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