Issue Date: 01/05/2009
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Device Evaluation
On November 10, 2008, the Food and Drug Administration (FDA) published a final rule in the Federal Register, entitled "Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex" (73 FR 66522). This final rule amended the classification regulation for condoms under 21 CFR 884.5300 and designated a special controls guidance document for male condoms made of natural rubber latex without spermicidal lubricant. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121). This guide is intended to provide guidance to small businesses on the requirements of Title 21, Code of Federal Regulations, amended Section 884.5300.