25 min. Read
5.27.22

Who controls the Spice?

In this article:

The inside story of how Apple timed its 2018 de novos in collaboration with the FDA — thanks to its Pre-Cert Pilot Program. Following a series of FOIA requests, E&O analyzed more than 17,000 pages of emails and other documents that Apple and the FDA exchanged between 2013 and 2019 to investigate Apple’s original regulatory clearances.

In December 2015, about 18 months before he became the Commissioner of the FDA, Scott Gottlieb MD wrote a column for Forbes entitled, "Why Apple Dumbs down Your Smartphone."

Gottlieb argued that while Apple "advances the medical promise of its watch

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