2004N-0498 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
FDA Comment Number : EC1
Submitter : Mr. Joseph Masin Date & Time: 02/08/2005 06:02:19
Organization : EID Ltd.
Private Industry
Category :
Issue Areas/Comments
We propose for the FDA to mandate tracking of implanted medical devices by means of Radio Frequency Identification (RFID) tags. The preferred form factor would be so-called microtransponders encaspulated in glass, similar to those being used to identify humans and animals at the present time.
Readability of the identifier will be crucial. In the case of RFID systems, readability is determined by
(1) read range;
(2) the ability to operate in areas of high EMI and
(3) the ability to penetrate living tissue.
Another important requirement will be that (4) the transponders must be uniquely coded in order to ensure positive identification.
Points 1 and in particular 2 call for a low-Q, PSK (phase shift keyed) system with robust performance characteristics.
In order to ensure point 3, a low frequency RFID system will be required. (high frequencies do not penetrate liquids and living tissue well).
For point 4, read-only transponders should be selected over programmable systems, which are more susceptible to inadvertent or unauthorized data modification.