HHS Ends COVID-19 Emergency Declarations for Drugs and Devices
HHS said many products have since won traditional FDA approval or clearance, and the emergency liability shields will phase out over 180 days to 1 year.
- Health Secretary Robert F. Kennedy, Jr is ending emergency declarations for COVID-19 vaccines, treatments, and medical devices, determining that circumstances justifying emergency use no longer exist.
- First issued in 2020 to "enable rapid access to medical products during the pandemic," these declarations provided liability protections; Health Secretary Xavier Becerra previously extended them through 2029.
- Specifically, declarations for medical devices will end in 180 days, or until Dec. 26, 2026, while those for drugs and biological products will terminate in 1 year effective June 29, 2027. The FDA is working with manufacturers on seeking traditional approval.
- "By ending these COVID-19 emergency use authorization declarations, we're reinforcing public confidence that emergency authorities are temporary and targeted," Kennedy said. Americans deserve a transparent, accountable regulatory system rooted in the rule of law.
- Officials plan to notify Congress of the development, the Department of Health and Human Services said. The FDA will continue working with manufacturers to help products seek traditional regulatory pathways for approval, clearance, or licensure.
20 Articles
20 Articles
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RFK Jr. Announces He's Ending Emergency Liability Protection For...
Health Secretary Robert F. Kennedy Jr. is ending emergency declarations for COVID-19 vaccines, treatments, and medical devices, after determining that the circumstances that resulted in the declarations are no longer in place. The health secretary in office in early 2020 issued emergency declarations, providing liability protections for companies that made products for COVID-19 and enabling regulators to issue emergency authorizations, which hav…
Kennedy Begins Year-Long Wind-Down Of COVID-19 Emergency Use Authorization Declarations
This post was published by Jon Fleetwood. Support him by subscribing at Substack and following at Instagram / X / Facebook. Today, the U.S. Department of Health and Human Services (HHS) announced that Secretary Robert F. Kennedy, Jr. has “signed determinations terminating the COVID-19 Emergency Use Authorization (EUA) declarations for drugs and biological products and for medical devices, concluding that the circumstances that justified these e…
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