Unique Device Identification System (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - Brossura

The Law Library

Brossura

ISBN 10: 1727701925 ISBN 13: 9781727701920

Casa editrice: Createspace Independent Publishing Platform, 2018

Riassunto

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

Dettagli dell?edizione

• Editore: Createspace Independent Publishing Platform
• Data di pubblicazione: 2018
• Lingua: Inglese
• ISBN 10: 1727701925
• ISBN 13: 9781727701920
• Rilegatura: Copertina flessibile
• Numero di pagine: 104
• Contatto del produttore: non disponibile
• Persona responsabile: Yeepin GmbH; 492000000000; sunshine12232@outlook.com; ; Alleestr.11; Kaiserslautern; Rheinland-Pfalz; 67655; Germania