Common use of Regulatory or FDA Compliance Clause in Contracts

Regulatory or FDA Compliance. QIAGEN and Customer agree that the Licensed Materials and Results are not intended to be used as a medical device to directly diagnose a disease or other condition. The Licensed Materials and Results are not intended as a primary diagnostic tool by physicians or to be used as a substitute for professional healthcare advice. The Customer is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditation requirements. In case Customer is using the Licensed Materials as clinical decision support tool to generate patient reports it is the Customer's responsibility to ensure the Results are reviewed by a health care professional, in compliance with such rules, regulations and best practices. QIAGEN shall not be responsible in any manner for ensuring that Customer’s use of the Licensed Materials or Results in the context of Customer’s interpretation of Customer Biological Data complies with the rules and regulations of the US Food and Drug Administration or any other regulatory bodies. Customer shall not represent to any third parties that QIAGEN’s Licensed Materials or Results provide any diagnosis of any disease or condition.

Regulatory or FDA Compliance. QIAGEN and Customer agree that the Licensed Materials and Results are not intended to be used as a medical device to directly diagnose a disease or other condition. The Licensed Materials and Results are not intended as a primary diagnostic tool by physicians or to be used as a substitute for professional healthcare advice. The Customer is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditation requirements. In case Customer is using the Licensed Materials Bioinformatics Offering as clinical decision support tool to generate patient reports it is the Customer's responsibility to ensure the Results are reviewed by a health care professional, in compliance with such rules, rules and regulations and best practices. QIAGEN shall not be responsible in any manner for ensuring that Customer’s use of the Licensed Materials or Results in the context of Customer’s interpretation of Customer Biological Data Variant Samples complies with the rules and regulations of the US Food and Drug Administration or any other regulatory bodies. Customer shall not represent to any third parties that QIAGEN’s Licensed Materials or Results provide any diagnosis of any disease or condition.