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# FDA, Apple Met Many Times in Last 3 Years
- URL: https://www.fdaweb.com/fda-apple-met-many-times-in-last-3-years/
- Published: 2016-11-29T12:00:00.000Z
- Updated: 2026-09-14T21:51:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137439

FDA e-mails obtained by MobiHealthNews through a Freedom of Information Act request show that FDA and Apple officials have met many times in the last three years, often with the meetings not shown on agency attendees’ calendars. The MobiHealthNews online [report](http://www.mobihealthnews.com/content/scoop-emails-between-apple-and-fda-hint-future-plans?ref=fdaweb.com) details information in e-mails starting in 12/2013, shortly after a well-publicized meeting between the agency and the company.

“The record shows meeting names and locations were changed, and great consideration was given to when to include top officials, like FDA commissioner **Robert Califf** and **Jeffrey Shuren**, director for the agency’s Center for Devices and Radiological Health, whose calendars are public and might have exposed the company to more media scrutiny,” the report says.

MobiHealthNews says that almost all of the e-mails involve **Bakul Patel**, FDA associate director for digital health. Issues that have been discussed appear to include commercial platforms with sensors and the process Apple uses to review apps made by developers.

MobiHealthNews says it is not clear from the e-mails what topics were discussed at some of the meetings and what the outcomes were. However, it is known that in 10/2014, Patel asked for an Apple representative to a working group under the International Medical Device Regulators Forum that was seeking to harmonize the regulatory approach to standalone medical software.

Discussions between the two sides this year appear to have focused on the international harmonization group and on regulation of new Apple products, including a Parkinson’s diagnostic app and two cardiac devices.