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FoundationOneCDx
Technical Information
Foundation Medicine, Inc.
150 Second Street, Cambridge, MA 02141
Phone: 617.418.2200
Intended Use
FoundationOneCDx (F1CDx) is a next generation sequencing based
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How to fill out clinical and analytical validation
How to fill out clinical and analytical validation
01
Review the regulatory requirements for clinical and analytical validation.
02
Collect relevant data and samples for validation.
03
Perform the necessary experiments and analysis to validate the accuracy and reliability of the test.
04
Document the validation process and results.
05
Submit the validation data to regulatory authorities for approval.
Who needs clinical and analytical validation?
01
Clinical laboratories, medical device manufacturers, and healthcare providers who develop or use diagnostic tests need clinical and analytical validation to ensure the accuracy and reliability of their tests.
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What is clinical and analytical validation?
Clinical and analytical validation is the process of determining whether a medical test or device is accurate and reliable for its intended use in clinical practice.
Who is required to file clinical and analytical validation?
Healthcare providers and medical device manufacturers are required to file clinical and analytical validation.
How to fill out clinical and analytical validation?
Clinical and analytical validation can be filled out by conducting studies and collecting data to demonstrate the accuracy and reliability of the medical test or device.
What is the purpose of clinical and analytical validation?
The purpose of clinical and analytical validation is to ensure that medical tests and devices provide accurate and reliable results for patient care.
What information must be reported on clinical and analytical validation?
The information to be reported on clinical and analytical validation includes study design, data analysis, and conclusions drawn from the validation studies.
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