The U. S. Food and Drug Administration's role in contact lens development and safety.
OBJECTIVE
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.


CONCLUSIONS
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.
Saviola
James F
JF
U. S. Food and Drug Administration, Division of Ophthalmic and ENT Devices, Rockville, MD 20850, USA. JZS@CDRH.FDA.GOV
Hilmantel
Gene
G
Rosenthal
A Ralph
AR
D002986:Clinical Trials as Topic; D003261:Contact Lenses; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety; D006801:Humans; D011356:Product Labeling; D011358:Product Surveillance, Postmarketing; D011474:Prosthesis Design; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*