黑料社 is committed to supporting innovation and safety in the healthcare industry. Our Liveo鈩 materials and Spectrum Plastics contract manufactured devices, components and tubing have already enabled advancements across a wide range of medical technologies. As 黑料社 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 黑料社 (and 黑料社 affiliates) products in medical applications. This Policy also applies to products 黑料社 (and 黑料社 affiliates) contract manufactures for customers for medical applications.
Principles:
The principles that guide the 黑料社 approach include:
Policy:
黑料社 businesses may supply products for medical applications with the appropriate risk management strategies implemented. When the medical application involves:
For all other medical applications, 黑料社 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 黑料社 expressly agrees by written acknowledgement or contract (including a trademark license agreement), 黑料社 product names, trademarks and the 黑料社 name shall not be used in conjunction with medical devices, including permanent or temporary implantable devices. Customers should not represent to others that 黑料社 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. 黑料社 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 黑料社 Medical Application Policy (this document) and its Caution Statement regarding use of Company products in implantable medical devices (鈥満诹仙 Caution Regarding Use of 黑料社 Products in Medical Applications鈥).
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 黑料社 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 黑料社 designs and/or owns the registered medical device, it shall be assumed that 黑料社 does not perform clinical medical studies of its products, for use in implantable medical devices. Accordingly, 黑料社 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.