Zdrowie i gospodarka · 01/08/2014

FDA Releases Draft Guidance on Exempting Certain Medical Devices from Premarket Notification Requirements

The Food and Drug Administration (FDA) is releasing a draft guidance document titled "Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements," which outlines the agency's plan to exempt certain medical devices from premarket notification requirements. The FDA believes these devices are safe and effective, and the guidance is not yet final or in effect.