Color Additives and Contact Lenses (Item II)

By Marc Sanchez posted 19-Oct-2011 15:23

Recommend

It is hard to find a contact lens on the market that is not offered tinted. Manufacturers apply for a 510(k) to market and sell their contact lenses. This is an application filed with the FDA in which the manufacturer states what the lenses are made of and how it is safe to use. Included in that list are color additives, usually "listed" color additives. Listed color additives are those provided in the regulations as having been tested and known to be safe in certain quantities. Manufacturers usually list only a handful of colors, but what happens when a manufacturer wants to add a new "listed" color?

To read more on the procedure from the FDA Guidance Document click here.

0 comments

46 views

Permalink

https://connect.raps.org/blogs/marc-sanchez/2011/10/19/color-additives-and-contact-lenses-item-ii

Blogs