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Unformatted text preview: and has been designed to grow larger, have glossier skin, and to be a darker shade of red than Apple A. In order for Apple B to be considered “substantially equivalent” to Apple A, it must share certain characteristics with Apple A. List and explain four of these characteristics. Fully reference your sources. There are four steps that the new apple must have in order to be considered a “substantial equivalent” of Apple A. Step 1: the new apple must have the same indication statement as the first apple. Step 2: “Does the new device have the same technological characteristics, e.g. design, materials, etc?” Step 3: The new characteristics may not affect safety or effectiveness Step 4: The descriptive characteristics must be precise enough to ensure equivalence....
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This note was uploaded on 02/20/2009 for the course PAM 2300 taught by Professor Avery,r. during the Fall '06 term at Cornell University (Engineering School).
- Fall '06