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Look at the new proposed Rule on intended use to see if this Guidance  will change about what a manufacturer has to do. I did not have time  yesterday to dive in. Has anyone? ------------------------------ Ginger Cantor, MBA, RAC Founder/Principal Consultant Centaur Consulting LLC River Falls, Wisconsin 54022 USA 715-307-1850 centaurconsultingllc@gmail.com ...

Hello, Theoretically if you use symbols from an internationally recognised standard like ISO 15223 according to the Annex I as Anne cited there should be no reason for translation.  But welcome to the real world.  First there is no harmonised standard and would not plan on any for a long time.  Second even the "updated" ISO 15223 has not been published ...

Hello William, Usually that type of training is acquired "on the job" when an employee works for a testing lab or central lab like LabCorp, or from an hospital, or other CLIA/CAP certified labs.  If you are looking for training for your internal employee there are a few options would be seeing if a certified lab does offer training on different types ...

Tier 1 $500k Tier 2 $100k See https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa Sent from my iPhone Sent from my iPhone

Anne and Leo, would you recommend the same if the software were a SaMD and the company supplied customers an android phone with the SaMD installed as an app? ------------------------------ Julie Omohundro, ex-RAC (US, GS), still an MBA Principal Consultant Class Three, LLC Mebane, North Carolina, USA 919-544-3366 (T) 434-964-1614 (C) julie@class3devices.com ...