The following is a question with an answer from the Centers for Disease Control and Prevention concerning FDA regulations regarding condoms.
"Is it true that FDA does not have specific regulations regarding condoms? Do manufacturers set their own standards (thickness, strength, size, etc.), and if they change standards, they only have to register again with FDA?"
Since 1976, condoms have been regulated under the Medical Device Amendments to the Food, Drug, and Cosmetic Act. Within the FDA, the Center for Devices and Radiological Health is responsible for assuring the safety and effectiveness of condoms as medical devices.
While FDA performance standards have not been established for condoms, FDA does recognize the American Society for Testing and Materials (ASTM) Standard Specifications for Rubber Contraceptives (condoms) D3492-83 as a basis for the condom definition. However, if manufacturers choose to deviate from any of the ASTM specifica- tions, they are required to submit a premarket notification to the FDA at least 90 days before proposing to initiate commercial distribution in the United States.
The FDA has also adapted its inspection sampling criteria to conform with the ASTM Standard D3492-83 for latex condoms. Beginning in the spring of 1987, FDA undertook an expanded program to inspect latex condom manufacturers, repackagers, and importers to evaluate their quality control and testing procedures. In testing condoms, FDA uses a waterleak test in which a condom is filled with 300 ml of water and checked for leaks. FDA criteria and the industry-acceptable quality level for condoms specify that in any given batch, the failure rate must not exceed four leaking condoms per 1000 condoms.
(Centers for Disease Control and Prevention. Training Bulletin #37. March 25, 1993.)
firstname.lastname@example.org (Thu Sep 1 11:35:20 1994)