MicroChem General and Medical Disclaimer Statement
MicroChem General Disclaimer
Unless MicroChem specifically and expressly contracts in writing with the customer for a particular intended use of our product, the choice of our product for any particular intended use is the sole and exclusive responsibility of the customer; and MicroChem shall in no event ever have any responsibility for, nor incur any liability for any particular use or application of its product by the customer absent such a specific and express written contractual agreement otherwise.
MicroChem CAUTION Regarding Medical Applications of MicroChem Materials
UNLESS OTHERWISE EXPLICITLY SPECIFIED IN CURRENT, APPLICABLE MICROCHEM PRODUCT DATA SHEETS OR APPLICATIONS LITERATURE, MICROCHEM MAKES NO CLAIM THAT ITS MATERIALS ARE CERTIFIED BIO-COMPATIBLE OR OTHERWISE INTENDED FOR USE IN ANY MEDICAL DEVICE OR OTHER MEDICAL PRODUCT. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING: DO NOT USE MICROCHEM PRODUCTS OR MATERIALS IN ANY MEDICAL APPLICATIONS INVOLVING IMPLANTATION IN THE HUMAN BODY OR ANY ANIMALS, OR CONTACT WITH INTERNAL BODY FLUIDS OR TISSUES UNLESS THE SAME HAS BEEN PROVIDED BY MICROCHEM UNDER A WRITTEN CONTRACT THAT IS CONSISTENT WITH THE MICROCHEM POLICY REGARDING MEDICAL APPLICATIONS, AND MICROCHEM SPECIFICALLY AND EXPRESSLY ACKNOWLEDGES AND AGREES TO THE CUSTOMER'S PARTICULAR CONTEMPLATED USE. OTHERWISE, MICROCHEM MATERIALS ARE NOT DESIGNED OR MANUFACTURED FOR ANY SUCH USE.
MICROCHEM MAKES NO REPRESENTATION, PROMISE, EXPRESS WARRANTY OR IMPLIED WARRANTY CONCERNING THE SUITABILITY OF THESE MATERIALS FOR ANY MEDICAL USE INCLUDING, WITHOUT LIMITATION, IMPLANTATION IN THE HUMAN BODY OR ANY ANIMALS, OR CONTACT WITH INTERNAL BODY FLUIDS OR TISSUES.
MICROCHEM MATERIALS ARE NOT CERTIFIED FOR IMPLANTS.
MicroChem has not performed clinical testing of any of its materials. MicroChem will not provide customers making implantable devices any notice concerning its materials, as specified under United States Code of Federal Regulations 21 C.F.R. section 820.50, or any other information necessary for medical-device use of the materials under any other statute or FDA or other regulation. MicroChem has neither sought, nor received, approval from the FDA or any other governmental agency for the use of these materials in implantation in the human body or any animals, or in contact with internal body fluids or tissues.
DO NOT MAKE REFERENCE TO THE MICROCHEM NAME OR ANY MICROCHEM TRADEMARK IN ASSOCIATION WITH AN IMPLANTABLE MEDICAL DEVICE.
Do not use a MicroChem trademark as the descriptive name of an implantable medical device.
ALL MEDICAL DEVICES, INCLUDING IMPLANTABLE MEDICAL DEVICES, CARRY A RISK OF FAILURE AND ADVERSE CONSEQUENCES.
Regarding implantation of materials, you should rely upon the medical judgment of the physician, the medical device seller and the FDA. Do not rely upon MicroChem in any medical matters including, without limitation, implantation. Examples of both harmful consequences and life-saving benefits from the implantation of various materials can be found in published medical articles. MicroChem does not perform clinical medical studies of any implantable medical devices. MicroChem cannot weigh the benefits against the risks of a device, nor can it offer a medical judgment on the safety or efficacy of the use of our material in a medical device of any kind or nature.
MicroChem has received a number of inquiries about the use of its products for particular applications, including medical applications and, more particularly, their use by manufacturers of implantable medical devices (the "Devices"). MicroChem has determined that unpredictable and excessive costs of doing business with such customers and manufacturers does not justify MCC's unrestricted sale of raw materials to such customers and manufacturers at customary prices. It is the purpose of this policy to publicize this position to prospective customers of MCC products. The balance of this policy statement will focus on medical applications generally and, more specifically, medical applications which produce products intended for implantation in the human body or in animals.
In order to manage business risk in this area MicroChem will not supply MicroChem materials in the ordinary course of business to firms using such materials for medical applications involving permanent implantation in the human body or in any animals (other than laboratory animals used for experimental purposes). There are exceptions to this rule where MCC has expressly contracted with a customer for a specifically identified application, which MCC will do when, in its own discretion and business judgment, the business-risk-management strategies are adequate to justify a supplier/customer relationship.