Zdrowie i gospodarka · 14.10.1999
Draft Guidance for Industry on Intraocular Lens; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Intraocular Lens Guidance Document.'' This draft guidance is not final nor is it in effect at this time. This draft guidance describes preclinical and clinical requirements that may be used in support of investigational device exemptions, premarket approval applications, and product development protocols. This draft guidance describes for industry and FDA reviewers the type of information needed to support investigational and marketing applications for intraocular lenses.