FDA Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (2009)

This document, published by the United States Food and Drug Administration, outlines amendments regarding the classification regulation for condoms.  This guide is mostly intended to provide guidance to small businesses on the requirements of condom labeling requirements and recommendations.

The changes include:

• updating terminology in the identification section
• creating new classifications sections to distinguish condoms made of natural rubber latex
from condoms made of other materials
• changing the classification of condoms from class II (performance standards) to class II
(special controls)
• designating a guidance document containing labeling recommendations as the special
control for the subset of male condoms made of natural rubber latex.

 

Link to “FDA Designation of Special Controls for Male Condoms Made of Natural Rubber Latex

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