Dear Dr. Keller,

I am sorry but I should like to add one comment for CD 10993-3.

Add the following at the bottom of clause 4.2:
"For testing polymers, the following procedure shall be adopted 
as an alternative: Extract the sample with appropriate organic 
solvents such as methanol, acetone, etc., remove the solvent, 
and apply the evaporation residue to the tests by dissolving it 
in appropriate medium such as a physiological saline, 
culture medium or DMSO."

[REASON]
Japanese Guidelines recommends this procedure. 

AKITADA NAKAMURA, Ph.D.
Director
DIVISION OF MEDICAL DEVICES
NATIONAL INSTITUTE OF HEALTH SCIENCES
Kamiyoga 1-18-1, Setagaya-ku
Tokyo 158, Japan