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 will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations by the Advisory Committee on Immunization Practices.
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial intelligence-enabled medical device performance in real-world applications. This includes approaches to detect, assess and mitigate performance…
The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following reports of device components detaching during procedures. The company was alerted to incidents resulting in one patient death and one injury…
The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore its neutral setting and allows it to move unexpectedly. The FDA said there has been one reported injury and no deaths related to the issue.…
COVID-19 infections are growing or likely growing in 45 states and not changing in five states, according to the latest data from the Centers for Disease Control and Prevention Aug. 8. Wastewater levels for COVID-19 have been classified as moderate nationwide, with the highest detected in the…
The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium. The FDA said the inadvertent administration of cefazolin following a recommended dosage of penicillin G potassium could pose serious and…
Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 27 announced in a post on X that the Centers for Disease Control and Prevention would no longer recommend the COVID-19 vaccine for healthy children and pregnant women.
The Centers for Disease Control and Prevention last week endorsed a recommendation from the Advisory Committee on Immunization Practices for people aged 65 and older along with individuals moderately or severely immunocompromised to receive a second dose of the 2024-2025 COVID-19 vaccine six months…
The Centers for Medicare & Medicaid Services Oct. 22 released final guidance detailing reporting requirements for the hospital respiratory data condition of participation.
The Food and Drug Administration Aug. 22 granted emergency use authorization for two new combined COVID-19 and influenza tests.