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Anon, yes the forum is meant for regulatory professionals, but this is only one string on a board covering a wide variety of topics, and I have to say it is one of the longest strings I have seen on this  forum. Clearly there is interest and thus, it is totally appropriate. ------------------------------ ...

I am guessing that Anon is asking how many rounds of deficiency questions are possible per module with a modular PMA. I am not aware of a guidance that sets a limit on this. It's been a few years since my last modular, but my experience has been that until a module is closed FDA can always come back ...

Hello All- The 2023 fees have gone up substantially from last year ( especially the 510(k) fee!). Do you think that we can expect a similar jump next year because of general inflation, or is this a result of going from MDUFA IV to MDUFA V, and next year should be less of an increase? Interested to hear ...

Thank you Richard and Barry for your replies.  Appreciate the help. ------------------------------ Julia Anastas San Carlos CA United States ------------------------------

I am aware of SEC reporting requirements on use of conflict minerals (tantalum, tin, tungsten and/or gold), but are there medical device regulatory requirements in the US or elsewhere regarding use of these materials? Many thanks! ------------------------------ Julia Anastas San Carlos CA United ...