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Contact Lenses and the Food and Drug Administration

Contact Lenses and the Food and Drug Administration

Enactment of the Medical Device Amendments (MDA) was a crucial step in fulfilling the Food and Drug Administration’s (FDA) mission to ensure the safety and effectiveness of drugs and devices available to patients. The MDA established several minimum requirements and directed the FDA to classify all medical devices into one of three classes based on patient risk. Contact lenses have been recognized by the FDA as Class II or Class III medical devices since 1976.

  • Regular-wear contact lenses are Class II medical devices, meaning they pose a moderate risk to patient health when used without appropriate physician oversight.
  • Lenses that can be worn overnight or on an extended-wear schedule are Class III medical devices, meaning they pose a higher risk to patient health and safety when used without appropriate physician oversight.