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 Disease Control and Prevention adjusted its guidance for fully vaccinated individuals, urging indoor masking in states that are labeled as 鈥渉igh鈥 or 鈥渟ubstantial鈥 in their number of cases, including schools, where all in attendance should wear masks.
The Food and Drug Administration issued an emergency use authorization to Becton, Dickinson and Company for its sodium citrate blood specimen collection tubes for coagulation testing by authorized laboratories for COVID-19 and other patients.
Pfizer said its COVID-19 vaccine will receive a priority review from the Food and Drug Administration, indicating that Pfizer has completed its rolling submission of its application for the vaccine鈥檚 full authorization.
The Food and Drug Administration revoked its emergency use authorization for the Curative SARS-Cov-2 Assay test because the manufacturer has transitioned to using other authorized tests for testing offered at its laboratories.
The Centers for Disease Control and Prevention鈥檚 Advisory Committee on Immunization Practices will convene July 22 to discuss a pair of recent issues related to COVID-19 vaccines.
Johnson & Johnson was notified that the Food and Drug Administration now will require that the company add to the label of its COVID-19 vaccine a warning of a small, increased risk of Guillain-Barr茅 syndrome, a rare but potentially serious neurological condition.
Responding last month to an AHA letter, the Centers for Medicare & Medicaid Services said it will continue to remain flexible in its approach to surveys if a hospital experiences a COVID-19 surge.
The Food and Drug Administration July 2 authorized for emergency use one more batch of drug substance for the Janssen (Johnson & Johnson) COVID-19 vaccine at an Emergent BioSolutions facility in Baltimore.
The Food and Drug Administration revoked its emergency use authorizations for all disposable respirators lacking National Institute of Occupational Safety and Health approval, and for decontamination and bioburden reduction systems used to extend the use of disposable respirators.
Letter to OSHA requesting a six-month delay of its compliance dates for the recently announced COVID-19 Health Care Emergency Temporary Standard, thus giving hospitals and health systems ample time to implement the policy鈥檚 many new requirements.