Zdrowie i gospodarka · 01/08/2000
Draft Guidance for Industry on Refractive Implants: Investigational Device Exemptions (IDE's) and Premarket Approval Applications (PMA's); Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Refractive Implants: Investigational Device Exemptions (IDE's) and Premarket Approval Applications (PMA's)." This guidance is neither final nor in effect at this time. This draft guidance describes preclinical and clinical information that may be used in support of IDE's and PMA's.