News
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Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
This PDF was issued as guidance for industry and FDA staff. It provides useful information such as reporting recommendations, statistical practices, and examples of calculations.
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Regulatory Info for RADx-rad Awardees
This document contains regulatory information for RADx-rad Awardees preparing an EUA submission.
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Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency
Up-to-date COVID-19 policy briefs from the FDA
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FDA Guidance: Artificial Intelligence (AI) & Machine Learning (ML) in medical devices
FDA Guidance for the use of AI and Machine Learning during the COVID-19 Pandemic
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FDA Guidance on Human Factors in Device Development
Guidance on Human Factors and Usability for medical device development
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Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories Surveyor Guidance for New and Modified CLIA Requirements Related to SARS-CoV-2 Test Result Reporting
CLIA Guidelines for SARS-CoV-2 Test Result Reporting
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Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency
Up-to-date Diagnostic FAQs from CLIA
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FDA FAQs on Testing for SARS-CoV2
Up-to-date Diagnostic FAQs from the FDA
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About Emergency Use Authorizations (EUAs)
Starting place to learn about FDA Emergency Use Authorizations (EUAs)
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Diagnostic Core Resources
The RADx-rad DCC Data Core will provide viral standards and variant test panels for awardees. We will also provide benchmarking, usability and LIMS toolkits.