DuPont de Nemours Statement on Use of DuPont Materials in Medical Applications

DuPont is committed to supporting innovation and safety in the healthcare industry. Our Liveo™ materials and Spectrum Plastics contract manufactured devices, components and tubing have already enabled advancements across a wide range of medical technologies. As DuPont advances to further support the healthcare industry through a wide range of other innovative products and precision contract manufacturing engagements, it remains committed to diligently evaluating new opportunities and being a trusted supplier.

Our Medical Applications Policy supports customer relationships that are committed to the responsible delivery of products for essential healthcare applications and have demonstrated capabilities and resources to deliver on those commitments.

For more information, please see our Medical Applications Policy and corresponding Caution Statement below.

This Policy applies to the use of DuPont (and DuPont affiliates) products in medical applications.  This Policy also applies to products DuPont (and DuPont affiliates) contract manufactures for customers for medical applications.

Principles:
The principles that guide the DuPont approach include:

• We are committed to safety in our business and in the health care industry.
• We encourage business relationships within the health care industry that result in delivery of essential medical products.
• We continually seek to identify areas where our Businesses can contribute to the health care industry.

Policy:
DuPont businesses may supply products for medical applications with the appropriate risk management strategies implemented.  When the medical application involves:

• U.S. FDA Class III medical devices (devices used to sustain or support life, are implanted or present potential unreasonable risk of illness or injury)
• Implantation in the human body for more than 29 days, or
• Contact with human tissue or bodily fluids for more than 29 days, then the business risk management strategy will be developed by the business and is approved at the corporate level.

For all other medical applications, DuPont businesses may decide at their discretion if risk management is adequate and will use normal sound business judgment in forming supplier/customer relationships.

Trade Names, Master Files and Caution Statement:
Unless DuPont expressly agrees by written acknowledgement or contract (including a trademark license agreement), DuPont product names, trademarks and the DuPont name shall not be used in conjunction with medical devices, including permanent or temporary implantable devices.  Customers should not represent to others that DuPont permits, recommends, or endorses the use of our products in implantable medical devices. Permission for any customer to refer to an FDA Master File must be obtained in writing for each individual application. DuPont customers producing FDA Class III devices or components going into such devices or devices implanted into the human body for more than 29 days  or that will be in contact with human tissue or bodily fluids for more than 29 days shall receive a copy of DuPont  Medical Application Policy (this document) and its Caution Statement regarding use of Company products in implantable medical devices (“DuPont Caution Regarding Use of DuPont Products in Medical Applications”).

DO NOT USE DUPONT PRODUCTS IN MEDICAL APPLICATIONS INVOLVING PERMANENT IMPLANTATION (more than 29 days) IN THE HUMAN BODY OR CONTACT WITH INTERNAL BODY FLUIDS OR TISSUES (more than 29 days) UNLESS THE PRODUCT HAS BEEN PROVIDED FROM DUPONT UNDER A WRITTEN CONTRACT THAT IS CONSISTENT WITH THE DUPONT POLICY REGARDING MEDICAL APPLICATIONS AND EXPRESSLY ACKNOWLEDGES THE CONTEMPLATED USE.

DUPONT MAKES NO REPRESENTATION, PROMISE, EXPRESSED WARRANTY OR IMPLIED WARRANTY CONCERNING THE SUITABILITY OF PRODUCTS FOR USE IN IMPLANTATION IN THE HUMAN BODY OR IN CONTACT WITH BODY FLUIDS OR TISSUES.

DO NOT MAKE REFERENCE TO THE DUPONT NAME OR ANY DUPONT TRADEMARK IN ASSOCIATION WITH AN IMPLANTABLE MEDICAL DEVICE.

Do not use a DuPont trademark associated with the descriptive name of an implantable medical device. 

ALL IMPLANTABLE MEDICAL DEVICES CARRY A RISK OF FAILURE AND ADVERSE CONSEQUENCES.

Examples of harmful consequences and life-saving benefits from the implantation of various medical devices can be found in published medical articles. Unless DuPont designs and/or owns the registered medical device, it shall be assumed that DuPont does not perform clinical medical studies of its products, for use in implantable medical devices.  Accordingly, DuPont cannot weigh the benefits against the risks for such devices and cannot offer a medical assessment of the safety or effectiveness of our products in such medical devices.