FDA's Speedy Apple Watch De Novos Raise Questions For Industry

Jason Brooke in Medtech Insight

U.S. FDA's unusually fast review of Apple Inc.'s recent software de novo classifications have been hailed as an impressive show of the agency's commitment to digital health. But some stakeholders are concerned Apple was given preferential treatment that could set a troubling precedent.

On Sept. 12, the multinational tech giant unveiled the Apple Watch Series 4, which includes new sensors and software that allow the watch to function as an electrocardiogram (ECG) and uses an atrial fibrillation-detecting algorithm to notify patients if they are at risk for the heart condition. 

The new functionalities were unveiled at Apple's prescheduled, high-profile product launch event at the Steve Jobs Theater in its Apple Park headquarters. The tech company won two de novo classifications for software components in the watch (no approval was necessary for the hardware, FDA says) on the day prior, Sept. 11. This was about 30 days after each of the two submissions were made. For all other FDA de novo submissions completed in 2018 so far, the minimum total decision time has been about three months, but most took between six months to more than two years, according to an analysis by Medtech Insight.

According to a recent media report, Apple was barely able to get the two de novos approved before the launch event. However, the fact Apple was able to get the de novos in the first place at the speed it did is raising eyebrows in the medical industry.

Even though FDA is developing a precertification program specifically to help Software as a Medical Device (SaMD) manufacturers get products to market sooner, in some cases without premarket review, that program is still in pilot stage. Also, while Apple is one of the nine companies that are part of FDA's pilot program, the regulatory agency has confirmed to Medtech Insight its decision was not linked to the pilot.

Jason Brooke, an attorney who has been focused on digital health for a decade and who also works for Navigant Consulting, Inc. and co-founded the medtech company Vasoptic Medical, said the timing of the de novos was striking.

"The first thing that went through my head was how remarkably short the review time was," he said. "When clients ask me how long it will usually take [to get a de novo] I usually tell them it will take six to nine months, which is pretty standard."

A senior official at a major biotech company who follows the combination products field but isn't authorized to speak on the matter, said he has serious concerns about how the de novo applications were reviewed.

"In terms of the way products are approved, especially device products…this is really unprecedented; that was my first thought and then I saw how it correlated with Apple's launch the same day," he said.

The senior biotech official said he tracks such applications closely because his company has an interest in the digital arena because of their work in the combination products field that rely on software. From his perspective, he says it seems clear FDA bent over backwards to help Apple meet their launch date.

"When getting drugs approved, I've certainly never seen it work on the company's timeline," said the executive, adding that he's worked in other industries regulated by FDA and has never seen a similar outcome in those areas either.

"In this case, it's apparent they tried to meet Apple's launch date," he added. 

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