Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex
other · Food and Drug Administration · Rule · Published 2008-11-10 · Effective 2009-01-09 · 73 FR 66522
Document
Document number
E8-26825
Federal Register citation
73 FR 66522
CFR reference
21 CFR 884
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-11-10
Effective date
2009-01-09
HHS docket
Docket No. FDA-2004-N-0511
Abstract
The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled "Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300." The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.