FDA Updates Guidance on Impact-Resistant Lenses

The Food and Drug Administration has issued a new draft guidance document titled "Impact-Resistant Lenses: Questions and Answers" to explain test procedures, impact-resistant lens testing equipment, recordkeeping, and exemptions to testing of lenses to manufacturers, importers, and consumers. FDA said it will accept comments on the draft, which replaces a guidance issued in 1987, until Jan. 24, 2008.

Copies are available by sending a written request to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850, sending an e-mail to [email protected], or faxing a request to 240-276-3151. John Stigi of the center is the contact for more information at 240-276-3150.

The 24-page document (www.fda.gov/cdrh/dsmica/guidance/23.pdf) contains detailed, updated discussions of lens blanks; semi-finished, finished, and plano lenses; and import entry inspections. It does not set new requirements for manufacturers but does represent the agency's current thinking on impact-resistant lenses, FDA said.

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