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FDA Information - Revising the Instructions for Use

#1
Hi There,
Could someone please offer some assistance.
If a company was revising the Instructions for Use for a Paediatric Tracheostomy Tube to increase the duration of use from 7 days to 10 days.
What steps would I have to take in order to assess, plan, implement and document this change which complies with the FDA QSR (21 CFR Part 820) regulations.
What impacts would it also have to other QMS elements?
Any help would be appreciated. Thanks
 
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