Determine Appropriate Field Reporting Processes for Medical Device Corrections and Removals

30 May 2014, michigan., United States

Introduction

A review of the relevant sections of the Food, Drug and Cosmetic Act and sections of 21 CFR that FDA utilizes to regulate either the initiation and/or reporting of Medical Device Corrections and Removals, and an overview of status of SG2(PD)/N111R9 guidance document in process to address global harmonization

Venue