Food and Drug Administration Efforts to Mitigate Contact Lens Discomfort
Denise Hampton1, Joffre Angelo Green, Marc Robboy
1Division of Ear, Nose and Throat Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
Abstract:
The premarket review of contact lenses and accessories by the FDA involves the assessment of nonclinical and clinical information in support of clearance or approval of marketing applications. The review process for these medical devices, including attributes, which may contribute to comfort for lens wearers, is summarized, as are mechanisms by which FDA continues to assess and improve recommendations through the review process and through collaboration with external entities.
Insights
The U.S. Food and Drug Administration (FDA) reviews contact lenses and accessories, assessing nonclinical and clinical data for marketing approval. This process ensures safety and efficacy, incorporating wearer comfort factors and continuous improvement through collaboration.
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.
