No. Under the regulations, a 1572 is only required for studies of investigational drugs
and biologics conducted under an IND. It is not required for studies that are not done
under an IND, and is not applicable to investigational device studies. Sponsors of device
studies must obtain a signed investigator agreement (containing information similar to
that requested on the 1572) from each participating investigator, per 21 CFR 812.43(c).
