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US FDA Commish Defends Approach To Apple Approvals

After industry stakeholders raised concerns that Apple may have received preferential treatment when US FDA approved heart-rhythm apps on the Apple Watch Series 4, Commissioner Scott Gottlieb states in a blog post that the agency's approach was in accordance with its standard procedures and reflect the benefit of early interaction with FDA.

Commissioner Gottlieb speaking at RAPS 2017
Scott Gottlieb • Source: Ferdous Al-Faruque

After stakeholders in the medical device industry raised concerns that Apple may have been given preferential treatment to get two de novo classifications in record time, FDA Commissioner Scott Gottlieb penned a lengthy blog post defending the agency's decisions and argued the de novo approvals met the agency's standard review procedures.

Earlier in the month, Apple announced during the launch of its new watch it had received de novo classifications for apps on the device. One of the de novo applicationswas for an app that functions as an electrocardiogram (ECG) while the other is for an algorithm software that is intended to let users know if they are at risk for atrial fibrillation or afib. The reviewers took 30 days from submission to decision and they were completed the day prior to Apple's big launch date for the new watch

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