Food and Drug Administration Efforts to Mitigate Contact Lens Discomfort

Area of Science:

• Ophthalmic device regulation
• Medical device safety assessment

Background:

• The U.S. Food and Drug Administration (FDA) regulates contact lenses and accessories.
• Premarket review is crucial for ensuring the safety and efficacy of these medical devices.

Purpose of the Study:

• To summarize the FDA's premarket review process for contact lenses and accessories.
• To outline how attributes contributing to wearer comfort are assessed.
• To describe mechanisms for ongoing assessment and improvement of FDA recommendations.

Main Methods:

• Review of nonclinical and clinical data submitted in marketing applications.
• Analysis of device attributes related to lens wearer comfort.
• Examination of FDA's continuous improvement strategies and external collaborations.

Main Results:

• The FDA's review encompasses comprehensive assessment of safety and performance data.
• Factors influencing contact lens wearer comfort are integral to the evaluation.
• The FDA employs ongoing evaluation and collaborative efforts to refine regulatory recommendations.

Conclusions:

• The FDA's premarket review process for contact lenses is thorough, covering critical aspects of device performance and wearer well-being.
• Continuous improvement and external collaboration enhance the regulatory framework for ophthalmic devices.