Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments

Information

Type

Rule

Regulated products

Medical Devices

Published

February 27, 2015

Last updated

February 27, 2015

Description

Document number 2015-03943. The Food and Drug Administration (FDA) is amending its regulation regarding postmarket electronic Medical Device Reporting (eMDR) to address the unintentional removal of certain provisions of the Unique Device Identification (UDI) System regulations and to update the contact information listed in the regulations.

Organization

Country / Region

United States

License

Other (Public Domain)

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