Replies to post #49276 on Grapefruit USA Inc (GPFT)

[kichwa1]

SMF

This line is Not quite true,

"Even as a layman I understand that equivalence can only be demonstrated by comparing identical (not just equivalent) subjects"

Direct fron the FDA web site

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.

K1