Qnity Medical Applications Policy

 
 
 

Introduction
Qnity provides advanced materials used across multiple industries, including healthcare. Medical applications, particularly those involving implantation or contact with internal body fluids or tissues, carry elevated regulatory and patient safety expectations. This Qnity Medical Applications Policy explains our approach to medical applications and clarifies expectations so that customers can plan responsibly and reduce risk.

Material limitations and regulatory posture
Qnity’s materials are engineered for industrial applications and are not medical grade. Qnity has not performed clinical testing of these materials for implantation and has neither sought nor obtained regulatory clearances or approvals (e.g., US FDA) for use in implanted or internal-contact applications. Qnity does not warrant that its materials are suitable for any medical application and does not assume liability for any use of its material in medical applications.

High risk uses requiring written agreement
Do not use Qnity materials in medical applications involving long-term (more than 29 days)  implantation or contact with internal body fluids or tissues unless the material is supplied under a written contract with Qnity that expressly acknowledges our agreement to supply Qnity materials for the contemplated use. 

Information and regulatory limitations
Qnity does not provide notices, certifications, or documentation asserting material suitability for implantable or internal contact uses, nor does Qnity perform clinical evaluations or regulatory compliance assessments for such applications.

Trademark and product name permissions
The sale of Qnity materials does not convey a license, express or implied, to use any trademark or tradename of Qnity Electronics, Inc. or any of its affiliates, and customers shall not use any trademark or tradename of Qnity Electronics, Inc. or any of its affiliates in the conduct of its business unless expressly authorized by us in a written contract (i.e., a license agreement) and must not imply that Qnity has provided permission, recommendation, or endorsement for any use, including medical applications. 

Customer responsibilities
To support safe and appropriate use of Qnity materials, customers will: engage with Qnity early for all higher risk uses such as implantation or internal tissue/fluid contact; obtain prior written permission for any trademark use; and use evaluations from qualified clinicians, the device manufacturer, and regulatory authorities to determine clinical suitability and regulatory compliance for medical device applications.

Commitment to partnership
Qnity supports responsible innovation. We work with customers to align material capabilities with intended use, clarify documentation limits, and, where appropriate, establish the written agreements and controls required for higher risk medical applications. Our goal is to help customers navigate this sensitive application space with clarity, consistency, and care for patient safety.

 

 
 
 
 
 
 

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