Zdrowie i gospodarka · 11/05/1998

The New 510(k) Paradigm; Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; Availability

The Food and Drug Administration (FDA) has released a new guidance document titled 'The New 510(k) Paradigm' which outlines two alternative methods for demonstrating substantial equivalence in premarket notifications, aiming to conserve review resources and facilitate the introduction of safe devices into the market. The guidance addresses the type of information needed for substantial equivalence determinations, as required by the Center for Devices and Radiological Health (CDRH).