A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of all contact lenses as medical devices, and for other purposes.
Latest Action
Became Public Law No: 109-96.
Official Summary
(This measure has not been amended since it was passed by the Senate on July 29, 2005. The summary of that version is repeated here.) Deems all contact lenses to be medical devices under the Federal Food, Drug, and Cosmetic Act. (Currently, some non-corrective, decorative contact lenses are regulated as cosmetics).
GovScope Watchdog™
AI Government Intelligence™This bill amends the Federal Food, Drug, and Cosmetic Act to classify all contact lenses, including decorative non-corrective lenses, as medical devices. Previously, some decorative lenses were regulated as cosmetics. By reclassifying all contact lenses as medical devices, the bill subjects them to stricter regulatory standards to ensure safety and efficacy under the Food and Drug Administration's (FDA) authority.
The bill standardizes the regulation of all contact lenses as medical devices, enhancing oversight and potentially improving consumer safety.
- All contact lenses, including decorative lenses, are regulated as medical devices under the Federal Food, Drug, and Cosmetic Act.
- The bill removes the previous distinction where some decorative lenses were regulated as cosmetics.
- The FDA gains clear authority to regulate all contact lenses to ensure they meet medical device safety standards.
['Consumers who use contact lenses, through improved safety and regulatory oversight', 'The Food and Drug Administration (FDA), by having clearer regulatory authority', 'Healthcare providers and eye care professionals, through standardized product regulation']
['Implementation challenges in transitioning decorative lenses from cosmetic to medical device regulation', 'Potential increased costs for manufacturers to comply with medical device standards', 'Oversight and enforcement resource requirements for the FDA to regulate all contact lenses']
The bill was passed by the Senate on July 29, 2005, and became Public Law No: 109-96 on November 9, 2005. It reflects a legislative effort to unify regulatory treatment of contact lenses under the FDA to address safety concerns associated with non-corrective lenses previously regulated as cosmetics.
Hidden impact flags detected: 1
GovScope reviewed 1 policy-risk categories. Hover for a quick definition. Click detected flags for bill-specific details.
['Manufacturers of decorative contact lenses may need to invest in compliance with medical device regulations, potentially affecting product availability and pricing.', 'Increased FDA oversight could lead to improved consumer awareness and safer use of all types of contact lenses.', 'Eye care professionals may see changes in prescribing and dispensing practices due to the regulatory shift.']
The bill's reclassification of decorative contact lenses as medical devices centralizes regulatory oversight under the FDA, which may require monitoring to ensure effective enforcement and resource allocation. Transparency in FDA rulemaking and compliance processes will be important to assess the impact on manufacturers and consumers.
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