FDA Congratulates Itself on Apple ’s New Medical Apps

In a recent blog post, FDA’s Commissioner Dr. Scott Gottlieb found great merit in the agency’s handling of Apple’s two “marketing authorizations” for medical apps to run on the Watch Series 4. These authorizations were via the DeNovo route to market. Thus, the apps were not “cleared,” which applies to the 510(k) process, and they certainly weren’t “approved,” which is a term reserved for Class III devices that go through Premarket Approval. Gottlieb asserted that these authorizations were “a significant step forward for the agency’s overall approach to the development of digital health.”
It might be noted that Apple’s claim to be first in this arena was challenged by a number of sources including AliveCor, which has made an ECG band for the Apple Watch since 2014, and that device was cleared through a 510(k). However, the AliveCor data must be reviewed by a physician rather than being available to the lay user. In addition, the accuracy of other products of this type has been previously questioned.
It was explained in the blog that these apps were authorized apart from the underlying platform on which they run. This was said to be consistent with “existing guidanc...

Source: MDDI - October 6, 2018 Category: Medical Devices Authors: William A. Hyman Tags: Regulatory and Compliance Source Type: news