Company: SciOptic International
Date: 7/9/01

SciOptic has contended that the _____ could be considered as a “custom device” within the meaning of 21 CFR 812.3(b). FDA has previously informed you that the _____ is not a custom device as it does not meet the necessary criteria found in section 520(b) of the Act, or in 21 CFR 812.3 of the implementing regulations. In addition, FDA has previously viewed any software specifically intended for use in designing contact lenses as a medical device and subject to premarket notification [510(k)] requirements.

FDA District: Rockville, Maryland