Are dildos FDA approved?

Dildos are generally classified as Class II medical devices by the U.S. Food and Drug Administration (FDA), which means they typically require FDA approval. However, there are certain cases where they may be exempt from certification, such as:

- When categorized as consumer products not intended for medical use.

- When imported into the U.S. for research or exhibition purposes only.

If a dildo is not submitted for FDA approval, exporting it to the U.S. must comply with several regulatory testing requirements:

CPSC-Related Tests:

1. Phthalates Test: Measures the content of phthalates, a group of chemicals that may pose health risks, particularly developmental hazards to children.

2. Lead Content Test: Determines the amount of lead in the product. Lead is a toxic metal that can damage the nervous system, blood system, and other organs when ingested in excess.

ASTM F963 Tests:

1. Physical and Mechanical Properties Test: Assesses structural integrity, sharp edges, and small parts to ensure the product does not pose risks such as choking hazards during normal or reasonably foreseeable use.

2. Flammability Test: Checks how easily the product ignites to reduce the risk of fire hazards.

3. Toxic Heavy Metals Test: In addition to lead, this includes testing for mercury, cadmium, hexavalent chromium, and other hazardous heavy metals, ensuring their content is within safe limits.

FCC Certification (if applicable):

If the dildo contains electronic components, such as a vibrator, FCC certification is required. This certifies the electromagnetic compatibility (EMC) of the device, ensuring it does not interfere with other electronics and can resist external electromagnetic interference.

California Proposition 65 Testing:

Under California’s Safe Drinking Water and Toxic Enforcement Act, products must be tested for chemicals known to cause cancer, birth defects, or other reproductive harm. This includes certain heavy metals and phthalates. If the levels exceed permissible limits, appropriate warning labels must be affixed to the product.

Packaging Requirements:

Product packaging must also comply with relevant standards—typically needing to be environmentally friendly, deformation-resistant, and free from harmful substances such as lead.

Additional Notes:

If exporting to specific regions in the U.S. or dealing with specific clients, additional requirements may apply. It is recommended that exporters consult with institutions such as China’s JJR Laboratory for complianCE certification and testing services.