|
 
Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions.
This final guidance:
- Provides labeling recommendations for manufacturers of hydrogen peroxide-based contact lens care products for inclusion in premarket notification (510(k)) submissions.
- Is intended to help manufacturers develop consumer labeling about specific risks and directions for use of hydrogen peroxide-based contact lens care products in conjunction with a user’s prescribed contact lenses. Clear labeling will help reduce misuse of the product that can lead to patient harm.
- Helps to ensure consumers are provided with clear information about the benefits and risks associated with the use of these devices.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
|
|
|
|
