FDA’s Dramatic Announcement of Apple’s Clearances: Is There a Level Playing Field at FDA?


Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, authored an article for LinkedIn, titled “FDA’s Dramatic Announcement of Apple’s Clearances: Is There a Level Playing Field at FDA?”

Following is an excerpt:

The Apple new product announcement yesterday included the revelation that FDA had just granted – in letters dated September 11 – two different “de novo decisions” in Apple’s favor. Apple Chief Operating Officer Jeff Williams announced at the company’s September 12 special event in Cupertino that Apple has received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG that will be built into the company's Series 4 Apple Watch.

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.

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. According to FDA’s performance goals negotiated as a part of the user fee agreement, for 510(k) submissions received in FY 2018, FDA’s goal for the average Total Time to Decision is 124 calendar days. In contrast, 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% of de novo requests received in FY 2018.” To be clear, that means it’s expected that the other 50% will take longer than 150 days. FDA cleared not one but two Apple de novo reviews in about 30 days. That’s remarkable.