Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit

v9991

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#1
supplier gives us the kit as "ready to fill" state; and in the kit, he does
1. fabricate a major component;​
2. sterilizes 2-other components​
3. has a component which is pre-sterilized​
so the question is,
a. can he take "exclusion" criteria for "design and development" for ISO 13485 section and​
b. what is the need to register himself as an 'device' manufacturer with FDA 820.​
my assessment is that,
a. he should not take exclusion from ISO "design and development"​
b. being 'kit' - with adding value to components, to make it "ready to fill", supplier, my assessment is that he should register himself as an device supplier with FDA​
pl. give reference and guide
 
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pziemlewicz

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#2
There isn't enough information to answer:
  • It's possible for people to put kits together and not be design responsible (i.e. contract manufacturer)
  • Need to understand the function of the kit to determine if they should be registered. If the kit cannot function as a device, and is part of another, it would make sense not to.
 
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