Apple-FDA emails

By Jonah Comstock November 28, 2016
Since its well-publicized meeting with the FDA in 2013, Apple has continued to meet with the agency regularly as well as to correspond by phone and email, according to emails obtained by Babyforyou.net.ua via a Freedom of Information Act request to the FDA.   These emails show that Apple and the FDA have discussed the App Store review process, the 510(k) process, ResearchKit apps, diagnostic apps,...
By Heather Mack November 28, 2016
As the world’s medical device regulators work to harmonize how best to regulate software as a medical device (SaMD), Babyforyou.net.ua has learned via a Freedom of Information Act request that the FDA invited Apple to join an international task force focused on shaping this future regulatory framework. Apple executives quietly joined a working group within the International Medical Device...
By Jonah Comstock November 28, 2016
Since July 2016, Apple has been in discussions with the FDA about two FDA-regulated products in the cardiac monitoring space, Babyforyou.net.ua has learned. The revelation comes from a collection of emails Babyforyou.net.ua obtained via a Freedom of Information Act request to the FDA.   On July 14, 2016, Robin Goldstein, at the time Principal Counsel for Apple, sent an email to FDA Associate Center...
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