What are Generics?
GENERIC EQUIVALENT CLAIM: the USAN name of a contact lens material is the basis point for determining what the lens is comprised of from a chemistry perspective. The Clear 58® product is an exact duplicate (etafilcon A). Further to the chemistry of the lens, it is the exact same formulation, meaning that the repeating monomer units are the same which yield the same dK value (within ANSI specification). If any portion of the formulation was even the slightest difference, the USAN council would not allow the contact lens to be classified as the (etafilcon A) material. Furthermore, the manufacturing processes are an exact equivalent, meaning a cast molded contact lens.
FDA PERSPECTIVE
From an FDA 510(k) perspective, we can clearly demonstrate that the two products are not only equivalent and comparable, but that they are an exact duplicate. The Acuvue®2 lens was the predicate device in this submission.
- Marty Dalsing, FDA counsel opinion letter
