Intraocular lens guidance
This article was originally published in The Gray Sheet
Clinical studies comparing an investigational IOL to a historical control should have a minimum of 300 subjects, while certain modifications to approved devices would require 100 subjects (1"The Gray Sheet," July 26, p. 6), according to the agency's draft "Intraocular Lens Guidance." Comments are due by Jan. 12, 2000
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