The FDA role in contact lens development and safety.
The Food and Drug Administration (FDA) exercises a multifaceted role in fulfilling its mission of enforcing the Federal Food, Drug and Cosmetic Act (Act), functioning not only as industry regulator and consumer protector, but also as scientific advisor and consumer educator regarding medical devices, drugs, foods, cosmetics, and veterinary medicine. Medical devices are regulated within the Center for Devices and Radiological Health. Contact lenses are regulated under the authority of the medical device amendments. The Center is responsible for promulgating regulations, publishing guidelines, and developing written guidance in enforcing the Act, and also for guiding manufacturers of medical devices in safe and effective product development. Other components deal with the compliance of manufacturers with the marketing of medical devices within the meaning of the Act, and through labeling requirements of the Act and consumer education and informational activities. As for contact lenses, the process of updating product development regulations and guidelines is an ongoing activity. The most recent version of the Contact Lens Guideline Document, issued in April 1988, contains two major revisions involving preclinical and clinical testing. The first redefines plastics into one materials category, thus reducing testing requirements with respect to animal toxicology studies and other preclinical areas. The second revision restricts clinical testing requirements to allow confirmatory trials in applications for new daily wear lenses. The intention was to maintain the ability of studies to detect major material or design flaws in lenses, thus boosting confidence in their performance while eliminating unnecessary trials.(ABSTRACT TRUNCATED AT 250 WORDS)
Lippman
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Division of Ophthalmic Devices, U.S. Food and Drug Administration, Rockville, Maryland 20850.
D003261:Contact Lenses / Q000592:standards*; D003262:Contact Lenses, Extended-Wear / Q000592:standards; D004202:Disinfectants; D004869:Equipment Safety; D006678:HIV / Q000187:drug effects; D006801:Humans; D011050:Policy Making; D011634:Public Health; D012965:Sodium Chloride; D014481:United States; D014486:United States Food and Drug Administration
D004202:Disinfectants; D012965:Sodium Chloride