The FDA recently announced new labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) included in premarket notification (510(k)) submissions.
So why the need for new guidance?
According to the agency’s new recommendations (issued on July 27, 2023), despite the established safety and effectiveness of HPCPs’ over the last few decades, there has been an increase in the number of reported adverse events (AEs) relating to their misuse.
What kind of misuse?
Reports have included HPCP product packaging that “is not easily distinguishable from other lens care products,” which the FDA notes as being a likely culprit behind improper use.
What did the agency do about this?
An FDA panel committee meeting was held back in March 2017 to discuss how to mitigate the potential risk for such devices. Included on the agenda was the importance of:
- Appropriate labeling and packaging
- Clearly communicating the risks of misuse to the consumer and public
- Need for simplicity and clear messaging for warnings / instructions for use
- Ability to identify such bottles by a red tip and red cap for all HPCPs
- Recommendation for a label redesign and standardization
Any other areas?
While not included in the scope of the FDA’s new guidance, the panel also recommended changes to the bottle shape, size, color, physical features, or other characteristics that make HPCPs distinguishable from any other contact lens care products not containing hydrogen peroxide.
So what are the new recommendations on labeling?
The agency recommended simplifying significant warnings and directions for use on the bottle / carton labeling for HPCP solutions by developing a standardization that informs consumers of potential risks.
These changes, the agency emphasized, should be considered for future premarket submissions of HPCPs (current labeling guidance is available here) as well as complement the FDA’s current guide for medical device labeling, available here.
See here and here for contact lens care-specific guidance on 510(k) submissions and product labeling, respectively.
And which specific HPCPs do these apply to?
The new guidance applies to all HPCPs, which are classified into two categories:
- Products, contact lens care, rigid gas permeable (RGP)
- Accessories, soft lens products
What else do they recommend?
Oh there’s a whole lot more on the FDA’s guidance, particularly for labeling HPCPs to ensure any warnings, precautions, and contraindications are crystal clear for consumers.
Click here to read the full, up-to-date document.