Zdrowie i gospodarka · 29/12/1994

Obstetrical and Gynecological Devices; Classification of Glans Sheaths

The Food and Drug Administration (FDA) is issuing a final rule classifying glans sheath devices (previously known as ``short condoms'' or ``glans condoms'') into class III (premarket approval). The agency is also responding to comments received on the proposed regulation to classify such devices into class III (57 FR 12908, September 17, 1992). This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) and the Safe Medical Devices Act of 1990 (the SMDA).