Issue Date: 05/01/1997
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Device Evaluation
The enclosed GUIDANCE FOR INDUSTRY--PREMARKET NOTIFICATION (510(k)) GUIDANCE DOCUMENT FOR CONTACT LENS CARE PRODUCTS represents the special control which has been determined by the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) as necessary to provide reasonable assurance of the safety and effectiveness of class II contact lens care products (listed below).
This document represents the agency's current thinking on the preparation of 510(k)s for contact lens care products. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
The draft guidance was initially provided to the public on April 1, 1996, at which time the agency requested comments from interested persons. As discussed at the July 26, 1996, meeting of the Ophthalmic Devices Panel (Panel), FDA has evaluated the comments received and has revised the guidance document to incorporate changes resulting from comments determined to have scientific merit.