Premarket Notification 510(k) Guidance for Contact Lens Care Products
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The draft guidance was initially provided to the public on April 1, 1996, at which time the agency requested comments from interested persons.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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.