and Drug Administration, channeling Kool & The Gang’s 1979 hit, “Too Hot,” issued a Warning Letter to a medical device company that marketed a sealed sterilization container for unlawful promotion. We will not discuss the specific facts of the particular Warning Letter in this Bulletin, but highlight some of the key points and provide some observations.


  • FDA cleared the medical device for one use. However, the company’s promotion (on its website, for example) suggested new intended uses and created a misleading impression that FDA had evaluated the safety and effectiveness of the device for the new uses.
  • FDA determined that the new intended uses raised serious safety risks (e.g., microbial contamination). FDA noted that, because the device may be used in surgery, the new intended uses could result in patient illness, injury, or death due to the risk of contamination or improper sterilization.
  • In the Warning Letter, FDA noted that, during a previous inspection, it expressed concerns about the company’s promotional claims and the need to submit a new premarket notification (i.e., a 510(k)). However, the company failed to do anything and continued the unlawful promotion.

AGG Observations

  • Despite periodic court challenges to FDA’s authority in the promotional area, particularly in the off-label (i.e., unapproved) arena, this Warning Letter demonstrates that FDA will continue to take action it considers appropriate. FDA can review advertising and promotional materials posted or disseminated in a variety of manners, including on a company product website or in published periodicals. The agency may also review marketing materials during an inspection of the company’s facility. In this case, the agency alleged serious safety risk consequences implicated by the unlawful promotion and cited numerous statements posted on the company’s website.
  • In addition, FDA noted that it gave notice of its concerns to the company and said it needed to submit a premarket submission to allow FDA to evaluate the safety and effectiveness of the new uses, but to no avail. Not listening to FDA was not (and will not be) well received by the agency.

In a nod to Kool & The Gang, the promotion was simply too hot to ignore.

For questions, please contact Alan Minsk.

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