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Imprese · 10/11/20081 min di lettura
Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
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.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →