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...
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