S
s.parakos
I am curious how other members handle changes to a DMR:
Do you create a Concession for ANY document change in the DMR?
I understand that the purpose of Concessions is to allow manufacturers to keep selling product with minor nonconformities. But once a Device is released does the FDA expect to see any changes in a DMR recorded as a concession?
I can imagine changes to documents which improve manufacturing for instance, but do not change the form, fit or function - how do people handle these?
Or how about a minor typo in a Device Manual - technically a change in form?
thanks
Simon
Do you create a Concession for ANY document change in the DMR?
I understand that the purpose of Concessions is to allow manufacturers to keep selling product with minor nonconformities. But once a Device is released does the FDA expect to see any changes in a DMR recorded as a concession?
I can imagine changes to documents which improve manufacturing for instance, but do not change the form, fit or function - how do people handle these?
Or how about a minor typo in a Device Manual - technically a change in form?
thanks
Simon