FDA Approved Condoms

FDA Approved Condoms? - What does it mean?

The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs and medical appliances. In the simplest terms, “FDA approval” means that the FDA has decided the benefits of the approved item outweigh the potential risks for the item's planned use.

The FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.

Source: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm

Condoms are medical devices?

Condoms are regarded by the United States Food and Drug Administration (FDA) as “Class II medical devices”, this designation also includes pregnancy tests and powered wheelchairs believe it or not. Products in this category have to meet special labeling requirements and performance standards. For condoms, the FDA standards include systematic “water leak” tests to ensure that no fluid can leak out of the condoms. To meet FDA standards, all condoms sold in the US must have at least a 99.6% test score (rating) This basically means that 996 out of 1,000 condoms, on average, must pass this test. FDA-approved condoms must be at least 99.6% effective in laboratory tests to be available to consumers.

Condom Testing

There are lots of ways to test condoms that avoid ethical issues while adhering to high standards of uniformity. These kinds of tests are what all governments use. Some tests measure the durability of the entire condom, some measure only part of the condom, and some test for holes. Some of the more common tests involve testing empty condoms (or putting water in them).

Electrical conductance test

This is a non-destructive test applied to all condoms. Each condom is tested to see if it blocks electricity. An intact condom should not allow electricity to pass through it.

The next tests are all destructive, a tested condom cannot be sold.

Water leak test

Used by the Food and Drug Administration, this test involves filling a condom with 10 ounces of water and looking for leaks.

Tensile test

(stretch test): This method involves slicing a band from the shaft of a condom and testing its stretch-ability

Airburst test

A method used by many European countries, Canada, and now the U.S., inflates the condom with air until it bursts; the maximum volume of air tolerated is used as the measure of strength.

Other tests are of the packaging (package integrity test, lubricant test) and a simulated aging test by warming the wrapped condom in an oven at 70° C.

Regardless of which specific test is used, condom testing involves taking a sample of several condoms from a batch and calculating the fraction that pass the test. The condoms tested are thus a sample (sampling model) of the others in the batch. In the US, a batch of condoms cannot be sold if 5 or more condoms per 1000 fail the test.

FDA Approved Condoms

So, to sum it up, you can be relatively confident that any condom sold in the U.S. (and maintained under proper conditions) will survive the water test and airburst test and should have less than a 5% failure rate (on average)

Source: https://utw10426.utweb.utexas.edu/Topics/Condoms/Text.html

You must also look for the exp dates, lot numbers and health advisories printed on the actual condom packet or foil. FDA requires all condoms in the US to have clearly marked health advisories on every condom sold. If you’d like to be certain, check the condom packet to look for wording about STD and pregnancy prevention. If it’s on the packet, those condoms meet federal regulations for quality and safety (See images below)

FDA Approved condoms health advisories

Prophylactic Compliance

What you need to know before importing condoms – or any other Class II medical device – to the US

Men’s latex condoms are Class II “medical devices” subject to US Food and Drug Administration (FDA) regulation – which makes importing them into the US a complicated endeavor.

For a shipment of condoms – or any Class II medical devices – coming into the US, Customs and Border Protection (CBP) and the FDA will want to see that

a 510(k) Premarket Notification for the devices has been approved by FDA,
the importer of record has filed a Device Initial Importer Registration with FDA, and
the foreign manufacturer has filed a Device Facility Establishment Registration with FDA.

Effective January 1, 2013, two more requirements have been added:

an electronic copy (eCopy) of the Premarket Submission (that is the 510(k) and Premarket Approval applications) 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 eCopy may be a compact disc (CD), digital video disc (DVD), or a flash drive.

Applications to the FDA that are not submitted in eCopy and hardcopy with the cover letter will be rejected.

With these compliance matters, cutting corners becomes expensive very quickly. Failure to comply fully ahead of time – before your shipment arrives in US port – can result in the FDA’s stopping it from getting any further.