Zdrowie i gospodarka · 01/08/2000

FDA Releases Draft Guidance on Refractive Implants and IDE/PMA Applications

The Food and Drug Administration (FDA) has released a draft guidance document outlining the requirements for Investigational Device Exemptions (IDE's) and Premarket Approval Applications (PMA's) for refractive implants. The document provides preclinical and clinical information that may be used to support these applications.