Not so fast. What really happened with FDA’s clearance of the Apple Watch ECG

11 October 2018 |


There’s lots of noise about the very rapid de novo clearances for Apple’s “Irregular Rhythm Notification Feature” (DEN 180042) and ECG App (DEN180044) for the Apple Watch.

FDA cleared both applications on the same day, just a month after filing. How could this lightning quick review and clearance be so?

Also, for mobile Apps, FDA guidance stipulates the agency evaluates the software but not the hardware platform. But the latest Apple software relies on hardware sensors in the Apple watch. So surely more was done than a software validation?

The answer to both questions is in clear sight on the FDA website. Take a look at the reclassification orders on the FDA de novo database. You can read them in full here and here (PDF downloads).

The clearance memos show the primary special control for these devices is “Clinical performance testing under anticipated conditions of use”. The ECG requirement goes further, specifying clinical data demonstrating adequate sensitivity and specificity/positive predictive value. These Special controls now apply to future 510(k) applications for these kinds of devices. But more importantly, they will have applied for Apple’s de novo 510(k) submissions.

Plus, there are requirements around hardware compatibility, human factors, and yes – software validation.

And what about the timing – given that clinical trials were involved, surely this needed more than a month of review? This is less suspicious than it may first seem. Anyone contemplating a de novo really needs to talk to FDA about their expectations for data and to confirm that de novo is actually required. It’s pretty much clear that’s what Apple did.

And those presub conversations can go around several loops. (Been there, got the “FDA and Artificial Intelligence T-shirt”). FDA is increasingly using presub processes to work with applicants to agree on testing plans and protocols and do preliminary reviews of actual data. And then right at the end, FDA can process the final formal submission rapidly based on often more than a year of substantive technical conversations.

So, in summary, Apple clearly had to do a lot of work on the software validation, hardware compatibility and also brought Clinical Data. These “quick” approvals were almost certainly the last exchange in a long and detailed conversation.

Another overnight success that was years in the making…

Related Link: Regulation of Medical Software. Click here for a detailed discussion of de novo processes and the commercial implications of regulatory pathways for medical device software.

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