Apple worked closely with the Biologics Consulting Group to attain approval for the De Novo request for their new ECG app on the Apple Watch. Apple received approval from the US FDA on 11 September, just one day before the big reveal for the new Apple Watch on 12 September.
Read the letters from the US FDA here:
De Novo is an alternate pathway to classify new devices into Class I or II that had been previously automatically placed in Class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission.
There is also a second De Novo pathway, where a sponsor who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a 510(k).
The granting of the De Novo request allows the device to be marketed immediately, creates a classification regulation for devices of this type, and permits the device to serve as a predicate device.
For more information on the De Novo pathway, check out the following link:
- US FDA
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