Author

Marco Theobold

Director of Medical Device and Drug Services

FDA Requires Drop Ball Test Certification

Aug 7, 2014

The Food and Drug Administration (FDA) requires proper documentation stating that sunglasses and lenses shipped to the U.S. meet requirements for impact resistance. FDA regulation requires testing a “statistically significant sampling of lenses from each production batch” (21 CFR 801.410(c)(3)) of all non-prescription lenses and plastic prescription lenses using a method known as a “Drop Ball Test”. Registrar Corp detailed the test and result criteria in a previous blog. Each shipment of glasses and/or lenses is required to include a “Drop Ball Test” certificate.

FDA offers suggested wording for the certificate, also known as a “certification statement of impact resistance”, on their website:

(Name of manufacturer or seller) hereby guarantees that the articles listed herein are impact-resistant within the meaning of 21 CFR 801.410 and have been tested pursuant to that section. Impact-resistant lenses are not unbreakable or shatterproof. Records of testing will be maintained for a period of three (3) years from the date of shipment, and copies will be forwarded to FDA upon request.

(Signature and street address of manufacturer or seller)

Along with including the “Drop Ball Test” certificate, companies must be able to submit records of the impact testing results upon FDA request.  FDA may also request to examine shipments for further inspection or sampling.

Failing to include the certificate with your shipment or using a deficient sample size for testing could result in FDA delaying your shipment from reaching its final destination.  Insufficient documentation could even result in a request for a new “Drop Ball Test” performed on samples from the shipment by a third party laboratory in the U.S.

To avoid unnecessary delays or additional costs (e.g., storage fees or drop ball test fees), it is prudent to ensure “Drop Ball Test” results are sufficient and the certificate is attached to your shipping documents every time. For questions related to the “Drop Ball Test” or any other U.S. FDA regulations, contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177. Tweet @RegistrarCorp with specific questions.

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.

Related Article


Subscribe To Our News Feed

To top
This site is registered on wpml.org as a development site. Switch to a production site key to remove this banner.