Update report on intraocular lenses.
Intraocular lenses have been regulated by the Bureau of Devices of the Food and Drug Administration since February 9, 1978. One year ago, data were reported through August 9, 1979, at which time more than 177,000 lenses of four different classes had been implanted. In the meantime, appeals and legal action by the Public Citizens Health Research Group of Washington, DC, have resulted in a re-examination of the intraocular lens issue and the FDA study of the lenses, which has resulted in a delay in any premarket approval, and prohibits the public release of the results of the study to date. This sequence of interesting interactions between physicians, manufacturers, the Food and Drug Administration, and a "consumer" group is outlined.
D003255:Consumer Organizations / Q000331:legislation & jurisprudence*; D006801:Humans; D007221:Industry; D007373:Interinstitutional Relations; D007910:Lenses, Intraocular / Q000639:trends*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence; D013673:Technology Assessment, Biomedical; D014481:United States; D014486:United States Food and Drug Administration