Dear Forum,

We just made some minor changes to a product and decided that a new 510(k) is not necessary.

Our distributor asks us if "we need an IRB" ?

As far as I understand, as long as we do not need a new 510(k), we definitely don´t need the involvment of an IRB. Is this correct?

By the way, is this the right place for FDA related questions?

regards
t.

IRBs usually get involved with approving clinical trials and I dont think they have any direct involvemment in the 510(k) process. They may want to know if the device has a 510(k) before allowing a trial to start, or the agency may ask whether clinical trials used for the 510(k) had IRB approval.

Have a look at:
http://www.fda.gov/oc/ohrt/irbs/
http://www.fda.gov/oc/ohrt/irbs/irbreview.pdf