Medical Devices

Webinar - Pediatric Information for X-ray Imaging Device Premarket Notifications: Final Guidance - January 9, 2018

  

On November 27, 2017, the FDA released a final guidance encouraging manufacturers to consider radiation safety of pediatric populations in the design of X-ray imaging devices. The FDA recommends manufacturers include instructions and information for health care professionals about pediatric imaging features in their user manuals and other materials. With appropriate instructions, safety information, and a description of available pediatric-specific features, health care professionals can then make more informed decisions about use of the device on pediatric patients.

On Tuesday, January 9, 2018, the FDA hosted a webinar for industry to discuss and answer questions about this final guidance.

As always, we appreciate your feedback; following the conclusion of the webinar, please complete a short survey about your FDA CDRH webinar experience. The survey link will be provided at the conclusion of the webinar.

NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.

Target Audience: Industry

If you have any questions, please contact CDRH's Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.

Page Last Updated: 03/08/2018
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