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U.S. Food and Drug Administration
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  3. Device Advice: Comprehensive Regulatory Assistance
  4. Guidance Documents (Medical Devices and Radiation-Emitting Products)
  5. Certification Statement of Impact Resistance
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Certification Statement of Impact Resistance

"__________________________________" (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)

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