Is an R&D company subject to FDA regulation when licensing and not manufacturing?

N

n00bie

#11
I hope this isn't too off topic and can start a new thread. :)

But what would be the situation for Google and the Smart Lens? They are providing the R&D to Novartis who will manufacturer the contact lens. Would they be classified as a Specification Developer? Will Google be subjected to FDA audits?
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
I hope this isn't too off topic and can start a new thread. :)

But what would be the situation for Google and the Smart Lens? They are providing the R&D to Novartis who will manufacturer the contact lens. Would they be classified as a Specification Developer? Will Google be subjected to FDA audits?
http://www.novartis.com/newsroom/media-releases/en/2014/1824836.shtml :

The smart lens technology involves non-invasive sensors, microchips and other miniaturized electronics which are embedded within contact lenses. Novartis' interest in this technology is currently focused in two areas:

  • Helping diabetic patients manage their disease by providing a continuous, minimally invasive measurement of the body's glucose levels via a "smart contact lens" which is designed to measure tear fluid in the eye and connects wirelessly with a mobile device;
  • For people living with presbyopia who can no longer read without glasses, the "smart lens" has the potential to provide accommodative vision correction to help restore the eye's natural autofocus on near objects in the form of an accommodative contact lens or intraocular lens as part of the refractive cataract treatment.
If Google are eventually involved in the manufacture of the smart lens, I reckon that they will be a critical supplier to Alcon (Novartis), or maybe even a Contract Manufacturer in the regulatory sense, and as such FDA may inspect them. If they're not involved, or only slightly involved, in the manufacture, they will be "just another supplier" - albeit of R&D services - so as long as Alcon has a proper DHF and a proper DMR there'll be no special reason to inspect Google.

If the eventual device is sold under Novartis' name Google won't be considered a Specification Developer.

Cheers,
Ronen.
 
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