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Friday, May 13, 2016

Message to Developers (FDA Deeming...)

NOTE: This cannot be posted directly on Apple's site because it contained the word "tobacco" in the heading.

We license a software-based, multi-platform controller software and hardware that is used, among other things, to control electronic cigarettes we manufacture.  It involves a variety of both proprietary and GPL-based components (used only on the e-cigarette as open source).  Specifically the software I am writing about here uses an iPhone (GRX Controller 1.0), Android, Windows or OS X via Bluetooth or Wifi web page to control the e-cigarettes.  This includes both a display (power levels, etc.) and a controleller (setting power levels).  (Other versions of this run on Windows, Mac, and Android to do the same.)

The FDA recently released these "deeming" regulations that govern this:


These regulations, which did not previously as far as I know include these items, now include "Programmable software" and "Digital display or lights to adjust settings."

They make the software (and perhaps hardware) components involved with "Programmable software" and "Digital display or lights to adjust settings" such as our products and potentially iOS, OS X, Windows, Android, etc. "tobacco products."

It would seem that since the phone or computer are the "digital display" there would be a requirement to follow the above regulations.

It would also seem that some portion of my code and perhaps some or all of iOS, Linux, Windows or Mac OS would now qualify as "programmable software" under these regulations.

We will have to comply ourselves but its unclear to me what the FDA will say about other things it now "deems" to be components of tobacco products.

This potentially means that Linux, iOS, Mac OSX, Windows, and who knows what else will be impacted in unimaginable ways.  "Tobacco products" cannot, as examples, be given away or sold to children.

The deadline for this to begin is August 8th, 2016.

This would be funny if it weren't so serious.

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