Bradley Merrill Thompson Discusses FDA Approval of Apple Watch ECG Monitoring Capability

Yesterday, Apple dropped a bombshell on the digital health world, as it is prone to do in its highly-produced launch events. While the announcement included fall detection on the Apple Watch and some improvements to heart rate monitoring, the headline was definitely the announcement that the Apple Watch Series 4 would contain an FDA-cleared ECG sensor.

While much of the reaction has been positive, longtime watchers of Apple’s health initiatives noticed a few things that didn’t add up: Apple CTO Jeff William’s questionable claim that the ECG is the first of its kind, and the uncanny timing of the announcement and clearance that suggests a new level of industry-government collaboration. …

Some in the industry have also pointed to the speed and timing of the clearances as surprising, and even as evidence of favoritism by the FDA.

“The clearance letters — posted the FDA’s website — are dated September 11. What’s remarkable about them is that Apple apparently filed its ECG clearance application on August 14, 2018, and the Irregular Rhythm Notification Feature application on August 9, 2018,” Bradley Merrill Thompson, a lawyer with Epstein Becker Green who specializes in FDA law, told MobiHealthNews in an email. “For those who may not have background in a De Novo request, these requests are for the first-of-a-kind device and therefore typically take longer to clear 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.’ 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.” …

“[Some] 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,” Thompson said. “I’ve been doing this work for over 30 years, and I’ve never heard of that.” …

If the agency is demonstrating to the industry how much it’s willing to work with innovators, that’s a great sign for the digital health world. But if it’s playing favorites with an old friend, that could be worrying for companies hoping to find the regulatory process a level playing field.

“I think FDA needs to comment publicly on what they’ve done, to allow the entire industry to know what the rules are,” Thompson said. “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.”

mHealth Intelligence, “Apple’s New Smartwatch Gets to the Heart of the mHealth Debate,” by Erick Wicklund.

Becker’s Health IT & CIO Report, “Apple's Latest ECG-Monitoring Watch: 12 Things to Know,” by Julie Spitzer.

POLITICO Morning eHealth, “Inside Apple’s Fast Tracked Clearance,” by Mohana Ravindranath.

MobiHealthNews, “How the FDA is Shaping Healthcare Innovation,” by Laura Lovett.

Healthcare IT News, “How FDA is Evolving to Keep Pace with Innovation in Healthcare,” by Laura Lovett.

Medical Device and Diagnostic Industry (MDDI), “Just Where Does Apple’s New ECG Fit into the Market?” by Omar Ford.

Health Data Management, "FDA Comes Under Fire for Rapid Apple Watch Approvals," by Greg Slabodkin.

POLITICO Morning eHealth, “More Scrutiny on Apple’s Smartwatch Timing,” by Mohana Ravindranath.

FDA Week, "Industry Lawyer Questions Timing of FDA Clearance of Apple Devices," by David Roza.

Dickinson's FDA Webview, "Apple Clearances Timing Raises Questions," by Lee Kramm.

Medtech Insight Pharma Intelligence, "FDA’s Speedy Apple Watch De Novos Raise Questions for Industry," by Ferdous Al-Faruque. (Read the full version - subscription required.)