Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices

Document ID: FDA-2011-N-0661-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Medical Devices
Federal Register Number: 2013-01006
CFR Citation: 21 CFR Part 888
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: January 18 2013, at 12:00 AM Eastern Standard Time
Start-End Page: 4094 - 4100
Page Count: 7
Comment Start Date: January 18 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: April 18 2013, at 11:59 PM Eastern Standard Time

Attachments:

List of References

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Reference 1 Report of the Expert Advisory Group Looking at Soft Tissue Reactions Associated With Metal on Metal Hip Replacements

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Reference 2 Arthroprosthetic Cobaltism Neurological and Cardiac Manifestations in Two Patients with Metal on Metal Arthroplasty A Case Report

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Reference 3 Hip and Knee Arthroplasty Annual Report 2010

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Reference 4 Modern Metal on Metal Hip Implants A Technology Overview

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Reference 5 Failure Rates of Stemmed Metal on Metal Hip Replacements Analysis of Data From the National Joint Registry of England and Wales

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Comments

   
Total: 5
National Research Center for Women & Families - Comment
Posted: 04/26/2013     ID: FDA-2011-N-0661-0005

Apr 18,2013 11:59 PM ET
American Academy of Orthopaedic Surgeons (AAOS) - Comment
Posted: 04/26/2013     ID: FDA-2011-N-0661-0006

Apr 18,2013 11:59 PM ET
Consumers Union - (Multiple Signatures = 11,177 Total) Form Letter Comment
Posted: 04/26/2013     ID: FDA-2011-N-0661-0004

Apr 18,2013 11:59 PM ET
American Association for Justice (AAJ) - Comment
Posted: 04/26/2013     ID: FDA-2011-N-0661-0002

Apr 18,2013 11:59 PM ET
Brent M Ardaugh et al - Comment
Posted: 04/26/2013     ID: FDA-2011-N-0661-0003

Apr 18,2013 11:59 PM ET

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