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Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments

The Food and Drug Administration (FDA) is amending its regulation regarding postmarket electronic Medical Device Reporting (eMDR) to address the unintentional removal of certain...

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.

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Federal Register Citation

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80 FR 10586

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“Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments,” thefederalregister.org (February 27, 2015), https://thefederalregister.org/documents/2015-03943/medical-device-reporting-electronic-submission-requirements-correcting-amendments.