COVID-19: CDC, FDA and CMS Guidance
This page includes AHA Today stories and other AHA content on coronavirus COVID-19 guidance from the CDC, FDA, and CMS.
The Centers for Medicare & Medicaid Services Oct. 15 said it will incentivize labs to deliver quicker results to patients undergoing COVID-19 diagnostic testing.
The Food and Drug Administration Oct. 13 issued and immediately implemented enforcement policy for modifications to FDA-cleared molecular influenza and RSV tests during the COVID-19 public health emergency to expand access to certain FDA-cleared molecular tests for detecting and identifying flu…
Ask Your Representatives to Sign ‘Dear Colleague’ Letter Urging HHS to Reinstate June COVID-19 Provider Relief Fund Reporting Requirements
Please contact your representatives today and ask them sign on to a “Dear Colleague” letter to the Department of Health and Human Services (HHS) urging it…
The Centers for Disease Control and Prevention Oct. 22 at 2 p.m. ET will host a Clinician Outreach and Communication Activity webinar on improving clinicians’ understanding the relationship between COVID-19 and the concerns of people who use drugs or who have a substance use disorder.
The Food and Drug Administration Oct. 12 issued an emergency use authorization for Abbott Laboratories’ AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test.
The Centers for Medicare & Medicaid Services Oct. 9 announced a crackdown on labs that are testing for COVID-19 without proper Clinical Laboratory Improvement Amendments certification.
Among 767 hotspot counties for COVID-19 in June and July, early increases in the rate of positive test results for Americans under age 25 were followed by several weeks of rising positivity rates in older age groups, the Centers for Disease Control and Prevention reported.
The Food and Drug Administration recommended that health care providers provide written or video step-by-step instructions, in addition to verbal instructions, to patients who are self-collecting anterior nares (nasal) samples for COVID-19 testing in a health care setting.
The Food and Drug Administration warned Battelle Memorial Institute that its respirator decontamination system does not comply with the requirement in its emergency use authorization to establish internal systems that provide for timely and effective identification, communication and evaluation of…
The Food and Drug Administration released guidance and a briefing document outlining the key data needed to support an emergency use authorization for a COVID-19 vaccine candidate and further explaining the EUA process.