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Medical Device Identification and Data Management GS1 Healthcare Conference, Berlin5 April 2017PanelistsLinda Sign, U.S. FDA Associate Director, Informatics Terrie Reed, U.S. FDA Senior Advisor for

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What is medical device identification?

Medical device identification refers to the process of uniquely identifying a medical device in order to trace it throughout its lifecycle.

Who is required to file medical device identification?

Manufacturers, importers, and distributors of medical devices are required to file medical device identification.

How to fill out medical device identification?

Medical device identification can be filled out by providing specific information about the device such as model number, serial number, and manufacturer details.

What is the purpose of medical device identification?

The purpose of medical device identification is to ensure the safety and effectiveness of medical devices by enabling tracking and traceability.

What information must be reported on medical device identification?

Information such as device identifier, production identifier, and manufacturer details must be reported on medical device identification.

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