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Following - I am so glad you asked this question as I have asked the same thing to both Ortho and AABB with no direct response. My question was, is there a requirement for an incubator and centrifuge to be an FDA cleared medical device? We use them throughout the lab and blood bank for specimen centrifugation and for serologic tube testing, and those are not FDA cleared devices. As long as your equipment is maintained and is meeting the requirements of the circular/instructions for use, aren't you compliant?

Immucor does that. They underline anything that has changed and use a closed triangle for anything deleted. I've attached a copy of one from 2010. What bugs me we get a new insert in 2016, and it was changed in 2013! Where has it been all this time??changes.pdf