FDA comes under fire for rapid Apple Watch approvals

The Food and Drug Administration’s quick approval of new mobile medical apps designed for the Apple Watch is raising eyebrows among FDA observers who say the tech behemoth got preferential treatment.

Last week, the FDA granted—in two separate letters dated September 11—two different “de novo decisions” in Apple’s favor, according to Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues.

What’s remarkable about the letters, says Thompson, is that Apple apparently filed its electrocardiogram (ECG) clearance application on August 14 and the Irregular Rhythm Notification Feature application on August 9.

Thompson points out that these requests are for first-of-a-kind devices and as a result typically take longer to approve than a follow-on device cleared through the 510(k) process.

“FDA’s goal with regard to reviewing de novo submissions is for FDA to ‘issue a decision within 150 FDA days of receipt of the submission for…50 percent of de novo requests received in FY 2018,’” according to Thompson. “To be clear, that means it’s expected that the other 50 percent will take longer than 150 days. FDA cleared not one but two Apple de novo reviews in fewer than 30 days. That’s remarkable.”

While Thompson acknowledges that the time for FDA review can be shortened by having significant discussions and data sharing with a vendor in advance of an actual filing, he contends that it is “extremely rare to have a review that is less than 30 days.”

In addition, Thompson is suspicious about the timing of the letters—one day prior to Apple’s September 12 launch event for the new products, which were announced in Cupertino, Calif., by Chief Operating Officer Jeff Williams.

“Probably not coincidentally, on September 12, 2018—the very same day that Apple had its big event—FDA issued its own press release in support of what Apple was doing,” adds Thompson. “Others have asked me whether this is typical for FDA to accelerate a clearance review and issue a decision so as to coincide with a company preselected launch date for a new product. I’ve been doing this work for over 30 years, and I’ve never heard of that.”

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Also See: Apple gets FDA approval for new watch, touts health gains

Thompson sent an email last week to the agency inquiring as to whether there is a “new policy of timing” the FDA’s approvals to “support pre-existing, company-selected new product launch dates.” He has not yet received a response.

However, an FDA spokesperson did provide a written statement in response to a query from HDM.

“While we cannot comment on specific interactions with a company, the FDA’s premarket decision is made after the submitter has demonstrated reasonable assurance of the safety and effectiveness of a device,” according to the statement. “That is independent from a company’s decision to announce a product’s marketing authorization or availability. We always encourage manufacturers/developers to communicate and work with the FDA beginning very early in their development process and on a continuing basis using the presubmission process and other interactions. Depending on several factors, such as the level of risk associated with a product, a company’s amount of experience in working with FDA, or how novel a product is, different applicants may interact with the FDA for varying amounts of time.”

The regulatory agency also posted a statement on September 12 from Scott Gottlieb, MD, commissioner of the FDA, and Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, discussing FDA efforts to work with technology vendors to spur innovation in digital health.

“Firms may be new to healthcare products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas,” stated Gottlieb and Shuren. “A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch…The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly.”

At the same time, Gottlieb and Shuren noted in their online statement that “healthcare has been slow to implement disruptive technology tools” and that the FDA’s approach to “regulating these novel, swiftly evolving products” requires the agency to “take modern, flexible, risk-based approaches to regulation in this area, which we hope will reduce the time and cost of market entry, while assuring appropriate patient safeguards are in place.”

Mike Kisch, co-founder and CEO of startup Beddr, whose SleepTuner is an FDA listed Class II medical device, sees the Apple announcement in a positive light generally.

“I applaud the FDA for becoming more progressive and developing programs that allow them to think about products in a different way than they have in the past—and, creating clearer pathways for digital health services and products to get to market,” says Kisch. “I think it’s a fantastic watershed event not only for Apple, but other companies that are in the digital health space who are looking for stronger support from the FDA.”

At the same time, Kisch is left scratching his head about the speed with which the FDA granted approval to Apple’s ECG app for detecting the presence of atrial fibrillation.

“It’s a little interesting to understand why that process moved so quickly—with not that much information—compared with other people in that space who have dedicated devices, specifically, to measure if a person is in AFib,” adds Kisch. “I think there’s some proof to the complaints out there.”

“What I hope hasn’t happened here is that there is a two-class system that has developed to stunt the opportunity for innovation amongst startups—because we don’t have the resources and the clout to push things through as fast as a big company,” he concludes.

In September 2017, the agency selected nine technology vendors—including Apple—to participate in a pilot to help assess how pre-certified companies could bring certain types of consumer and patient apps to market without FDA premarket review or after a more streamlined premarket review process.

While the agency has been working on a new software pre-certification program for developers aimed at fast-tracking digital health products to market, Thompson contends that as of yet the program remains “very broad and vague” with the actual pilot planned for next year.

“So to my knowledge, the only thing that’s happened between FDA and Apple are discussions regarding how to design the program,” he adds. “That should not have had any impact on the clearances.”

Regardless, Thompson says that the FDA “needs to comment publicly on what they’ve done, to allow the entire industry to know what the rules are” going forward. “It’s important that the regulatory process be transparent, and if there are ways to accomplish what Apple accomplished in terms of timing going forward, everyone needs to know of those opportunities,” he concludes.

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