News | Pediatric Imaging | December 21, 2017

Document recommends special protocols and instructions for use on pediatric patients for new devices and modifications requiring submission of a new 510(k) application

FDA Issues Final Guidance on Pediatric X-ray Imaging Device Notifications

December 21, 2017 — The U.S. Food and Drug Administration (FDA) published a final guidance document entitled “Pediatric Information for X-ray Imaging Device Premarket Notifications,” encouraging manufacturers to consider child safety when designing X-ray imaging devices. In the guidance, which applies to new devices and modifications requiring the submission of a new 510(k), the FDA recommends manufacturers design these devices with protocols and instructions that address use on pediatric patients. It encourages the inclusion of pediatric indications and provides recommendations for labeling and instructions for use for X-ray imaging devices likely to be used on children.

This guidance reflects insights from the FDA’s partnerships with experts across the imaging and pediatric communities. It offers a balanced approach, which includes advice for imaging professionals to ensure pediatric patients receive the imaging exams they need without exposure to unnecessary radiation. The FDA believes new X-ray imaging devices should include clear and easily accessible information for imaging professionals on dose mitigation and management techniques, and instructions for imaging patients of all sizes.

The FDA will host a webinar “CDRH Final Guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications” on Jan. 9, 2018, for manufacturers and others interested in learning more about this guidance.  More information about the webinar is available at http://www.fda.gov/cdrhwebinar.

For additional information on the special challenges with imaging children, please visit the FDA’s Pediatric X-ray Imaging website. Other helpful sites include the American Association of Physicists in Medicine, the American College of Radiology, Image Gently Alliance and the World Health Organization.

For more information: www.fda.gov

Related Content

News | Digital Radiography (DR)

June 22, 2022 — Canadian manufacturer KA Imaging unveiled a new brand identity for its patented dual-energy technology ...

Time June 22, 2022
arrow
News | Radiology Imaging

June 21, 2022 — After less than two years of data collection and processing, the Radiological Society of North America ...

Time June 21, 2022
arrow
Feature | Digital Radiography (DR) | By ResearchAndMarkets

The "Mobile Imaging Services - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's ...

Time June 09, 2022
arrow
News | Digital Radiography (DR)

June 8, 2022 — MinXray continues to enhance the diagnostic capabilities of its digital radiography systems with the ...

Time June 08, 2022
arrow
News | X-Ray

June 2, 2022 — As healthcare industries begin to require International Organization for Standardization (ISO) ...

Time June 02, 2022
arrow
Feature | Radiology Business | By Melinda Taschetta-Millane

Here is what you and your colleagues found to be most interesting in the field of medical imaging during the month of ...

Time June 01, 2022
arrow
News | Artificial Intelligence

May 25, 2022 — A new method that combines imaging information with artificial intelligence (AI) can diagnose ...

Time May 25, 2022
arrow
News | Contrast Media

May 19 2022 — Recent disruptions in a pharmaceutical supply chain have impacted the global availability of GE Healthcare ...

Time May 19, 2022
arrow
News | Radiology Imaging

May 5, 2022 — Significant imaging findings (cancer, infection, pseudoaneurysm, fracture, bowel perforation) can occur in ...

Time May 05, 2022
arrow
Feature | Digital Radiography (DR) | By Melinda Taschetta-Millane

The COVID-19 pandemic turned the spotlight on diagnostic imaging by demanding a need for high-speed workflow and ...

Time May 03, 2022
arrow
Subscribe Now