Guidelines – RADx℠ Radical https://www.radxrad.org COVID-19 Data Coordination Center Fri, 03 Dec 2021 21:27:32 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 FDA Guidance: Artificial Intelligence (AI) & Machine Learning (ML) in medical devices https://www.radxrad.org/resource/fda-guidance-artificial-intelligence-ai-machine-learning-ml-in-medical-devices/ Thu, 11 Mar 2021 20:13:30 +0000 https://www.radxrad.org/?post_type=resource&p=781 FDA Guidance on Human Factors in Device Development https://www.radxrad.org/resource/fda-guidance-on-human-factors-in-device-development/ Thu, 11 Mar 2021 20:11:21 +0000 https://www.radxrad.org/?post_type=resource&p=779 Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories Surveyor Guidance for New and Modified CLIA Requirements Related to SARS-CoV-2 Test Result Reporting https://www.radxrad.org/resource/clinical-laboratory-improvement-amendments-of-1988-clia-laboratories-surveyor-guidance-for-new-and-modified-clia-requirements-related-to-sars-cov-2-test-result-reporting/ Thu, 11 Mar 2021 20:08:58 +0000 https://www.radxrad.org/?post_type=resource&p=777 Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing https://www.radxrad.org/resource/interim-guidelines-for-collecting-and-handling-of-clinical-specimens-for-covid-19-testing/ Mon, 08 Mar 2021 21:55:15 +0000 https://www.radxrad.org/?post_type=resource&p=323 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing https://www.radxrad.org/resource/idsa-guidelines-on-the-diagnosis-of-covid-19-molecular-diagnostic-testing/ Mon, 08 Mar 2021 21:53:22 +0000 https://www.radxrad.org/?post_type=resource&p=321 HHS Laboratory Data Reporting Guidance for COVID-19 Testing https://www.radxrad.org/resource/hhs-laboratory-data-reporting-guidance-for-covid-19-testing/ Mon, 08 Mar 2021 21:31:25 +0000 https://www.radxrad.org/?post_type=resource&p=295 FDA Guidance: Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 https://www.radxrad.org/resource/fda-guidance-genetic-variants-of-sars-cov-2-may-lead-to-false-negative-results-with-molecular-tests-for-detection-of-sars-cov-2/ Mon, 08 Mar 2021 21:28:16 +0000 https://www.radxrad.org/?post_type=resource&p=289 FDA Guidance: Coronavirus (COVID-19) and Medical Devices https://www.radxrad.org/resource/fda-guidance-coronavirus-covid-19-and-medical-devices/ Mon, 08 Mar 2021 21:25:57 +0000 https://www.radxrad.org/?post_type=resource&p=287