DuPont Teiiin Films POLICY Regarding Medical
Applications of DuPont Teijin Films Materials
(January 1, 2008)
DuPont Teijin Films is continuing its Policy regarding
medical applications of DuPont Teijin Films materials and the following
clarifies the Policy language based on more than a decade of experience. This
Policy does not affect customers who use DuPont Teijin Films materials in
medical articles unless the application involves implantation in the human body
or contact with internal body fluids or tissues (Categories A and B below).
PRINCIPLES:
Several principles guide the DuPont Teijin Films
approach to this area:
•
We encourage business relationships within the health
care industry that result in delivery of high value medical products.
•
We seek to maintain safety where we are involved in
the health care industry.
•
We seek to maintain positive relationships with FDA
and other regulatory agencies.
•
We continually seek to identify areas where our
businesses can contribute to the health care industry.
CATEGORIES:
DuPont Teijin Films categorizes Medical Applications
into the following three (3) categories:
Category A: Medical Applications involving permanent implantation
(more than 30 days) in the human body or permanent contact with internal human
body fluids or tissues;
DuPont Teijin Films may supply materials for a
Category A application where DuPont Teijin Films is the owner, designer or
manufacturer of the medical device, or there is an approved DuPont Teijin Films
development program, or where the structure of the business relationship, or
other business risk management strategies are determined to adequately manage
the business risks. The decision whether particular business risk management
strategies are adequate shall be made at the corporate level, at the sole
discretion of DuPont Teijin Films, on a case by case basis, and shall not be
made at the business unit level.
DuPont Teijin Films business units will not supply
standard materials under ordinary terms to firms using such materials for
medical applications involving permanent implantation in the human body. If
customers, distributors or resellers fail to comply with this Policy, then
DuPont Teijin Films business units shall discourage their use of DuPont Teijin
Films materials.
Category B: Medical Applications involving
brief or temporary implantation (30 days or less) in the human body and more
than transient or minimal contact with internal human body fluids or tissues;
DuPont Teijin Films strategic business units may
decide to supply materials to customers. DuPont Teijin Films will not supply
materials to customers with Category B applications unless the material is
provided under the corporate risk management contract and other specific
corporate risk management conditions are met. Permission to refer to material
Master Files is restricted.