News
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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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Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing
Guidance on sample collection and handling from the CDC
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IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing
Molecular diagnostic testing guidance from the IDSA
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HHS Laboratory Data Reporting Guidance for COVID-19 Testing
Guidance on laboratory reporting from HHS
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FDA Guidance: Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2
Up-to-date Variant guidance from the FDA
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FDA Guidance: Coronavirus (COVID-19) and Medical Devices
FDA guidelines for medical device makers during COVID-19
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