Hi All,
I would love to hear from anyone in the network who has used the Least Burdensome Flag approach to address a concern with a 510(k) deficiency. We have received a deficiency letter which offers this approach for an informal review by or on behalf of Division management of an issue raised in the AIR.
I believe we have a reasonable point of discussion around the least burdensome approach. However, this is our first 510(k) with this review team and, given that we expect multiple future submissions and interactions with this team, I am concerned that "throwing the flag" and escalating for Division management review may negatively affect future relationships.
While the guidance on Least Burdensome principles is valuable and FDAs webinar on the pilot program from the LB flag is interesting, it only included 2 respondents. I would be interested to hear if anybody has experience with "throwing the flag" outside of the pilot program and how this was received.
many thanks
Kenny
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Kenny Walsh
Galway
Ireland
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