Author

Marco Theobold

Director of Medical Device and Drug Services

Manufacturers, Exporters and Initial Importers/Distributors of Sunglasses and Lenses—Did You Know?

Feb 22, 2012

The Food and Drug Administration (FDA) reviews shipments of sunglasses and lenses to check for proper documentation. FDA requires shipments of glasses and/or lenses include the “Drop Ball Test” certificate with it.

The FDA regulates eye wear products to ensure their safety. Impact resistance is an essential criterion for U.S. bound glasses and/or lenses. The FDA does not explicitly define a number of lenses that need to be tested before approved; it depends on the size of the shipment and the material/type of lens. However, the FDA does state that the drop ball test must be performed on every glass lens for prescription use.

There is a guidance document for the drop ball test. The regulation states the following requirements:

1. The impact test will consist of a 5/8 inch steel ball weighing approximately 0.56 ounces
2. The ball should be dropped from a height of 50 inches from the horizontal upper surface of the lens
3. The geometric center of the lens should be struck by the ball within a 5/8 inch diameter circle
4. There cannot be anything restricting the fall of the ball
5. A tube may be used to guide the ball to the lens; the ball may be dropped through a tube extending to within approximately 4 inches of the lens

Title 21 of the FDA’s Code of Federal Regulations states that the lens cannot fracture on impact in order to pass the test. A lens is considered fractured if:

1. It cracks through its entire thickness, including a laminar layer, if any, and across a complete diameter into two or more separate pieces; or
2. Any lens material visible to the naked eye becomes detached from the ocular surface (i.e., the surface of the lens that is closest to the eye when the lens is in actual use).

A failure to include the “Drop Ball” certificate with your shipment can result in a delay in your shipment by the FDA. To avoid any delays make sure the Drop Ball Test results are attached to your shipping documents.

For questions related to the “Drop Ball Test” or any U.S. FDA regulation, please contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.

Author


Marco Theobold

Director of Medical Device and Drug Services

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.

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