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 Food and Drug Administration authorized the emergency use of the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2.
The Food and Drug Administration warned of methanol’s toxic and “not acceptable” suitability for use as an active ingredient in hand sanitizer. Methanol is a wood alcohol more commonly used for the creation of fuel or antifreeze. FDA said it has seen an increase in methanol’s use in hand sanitizers…
The Food and Drug Administration and Centers for Disease Control and Prevention July 7 at 12 p.m. ET will host a webinar on decontaminating respirators for health care personnel during the COVID-19 pandemic.
The blanket data reporting exceptions and extensions implemented in March across Medicare quality reporting and value-based payment programs for hospitals expired July 1.
The Food and Drug Administration issued guidance for the development of a SARS-CoV-2 vaccine, outlining key considerations to satisfy requirements for chemistry, manufacturing and control, nonclinical and clinical data.
The Food and Drug Administration authorized the emergency use of two COVID-19 molecular diagnostic tests. The tests from Inform Diagnostics Inc. and Diagnostic Solutions Laboratory LLC detect in respiratory specimens nucleic acid from SARS-CoV-2, the virus that causes COVID-19.
SARS-CoV-2 infections may be 10 times higher than reported cases, according to new data from a Centers for Disease Control and Prevention partnership with commercial laboratories to test de-identified clinical blood specimens for antibodies in Connecticut, South Florida, the New York City area,…
The Food and Drug Administration added the AustinP51 emergency-use system to its list of ventilator authorized for emergency use in health care settings to treat adults during the COVID-19 pandemic.
The Centers for Disease Control and Prevention has updated and expanded its list of people at risk of severe COVID-19 illness, the agency said.
AHA today urged the Centers for Medicare & Medicaid Services to temporarily extend certain waivers and make others permanent beyond the COVID-19 public health emergency to allow hospitals to provide better and more cost effective care to their patients and communities.