What are some challenges AliveCor faced when preparing your FDA 510(k) application?
Our 510(k) was rather routine, as we positioned our case plus iPhone plus App as a standard cardiac post-event recorder, which means a device that can be used to record an ECG rhythm strip. We felt comfortable that companies like Airstrips and Agamatrix had received 510(k) clearances for iPhone-based devices so we were not the true pioneers.
The AliveCor Heart Monitor also received a CE mark for Conformity in the EU. What were some unique obstacles you faced in applying for the CE mark versus the FDA 510(k) approval?
The CE Mark entails making sure your design and manufacturing meet a specific set of ISO specifications for ECG devices and medical devices. So this means that our contract manufacturer must meet ISO13485, which governs the design and manufacture of medical devices.
Do you think the device will ever be approved for sale over-the-counter?
Yes, we anticipate filing with the FDA for an OTC 510(k) relatively soon and we will not be the first to receive such a clearance for an ECG device.
How complicated will the process be to approve the AliveCor Heart Monitor for the iPhone 5, as well as future iPhones and/or other mobile devices?
As manufacturers change the case designs, we have to adjust our designs. Our electronics remain the same, so the challenge is making sure we meet the quality standards as quickly as possible.
Can you briefly describe the clinical trial results you submitted with your 510(k) application?
We submitted clinical data which we had previously published at the American College of Cardiology and the Heart Rhythm Society Scientific Sessions in 2012 that covered validation of the accuracy and clinical value of our device.
Did the accompanying app have to go through any special approval process?
No, the App was part of our 510(k) application but did not have any separate process. It was designed under FDA-compliant software design controls which has some specific requirements.
Is the AliveCor Heart Monitor subject to any special controls, e.g. special labeling requirements, mandatory performance standards and postmarket surveillance?
Actually, a 510(k) clearance specifically governs how you label the device and the claims you make.
What is the device on which you demonstrated substantial equivalence according to FDA requirements?
Ah, now that is a secret and will await some enterprising entrepreneur filing a FOIA request.