Medical Devices; Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff." This document provides guidance to the Center for Devices and Radiological Health (CDRH) staff and to industry whose device is the subject of an open advisory committee meeting. The Federal Advisory Committee Act (FACA) generally requires FDA to make available to the public the information given to panel members, except for material that is exempt under the Freedom of Information Act (FOIA). This draft guidance describes the process CDRH intends to follow when making this information publicly available. This draft guidance also describes how these materials should be assembled and timeframes for their availability. This draft guidance is neither final nor is it in effect at this time.