Monday, July 02, 2012

Obamacare - Implantable Radiofrequency Transponder System for Patient Identification and Health Information

Guidance for Industry and FDA Staff
Class II Special Controls Guidance
Document: Implantable
Radiofrequency Transponder
System for Patient Identification
and Health Information

Table of Contents
1. BACKGROUND..................................................................................................................................................1
2. SCOPE..................................................................................................................................................................2
3. RISKS TO HEALTH ..........................................................................................................................................3
4. RECOMMENDED MITIGATION MEASURES ............................................................................................4
A. BIOCOMPATIBILITY ........................................................................................................................................4
B. INFORMATION SECURITY PROCEDURES (DESIGN AND VALIDATION)..............................................................4
C. SOFTWARE VALIDATION ................................................................................................................................5
D. MIGRATION TESTING OF IMPLANTED TRANSPONDER .....................................................................................5
E. PERFORMANCE TESTING OF IMPLANTED TRANSPONDER ................................................................................5
F. PERFORMANCE TESTING OF INSERTER............................................................................................................5
G. PERFORMANCE TESTING AND HAZARD ANALYSIS OF ELECTRONIC SCANNER ...............................................5
H. ELECTROMAGNETIC COMPATIBILITY..............................................................................................................5
I. ELECTRICAL SAFETY PERFORMANCE TESTING...............................................................................................5
J. STERILITY ......................................................................................................................................................6
K. MAGNETIC RESONANCE IMAGING COMPATIBILITY ........................................................................................6
L. LABELING.......................................................................................................................................................6
5. LIMITATIONS OF EXEMPTION FROM PREMARKET NOTIFICATION ............................................7
See for yourself fda.gov

4 comments:

Bob said...

The day they try to plant on of those things into my body is the day I will rise in open revolt.

Not that such a move will change anything, but I will have finally made my postion known about this oppresive federal government and the insane people it supports.

texlahoma said...

Bob - You are not alone. Implants, forced inoculations and gun confiscation will not be tolerated by true Americans. We usually see a bunch of cops surrounding a house, if they try this stuff, we will see cops surrounding a house surrounded by armed citizens, it will get crazy. If it gets to that point, police cars will be nothing but open targets, shot on sight. I hope it doesn't come to that.

texlahoma said...

I guess all this depends on how much people stick together, it might not be like that at all.
If they don't use the police and go straight to the military,(and the military goes along with it) the U. S. will look a lot like Iraq.
Heaven forbid.

sandip said...

Approved by the FDA, a class II implantable device is a "implantable radiofrequency transponder system for patient identification and health information." The purpose of a class II device is to collect data in medical patients such as "claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary."
more information

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