CONTENTS: SESSION VI: HOW POPULAR WILL CONTINUOUS WEAR BECOME?The U. S. Food and Drug Administration’s Role in Contact Lens Development and SafetySaviola, James F. O.D.; Hilmantel, Gene O.D., M.S.; Rosenthal, A. Ralph M.D.Author Information From the U. S. Food and Drug Administration, Division of Ophthalmic and ENT Devices, Rockville, MD. Accepted September 27, 2002. Address correspondence to: James F. Saviola, O.D., Food and Drug Administration, CDRH/ODE/DOED, HFZ-460, Room 250N, 9200 Corporate Blvd., Rockville, MD 20850. Phone: (301) 594-1744; fax: (301) 827-4601; e-mail: [email protected] This paper represents the professional opinion of the authors and is not an official document, guidance, or policy of the U.S. Government, the Department of Health and Human Services, or the Food and Drug Administration, nor should any official endorsement be inferred. Eye & Contact Lens: Science & Clinical Practice: January 2003 - Volume 29 - Issue 1 - p S160-S165 Buy Abstract Purpose. To provide information concerning the U. S. Food and Drug Administration’s (FDA) role as a regulatory agency in the development and safe use of contact lenses. Methods. The FDA’s organizational structure and regulatory classification of medical devices are explained. Specific regulatory authorities are described and examples provided with respect to the FDA’s role in the regulation of the new hyper-oxygen permeable continuous wear contact lenses. Results. The application of medical device regulations addresses the rights and safety of subjects in preapproval clinical studies and provides a basis to generate valid scientific evidence to demonstrate the safety and effectiveness of a medical device. Once on the market, there are postmarket requirements with which a manufacturer must comply. Conclusion. For continuous wear 30-day lenses, the FDA is using additional regulatory authorities new to the contact lens area to assure that product safety is maintained and consumer information is improved. These include postapproval studies, more informative labeling, and advertising restrictions. Whereas it is the FDA’s mission to promote and protect the health of the public by ensuring the safety and effectiveness of medical devices, the agency works in partnership with other stakeholders to maintain the safe use of medical devices. © 2003 Lippincott Williams & Wilkins, Inc.