Guidelines for using Syensqo Specialty Polymers in Medical Applications
General Considerations
Only products of Syensqo Specialty Polymers USA, LLC designated as part of the Solviva® family of biomaterials may be considered as candidates for medical applications implanted in the human body and devices that are in contact with body fluids or tissues greater than 24 hours.
Considerations for Use of Syensqo Products
Syensqo has not performed clinical medical studies of the use of these medical grade and products. Moreover, Syensqo has neither sought, nor received, approval from the Food and Drug Administration (FDA) for their use in implants in the human body or in applications in which there is contact with body fluids or tissues.
The suitability of these Solviva® grade products in a given end-use environment is dependent upon various conditions including, without limitation, chemical compatibility, temperature, part design, sterilization method, residual stresses, and external loads. It is the sole responsibility of the manufacturer of the final product, and not Syensqo, to determine the suitability (including biocompatibility) of all raw materials and components, including any Syensqo product, in order to ensure that the final product:
- is biocompatible and otherwise safe for its end use,
- performs or functions as intended, and
- complies with all FDA and other regulatory requirements.
It also is the sole responsibility of the manufacturer of the final end use product to conduct all necessary tests and inspections and to evaluate the final product under actual end-use requirements and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks.
Any decision regarding the appropriateness of a particular medical product in a particular clinical application should be based on the judgment of the manufacturer, seller, the FDA, and the treating physician. Do not rely upon Syensqo. Syensqo cannot weigh the benefits against the risks of a medical device and cannot offer a medical judgment on the safety or efficacy of the use of a Syensqo product in a medical application.
Sterilization
The sterilization method and the number of sterilization cycles a medical device can withstand will vary depending upon type/grade of product, part design, processing parameters, sterilization temperature, and chemical environment. Therefore, the manufacturer of the end use final product must evaluate each device to determine the sterilization method and the number of permissible sterilization cycles appropriate for actual end use requirements and must adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks.
Test Data
Syensqo may contractually agree to provide existing test data and other information about its products or to perform new testing of the products. Such information is to be provided, and such services are to be performed, only pursuant to a written agreement that requires the manufacturer of the end use final product to accept full responsibility for defining the scope of testing and determining the adequacy and appropriateness of the testing for the end use. Such data and information are only preliminary and are not meant to assure the biocompatibility or suitability for use of these products as actually used in the final end use product and do not relieve the manufacturer of its responsibility to properly evaluate its final end-use product under actual end use requirements, nor does it relieve the manufacturer of any of its other responsibilities described in these Guidelines.
Re-Use of Medical Devices
Syensqo does not warrant or represent that single-use medical devices made from a Syensqo medical grade product are suitable for multiple uses. If the medical device is reprocessed and/or labeled for multiple uses, it is the responsibility of the reprocessor and/or manufacturer to determine the appropriate number of permissible uses by evaluating the device under actual sterilization, cleaning, and end-use conditions and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks.
FDA Master Files
If the FDA requires proprietary information about any Syensqo Product as part of the 510(k) clearance or premarket application (PMA) approval process for the manufacturer's end-use final product, Syensqo may establish a Drug or Device Master File and grant a right of reference to it, in order to allow FDA to review such information without disclosing Syensqo's proprietary information to the manufacturer. An authorization to reference a Master File shall only be established pursuant to a written agreement with manufacturer.
Risk of Failure
There is a risk of failure and adverse consequences with all medical devices, including devices implanted in the human body and devices that are in contact with body fluids or tissues.
Disclaimer of Warranty
SYENSQO MAKES NO REPRESENTATION, PROMISE, EXPRESS WARRANTY OR IMPLIED WARRANTY (INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY USE AS MAY BE CONTEMPLATED) CONCERNING THE SUITABILITY OF ANY SYENSQO PRODUCT FOR USE IN MEDICAL APPLICATIONS, INCLUDING AN IMPLANT IN THE HUMAN BODY OR IN APPLICATIONS IN WHICH THERE IS CONTACT WITH BODY FLUIDS OR TISSUES. NO SYENSQO REPRESENTATIVE HAS THE AUTHORITY TO MAKE ANY ORAL REPRESENTATION THAT CONFLICTS WITH ANY PORTION OF THESE GUIDELINES.
Responsibility to Forward These Guidelines
If the purchaser of any Syensqo products is not the manufacturer of the final end use product, it is the responsibility of the purchaser to forward these Guidelines to such manufacturer.