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 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.
SARS-CoV-2 may spread from individuals who are presymptomatic or asymptomatic, according to a new Centers for Disease Control and Prevention report based on epidemiologic, virologic and modeling studies before CDC recommended widespread use of face masks.
The CDC updated guidance designed to keep health care personnel safe during the COVID-19 pandemic, along with patient isolation strategies to ensure consistency in CDC’s criteria for patient discontinuation of transmission-based precautions and health care personnel return-to-work guidance.
The Centers for Disease Control and Prevention issued preliminary guidance for the development of forthcoming contact tracing apps that can help slow the spread of COVID-19.