The FDA does not require expiration dating for products without components with a defined effective shelf life, such as batteries. The European Medical Device Directive (MDD) implies that all sterile medical devices must have an expiration date. Therefore, documented shelf life evidence must exist to substantiate those claims.

Accelerated aging testing is based on a thermodynamic temperature coefficient formulated by Von't Hof that states "for every 10 degree C rise in temperature the rate of chemical reaction will double." However, since this formula is based on rate kinetics of a single chemical reaction, not on packages with various kinds of materials, the direct extrapolation of this theory to the aging of packaging materials must be used with caution.
 

The FDA and the package testing industry believe Von’t Hof’s theory is useful in defining and justifying accelerated aging testing services.  Temperature selection for the accelerated aging study should be determined by the temperature that avoids unrealistic failure conditions such as deformation due to melting. Real time aging must be performed in conjunction with any accelerated aging study to correlate the results found during accelerated aging.