As a former scientific reviewer within ODE I was not at all surprised to see the internal survey results of how “intended use” and “indication for use” were inconsistently interpreted and applied. This issue has been around and debated internally since the mid to late 80’s and has never truly been addressed directly by the Agency. This inconsistency of interpretation can either cause a major surprise during a 510(k) review or can render a marketed device misbranded and adulterated for being promoted for an unapproved use. This inconsistency deserves the Agency’s highest attention since it can create a major problem for the manufacturer. At one end of the spectrum a finding of not substantially equivalent during a 510(k) review can end a product or a company. At the postmarketing phase of the product lifecycle, a misbranding/adulteration violation of the FD&C act can cause a suspension of sales of the medical device and litigation as a result of a serious injury/death due to use of the medical device for unapproved uses.
On November 22, 2013, 23andMe received a Warning Letter from FDA confirming that it had pursued the incorrect regulatory strategy regarding their Saliva Collection Kit and Personal Genome Service. This letter was not simply an order to stop its practice of selling a product that they believed at one time not to be a medical device, a risk some companies might take, but a letter that communicated to the world that an independent 3rd Party, FDA, believed their product had no merit in diagnosing the potential disease state of patients. This was a clear indictment as to the basic scientific integrity of their product.
This letter should not have been a surprise to the company. It had been in clear communication with FDA for over four years. In addition, in the previous 14 months they had submitted 510(k)s that were clearly being challenged as to the adequacy of the company’s verification/validation testing to support indications for use that had been expanding in the midst of this ongoing regulatory negotiation.