Author : The Law The Law Library
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781727701920
Total Pages : 102 pages
Book Rating : 4.7/5 (19 download)
Book Synopsis Unique Device Identification System (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) by : The Law The Law Library
Download or read book Unique Device Identification System (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) written by The Law The Law Library and published by Createspace Independent Publishing Platform. This book was released on 2018-10 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: Unique Device Identification System (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Unique Device Identification System (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. This book contains: - The complete text of the Unique Device Identification System (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section