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 | Radiology Business

February 2, 2023 — Five additional imaging centers across Allegheny Health Network (AHN) have been recognized by the ...

Time February 02, 2023
arrow
News | Radiology Imaging

January 23, 2023 — Canon Medical Systems has released a new eBook featuring its new medical imaging roadshow. This new ...

Time January 23, 2023
arrow
News | Radiology Imaging

January 20, 2023 — Today, the U.S. Food and Drug Administration (FDA) published the final rule: Radiological Health ...

Time January 20, 2023
arrow
News | RSNA

January 18, 2023 — Artificial intelligence (AI) may help improve care for patients who show up at the hospital with ...

Time January 18, 2023
arrow
News | Radiology Business

January 5, 2023 — StreamlineMD has provided updates for 2023 Radiology and IR CPT coding, which may impact your practice ...

Time January 05, 2023
arrow
News | Digital Radiography (DR)

January 2, 2023 — Detection Technology, a global leader in X-ray detector solutions, announced X-ACE 16 HD (high ...

Time January 02, 2023
arrow
News | Digital Radiography (DR)

December 30, 2022 — Carestream Health announced new innovations in its long-length imaging digital radiography (DR) ...

Time December 30, 2022
arrow
News | X-Ray

December 30, 2022 — KA Imaging’s dual-energy technology (branded as SpectralDR) has been shown to improve reading ...

Time December 30, 2022
arrow
News | RSNA

December 26, 2022 — Konica Minolta Healthcare Americas, Inc., a leader in medical diagnostic imaging and healthcare ...

Time December 26, 2022
arrow
News | Pediatric Imaging

December 23, 2022 — Findings from an accepted manuscript published in ARRS’ American Journal of Roentgenology (AJR) have ...

Time December 23, 2022
arrow
Subscribe Now