Skip to main content

Advertising Disclaimer »

Main menu

  • Journals
    • Pediatrics
    • Hospital Pediatrics
    • Pediatrics in Review
    • NeoReviews
    • AAP Grand Rounds
    • AAP News
  • AAP Policy
    • Topic/Program Collections
    • Policy
  • Pediatric Collections
    • COVID-19
    • Racism and Its Effect on Pediatric Health
    • More Collections...
  • Multimedia
    • Video Abstracts
    • Pediatrics On Call Podcast
  • Alerts
    • Table of Contents
    • Insights
  • AAP Career Center
  • Subscribe
  • Other Publications
    • American Academy of Pediatrics

User menu

  • Log in
  • My Cart

Search

  • Advanced search
American Academy of Pediatrics

AAP Gateway

Advanced Search

AAP Logo

  • Log in
  • My Cart
  • Journals
    • Pediatrics
    • Hospital Pediatrics
    • Pediatrics in Review
    • NeoReviews
    • AAP Grand Rounds
    • AAP News
  • AAP Policy
    • Topic/Program Collections
    • Policy
  • Pediatric Collections
    • COVID-19
    • Racism and Its Effect on Pediatric Health
    • More Collections...
  • Multimedia
    • Video Abstracts
    • Pediatrics On Call Podcast
  • Alerts
    • Table of Contents
    • Insights
  • AAP Career Center
  • Subscribe

EUAs address medical device needs of pediatric patients during pandemic

from the Food and Drug Administration’s Center for Devices and Radiological Health, Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
January 19, 2021
  • FDA Update

During the COVID-19 pandemic, the Food and Drug Administration (FDA) has used emergency use authorizations (EUAs) to help make certain medical products available to patients when there are no adequate, approved and available alternatives. While clinicians may be aware of EUAs issued for drug and biological therapeutics, EUAs also have been issued for diagnostic and therapeutic devices.

As of December 2020, the FDA had issued approximately 300 EUAs for COVID-19 molecular, antigen and serology tests. EUAs for COVID-19 tests generally have not been limited to a specific age range.

The FDA also has issued “umbrella” EUAs for ventilators, surgical masks and respirators to help increase the availability of these devices. More than a dozen ventilators are authorized for use in pediatric patients from birth through 21 years.

With rising hospitalizations due to COVID-19, other routinely used medical devices may become scarce for hospitalized patients, including pediatric patients.

“We should not forget the needs of children with respect to critically needed medical devices during the COVID-19 pandemic,” said Joy Samuels-Reid, M.D., pediatric medical officer at the FDA’s Center for Devices and Radiological Health.

The FDA has received EUA requests for COVID-related medical devices, including infusion pump systems, continuous positive airway pressure machines, airway clearance devices and anesthesia gas machines. The FDA supports sponsors seeking to ensure these devices are programmed to meet the specific needs of pediatric patients. For example, the FDA issued an EUA for a device that provides continuous renal replacement therapy and can be used in patients weighing 8 to 20 kilograms with lower blood volume or patients who have acute renal failure, fluid overload or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment.

The FDA continues to stress the importance of not losing sight of pediatric patients’ needs during the COVID-19 pandemic.

Resources
  • Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
  • In Vitro Diagnostics EUAs
  • Emergency Use Authorization for Prismaflex HF20 Set
  • Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff
  • Additional FDA Update columns
Copyright © 2021 American Academy of Pediatrics

Advertising Disclaimer »

Download PDF
Email News Article

Thank you for your interest in spreading the word on American Academy of Pediatrics.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
EUAs address medical device needs of pediatric patients during pandemic
(Your Name) has sent you a message from American Academy of Pediatrics
(Your Name) thought you would like to see the American Academy of Pediatrics web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Share
EUAs address medical device needs of pediatric patients during pandemic
from the Food and Drug Administration’s Center for Devices and Radiological Health, Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
January 19, 2021
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One
  • Digital Edition Current Issue
  • Latest Daily News
  • Archives
  • Collections
  • Columns
  • Advertising
  • Subscribe to AAP News Magazine
  • Terms of Use
  • Privacy Statement
  • FAQ
  • Contact Us
  • 2021 AAP Journals Catalog
  • Pediatrics
  • Pediatrics in Review
  • Hospital Pediatrics
  • NeoReviews
  • AAP Grand Rounds
  • AAP Career Center
  • shopAAP
  • AAP.org
  • AAP News
  • Visit AAP News on Facebook
  • Follow AAP News on Twitter
American Academy of Pediatrics

© 2021 American Academy of Pediatrics