We lead initiatives that properly assess, enhance, promote, and balance contact lens and lens care industry welfare and growth, including the safe use of products in the marketplace.
The principal charter for the Regulatory and Scientific Affairs Committee is to help assess and develop plans of action for opportunities and issues primarily related to FDA and management of standards that may impact the contact lens and lens care industry.
The committee provides a forum for CLI members to assess topical regulatory issues, and develop alignment and tactics to address them. Although primarily focused on FDA policies, regulations and guidance documents, the Regulatory and Scientific Affairs Committee supports projects outside of the FDA domain, especially when topics overlap with FDA initiatives.
Key areas include: periodic face-to-face meetings with FDA and Committee members to discuss industry issues such as peroxide solution labeling to help avoid misuse; recommending changes to FDA Contact Lens and Lens Care Guidance Documents; submitting and presenting Comments at FDA Panel meetings; developing an adverse event decision tree for MDR reporting; address UDI labeling requirements and their potential application to contact lenses and contact lens care products; and participation in ANSI and ISO standards activities by conducting research, publishing test methods, and collaborating on standards development.
The members of the CLI, together with other participating companies participate in a quarterly statistical program to track manufacturer shipment data of Contact Lens and Lens Care products which is managed by Vault Consulting.
The program’s objective is to provide participants with accurate and timely consolidated market data while maintaining the confidentiality of each participant’s individual data. Each participating company in the CLI Statistical Program has a representative on the CLI Global Statistical Task Force. The Task Force determines all the rules guiding the statistical program, such as what data will be collected, reporting instructions, definitions, disclosure guidelines, etc.
This committee undertakes activities related to ethics and compliance matters affecting the U.S. Contact Lens and Lens Care Industry.
The Committee is focused on Sunshine Laws, Ethics Code Implementation and Anti-bribery provisions that impact the Contact Lens and Lens Care Industry.
The Committee has also reviewed AdvaMed and PhRMA ethics guidelines as they may apply to our industry and the ophthalmic community and, where necessary and appropriate, has proactively sought to clarify the guidelines and to educate the ophthalmic community with respect to the guidelines.
Committee members work with the CLI Board to recommend and implement the organization’s communications strategy focused on the delivery of information related to the value of contact lenses, safe use, increasing the visibility of the Institute and sharing CLI-related activities.