Are condoms regulated by the FDA in US?

In the United States, condoms regulated by FDA, the sale and regulation of condoms are subject to both federal and state policies. Here are key policies and regulations regarding condom sales in American market:

1. FDA Regulation and 510k Listing.

The U.S. Food and Drug Administration (FDA) classifies condoms as IIB level medical devices. This means they must meet specific standards for safety, quality, and effectiveness. The FDA requires every condom manufacturing company to follow stringent testing for strength, durability, and leakage prevention before products can be marketed to consumers.

Condoms must be labeled with specific information regarding their intended use and expiration dates, and each batch is tested to ensure consistency with FDA standards.

2. Age Restrictions (State-Specific)

There are no federal age restrictions for buying condoms; condoms can be sold to individuals of any age. However, some states may have policies affecting access to condoms in specific contexts, like school campuses.

Stores, pharmacies, and other retailers in all states can legally sell condoms over-the-counter.

Each country always has their own authority, Such as FDA, MOH or NAFDAC, and rules for condom registration, we recommend our clients has to registered at first before import from our company, and we also can prepare all the files and sample.