While we don’t see quite as much Food and Drug Administration enforcement against medical device companies as we see for pharmaceutical firms in the product promotional area, FDA’s Center for Devices and Radiological Health recently issued a Warning Letter to a company for unlawful promotion. Here are some highlights of the letter.

  • The company’s website and product brochure for a 510(k)-cleared medical device promoted the product for major changes in design and in the intended use of the device.
  • The product changes “may incur new risk factors, which would need to be evaluation and mitigated.”
  • CDRH told the company to immediately cease selling the misbranded and adulterated device.

We remind clients that, despite limited personnel resources at CDRH compliance to monitor promotional activities, CDRH will take enforcement action when it believes appropriate. Changes to cleared 510(k) products that might raise potential safety issues and which are promoted to a wide audience, such as on a company website, are likely targets for enforcement. Companies must continue to evaluate product changes to determine if new regulatory submissions are required. Similarly, firms must review all promotional materials distributed, particularly when product changes are made, to ensure regulatory compliance.