The pilot program for the FDA precert framework for software medical devices is still in development, but Apple Inc. scored a win with two apps for its Apple Watch 4 in a remarkably short amount of time. Other companies in the device business, even tech companies toiling in the digital space, might find the quick turn-around time for the de novo applications conspicuous, but the timing of the grant of the de novos was unusual as well.
The FDA posted the granted de novo petitions (here and here) to the agency’s website Sept. 12, the day after the date the petitions were granted. The interesting part of this discussion is that neither premarket filing took more than 33 days, a far shorter amount of time than the average turn-around of 150 days called for under the fourth device user fee agreement.
More conspicuous to some observers, however, was that the agency had posted those de novos on the same day that Apple unveiled the Apple Watch 4, the platform for the two software devices. Regardless of whether one sees the rapid review as more conspicuous than the synchronized announcements, the combination of the two makes it difficult to ignore the possibility that the entire affair was worked out well in advance.
There are clear indications that the de novos had been in the works for some time prior to the nominal filing dates – indeed, FDA Commissioner Scott Gottlieb tweeted that the agency had “worked closely” with Apple during the two software devices’ developmental phases – but Apple had the smarts to hire a consultant with the regulatory chops to help the company avoid choppy regulatory waters. Donna-Bea Tillman, who at one time was the director of the Office of Device Evaluation at the FDA, served as the lead consultant for these projects on behalf of Biologics Consulting Group in Alexandria, Va.
Conspiracy theorists may ultimately have nothing to dissuade them from their suspicions about the timing of all this, but device makers who hope that this signals a new era of cooperation may be likewise disappointed if they are hoping that this is the new normal at the FDA. There are far too many product releases to allow the agency to regularly coordinate with device makers in this manner, but one of the Apple apps is designed to detect atrial fibrillation, which is strongly associated with sudden cardiac death. The agency’s Sept. 12 announcement not only emphasized the need to encourage development in the digital space, but also to “help millions of users identify health concerns more quickly,” thus suggesting the FDA saw a considerable public health benefit in connection with the grant of these de novos.