Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments
fda-device · Food and Drug Administration · Rule · Published 2015-02-27 · Effective 2015-08-14 · 80 FR 10586
Document
Document number
2015-03943
Federal Register citation
80 FR 10586
CFR reference
21 CFR 803
Type
Rule
Action
Final rule; correcting amendments.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-02-27
Effective date
2015-08-14
HHS docket
Docket No. FDA-2008-N-0393
Abstract
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.