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FDA releases transition plans for medical device enforcement, authorization after COVID-19 public health emergency
The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations established during the COVID-19 public health emergency to normal operations.
FDA to wind down over 40 COVID-19 public health emergency policies
The Food and Drug Administration will end 22 COVID-19-related policies when the public health emergency ends May 11 and allow 22 to continue for 180 days, including temporary policies for outsourcing facilities compounding certain drugs for hospitalized patients and non-standard personal protective equipment practices for sterile compounders not registered as outsourcing facilities, the agency announced.
CMS summarizes the status of certain COVID-19 flexibilities after May 11
The Centers for Medicare & Medicaid Services yesterday released a fact sheet summarizing the status of public and private coverage for COVID-19 vaccines, testing, and treatments and certain blanket waivers for health care providers once the public health emergency ends on May 11.
COVID vaccines added to 2023 vaccine schedules
The Centers for Disease Control and Prevention has added COVID-19 vaccines to the U.S. 2023 immunization schedules for adults and children.
Survey finds information can raise COVID-19 booster coverage
In an online survey last November of 1,200 U.S. adults previously vaccinated against COVID-19, 62% had not yet received a bivalent booster dose, most often because they did not know they were eligible or the booster was available, or believed they were immune against infection.
AHRMM Novel Coronavirus (COVID-19) Update
Resources
AHRMM is keeping members and the public up to date on the latest Novel Coronavirus (COVID-19) developments with links to guidance from AHA, CDC, and other federal, state and local partners to make sure you have the most up-to-date information.
White House announces COVID-19 booster campaign
The Department of Health and Human Services will launch a national advertising campaign and tour to encourage families to get the updated Pfizer or Moderna COVID-19 vaccine booster.
CMS reinstates enforcement discretion under CLIA for certain SARS-CoV-2 tests
During the COVID-19 public health emergency, CMS will continue to exercise enforcement discretion under the Clinical Laboratory Improvement Amendments to allow providers to test asymptomatic individuals using certain point-of-care SARS-CoV-2 tests authorized for symptomatic individuals, CMS announced.
CDC updates COVID-19 infection control guidance for health care settings
The Centers for Disease Control and Prevention Friday updated its COVID-19 infection control guidance for U.S. health care settings based on current information. The guidance updates the circumstances when source control (respirator and face mask use) and universal personal protective equipment are recommended, and no longer uses vaccination status to inform source control, screening testing or post-exposure recommendations.
CDC: Masks still required in health care settings
The Centers for Disease Control and Prevention emphasized that its new masking recommendations for people fully vaccinated against COVID-19 do not apply to health care settings.