fda-device · Food and Drug Administration · Rule · Published 2016-03-04 · Effective 2016-03-04 · 81 FR 11428
Document
Document number
2016-04707
Federal Register citation
81 FR 11428
CFR reference
21 CFR 801
Type
Rule
Action
Final rule; technical amendment.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-03-04
Effective date
2016-03-04
HHS docket
Docket No. FDA-2011-N-0090
Abstract
The Food and Drug Administration (FDA or Agency) is amending the Unique Device Identification (UDI) System regulation to make editorial changes. This technical amendment updates the email address associated with FDA's UDI system, which allows FDA to obtain information and offer support and assistance on medical devices through their distribution and use, ensuring consistency with the requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This change is necessary to ensure that the UDI team continues to maintain regular email communications with device labelers.