Date: Fri, 22 Jul 94
From: Jonathan Jacky
To: Principal Investigators, NCI Radiotherapy Treatment Planning Tools
contract
Subject: FDA and RTPT tools

Helen Stone at NCI just sent me a copy of a letter to her from Steven
M.  Niedelman, Acting Directory, Division of Enforcement II, Office of
Compliance, Center for Device and Radiological Health, FDA.  It's
dated July 12, 1994.  Some excerpts:

"... It is the FDA's position that the NCI can legally distribute the
Tools to the nine NCI-funded institutions known as the 3D Oncology
Group for use in studies conducted under investigational protocols
reviewed and approved by the appropriate Investigational Review Boards
(IRB).  It is not necessary that the NCI itself obtain IDE
(Investigational Device Exemption) clearance for use of the tools in
these studies.  IRB clearance should be obtained locally by the
individual participating investigators."

"... Dr. Zink's letter also asked whether the tools could be distributed
to a few NCI funded institutions which are carrying out other research
in 3D conformal radiation ... It is the FDA's position that the NCI
can legally distribute the Tools to these NCI funded or other
institutions which are carrying out research apart from that being
performed by the 3D Oncology Group with the proviso that the Tools are
labelled "For Investigational Use Only." "

"... It is the FDA's position that the NCI can distribute the Tools,
without having a cleared premarket notification [510(k)], to
manufacturers of commercial therapy planning systems.  Because the
Tools are not usable by themselves, but require the development of a
foundation interface appropriate for and unique to each therapy
planning system, we do not consider the Tools to be finished devices."