Zdrowie i gospodarka · 20.01.2015

Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types." This draft document provides proposed guidance to industry and FDA staff about the regulation of accessories in medical devices. The guidance explains what FDA considers to be an "accessory," outlines how the risk-based framework for the classification of devices applies to accessories, and describes the use of the de novo classification process for the classification of new types of accessories. This draft guidance is not final nor is it in effect at this time.