Unique Device Identification System; Amendment

Document ID: FDA-2011-N-0090-0222
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Labeling, Medical Devices, Reporting and Recordkeeping Requirements
Federal Register Number: 2012-28015
CFR Citation: 21 CFR Part 801
View Document:  View as format pdf View as format html

Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: November 19 2012, at 12:00 AM Eastern Standard Time
Start-End Page: 69393 - 69399
Page Count: 7
Comment Start Date: November 19 2012, at 12:00 AM Eastern Standard Time
Comment Due Date: December 19 2012, at 11:59 PM Eastern Standard Time

Attachments:

Reference 12 Addendum to the Preliminary Regulatory Impact Analysis of the Proposed Rule to Require a Unique Device Identification System

View Attachment: View as format pdf

Reference 13 List of Medical Devices by Product Code that FDA Classifies as Implantable Life Saving and Life Sustaining Devices for Purposes of Section 614 of FDASIA Amending Section 519f of the FDC Act

View Attachment: View as format pdf

Comments

    View All
Total: 28
Horizons Imaging Systems Group - Comment
Posted: 11/26/2012     ID: FDA-2011-N-0090-0230

Dec 19,2012 11:59 PM ET
Consensus Orthopedics, Inc. - Comment
Posted: 12/03/2012     ID: FDA-2011-N-0090-0247

Dec 19,2012 11:59 PM ET
Mark P. Pollock - Comment
Posted: 12/03/2012     ID: FDA-2011-N-0090-0250

Dec 19,2012 11:59 PM ET
Orthopedic Surgical Manufacturers Association (OSMA) - Comment
Posted: 12/11/2012     ID: FDA-2011-N-0090-0252

Dec 19,2012 11:59 PM ET
Orthopedic Surgical Manufacturers Association (OSMA) - Comment
Posted: 12/28/2012     ID: FDA-2011-N-0090-0253

Dec 19,2012 11:59 PM ET

Related Documents

Total: 0
No documents available.