You, the sponsor, should contact the company that owns the information you
would like to incorporate by reference in your premarket submission to FDA, and
find out if this information is currently in a master file. If it is, you should obtain a
written authorization from the master file holder (or an authorized designated
agent/representative) on company letterhead. You should include the original
authorization letter in the original copy of the premarket submission to FDA, and
a copy of the authorization letter in each subsequent copy of the premarket
submission. The master file holder should not send the authorization letter directly
to FDA for inclusion in the master file or for inclusion in your premarket
submission.
If the information you, the sponsor, would like to incorporate by reference in your
premarket submission to FDA is not already in a master file, you should request
that the company that owns this information submit a master file to FDA.
