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GUIDANCE DOCUMENT

New FDA Recommendations and Results of Contact Lens Study (7 day letter) May 1989

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

Food and Drug Administration letter to Eyecare Practitioners requesting manufacturers of cosmetic extended wear soft contact lenses to indicate a recommended wearing time of 1 to 7 days in the product labeling, and to strengthen warnings about the risk of ulcerative keratitis and the importance of proper lens care in reducing this risk.


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.