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What FDA regulations apply to condoms (those sold and manufactured in the US and those sold and manufactured globally)?
Hello and thanks for asking Wonder about FDA regulations applying to condoms manufactured and sold in the U.S. and abroad. In short, I found that the FDA strictly regulates condoms manufactured domestically and globally. They manage GMP for manufacturers, oversee vigorous testing, and conduct routine inspections. Below, you will find a more extensive account of my findings.
METHODOLOGY
I began my search with the FDA website, which proved to be the most useful resource. I also checked websites of major manufacturers for industry information on regulations, and trusted media sites for articles and current news.
FDA REGULATIONS ON U.S. MANUFACTURERS
First, FDA considers condoms "Class II Medical Devices". 43% of medical devices fall into the Class II category. The FDA categorizes medical devices into three classes: Class I devices are low risk and therefore have the least regulatory control (i.e., tooth floss and bandages); Class II is considered higher risk and therefore having more regulatory control (i.e., condoms, pregnancy tests); and Class III devices have the highest risk with the highest level of regulatory control (i.e., pacemakers, breast implants).
Class II products have to meet specific labeling requirements and performance standards. FDA standards involve “water leak” tests for condoms to make sure fluid does not leak out. The FDA's standard is that 996 out of 1,000 condoms must pass the test. In other words, "FDA-approved condoms must be at least 99.6% effective in laboratory tests to be available to consumers".
Since 1976, FDA has regulated condoms to ensure their safety and effectiveness. But until the 1980's AIDS crisis, rules were not always enforced. Today, FDA regulations oversee condom manufacturing and testing according to strict national standards. Manufacturers now follow good manufacturing practices (GMP), and GMP rules (in the U.S.) are under the jurisdiction of the FDA. Globally, the International Organization for Standardization has ISO 9000 and ISO13485, which covers medical devices, and is widely used to regulate condom production. Specifically, manufacturers test each condom electronically to ensure quality and identify defects. Next, before retailers get the condoms, manufacturers must perform additional random testing on each batch. These tests typically include a "water leak" test to identify holes and "air burst" tests to assess strength. For example, condom manufacturer LifeStyles has an extensive quality assurance process that includes multiple levels of testing at every step, starting with raw materials through packaging. And New Zealand-based Durex claims to conduct 2 million water tests per month. The FDA oversees the manufacturer's testing processes with routine inspections of manufacturing facilities. The FDA also conducts quality tests in its own laboratories.
Even "novelty" condoms have to follow FDA requirements, even if they are labeled as novelties. (The only products that are exempt are those "condom-like" novelty products that cannot be used as a condom. For example, some items are sealed so they cannot be unrolled.)
FDA REGULATIONS ON GLOBAL MANUFACTURERS
The FDA randomly tests imported condoms in agreement with the same strict quality control specifications as condoms produced in the U.S. For imports coming into the U.S., Customs and Border Protection and the FDA require a 1) "510(k) Premarket Notification" that has been FDA- approved, 2) a filed "Device Initial Importer Registration" with the FDA, and 3) a filed "Device Facility Establishment Registration" with the FDA. In 2013, two more requirements were added: 4) a copy of the "Premarket Submission" that must have been "validated by FDA’s eCopy loading system, and the eCopy must be accompanied by a hardcopy of the Premarket Submission documents along with a signed cover letter that states “This eCopy is an exact duplicate of the paper copy.”"
The FDA regulations govern the significant volume of condom imports, and they provide opportunities for foreign manufacturers to prove that their product complies to the quality criteria set by the FDA. There are three levels of "import surveillance and detention" for foreign manufacturers whose product does not meet FDA quality criteria. The FDA has provided ample information for importers regarding each level, including criteria for that level, any actions the FDA may take concerning import detention and admission refusal, and what is acceptable evidence to show that the imported condoms meet FDA’s minimum quality criteria.
Detention status can be removed if certain criteria are met. This will involve private laboratory testing (using FDA’s test methods), and a minimum of five consecutive shipments that meet the FDA criteria.
Additional detailed information and guidelines for imported condoms is as follows, from the FDA website:
In summary, my research has found that the FDA has strict regulations for U.S. and global condom manufacturers alike. Importers are presented with additional hurdles, as outlined above, but are given opportunities to sell their products in the U.S. if they can meet the FDA's quality standards.
Thanks again for asking Wonder. Please let us know if we can help with anything else!