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 expanded the list of drugs covered under newly flexible compounding policies to include two that may be in short supply because of the COVID-19 pandemic: morphine sulfate and epinephrine.
The Food and Drug Administration issued the first emergency use authorization for a COVID-19 antigen test, which can quickly detect the SARS-CoV-2 virus in a nasal swab sample.
FDA revised its April 3 emergency use authorization for N95 and similar respirators made in China to remove certain respirators that failed to demonstrate at least 95% particulate filtration efficiency when tested by the National Institute for Occupational Safety and Health.
The Food and Drug Administration issued an emergency use authorization to Rutgers Clinical Genomics Laboratory for the first COVID-19 diagnostic test with the option of using home-collected saliva samples.
CMS recently issued new Frequently Asked Questions to aid the Medicaid program and Children's Health Insurance Program in their response to the COVID-19 pandemic.
The Centers for Medicare & Medicaid Services recently issued new Frequently Asked Questions to aid the Medicaid program and Children’s Health Insurance Program in their response to the COVID-19 pandemic.
To streamline the reporting of COVID-19 lab test results, the CDC encouraged all U.S. hospital laboratories to submit their COVID-19 testing information to their state or local public health department following their normal protocol for reportable conditions.
The Centers for Disease Control and Prevention recently launched a webpage to provide information about an agency-developed serologic test to detect SARS-CoV-2 antibodies.
The Food and Drug Administration issued guidance implementing section 3121 of the Coronavirus Aid, Relief, and Economic Security Act, which requires manufacturers to notify FDA of a permanent discontinuance or significant interruption in the manufacture of certain medical devices to prevent or…
The Food and Drug Administration authorized the first serology test in which independent federal data provided the scientific evidence used to support the authorization.