The Food and Drug Administration (FDA) is announcing a public Workshop on “Device Improvements for Pediatric X-ray Imaging.” The main purpose of the workshop is to discuss the draft guidance “Pediatric Information for X-ray Imaging Device Premarket Notifications.” This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy devices. The guidance document was released in draft form for public comment on May 10, 2012. A Notice was published in the Federal Register on this same date for an open comment period for the guidance document that runs through September 6, 2012. In addition to soliciting public feedback on the draft guidance, the FDA has organized this meeting to help identify issues relevant to radiation safety in pediatric x-ray imaging that may benefit from standards development or further research.
- Date, Time and Location
- Federal Register Notice [Not Yet Available]
- Background
- Agenda
- Transcripts
- Public Comment
- Registration
- Contact Us
FDA Campus Information
This meeting will also be webcast. Persons interested in viewing the webcast must register online by July 9, 2012. Early registration is recommended because webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after July 12, 2012. If you have never attended a Connect Pro event before, test your connection. Also available is a quick overview of the Connect Pro program. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)
Federal Register Notice
The Food and Drug Administration is announcing a public meeting to discuss the draft guidance “Pediatric Information for X-ray Imaging Device Premarket Notifications.”
- Federal Register Notice [Not Yet Available]
Press Release: FDA proposal aims to help reduce unnecessary radiation exposure for pediatric patients
Draft Guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications
- Notification of Availability of draft guidance [Not Yet Available]
Pediatric X-ray Imaging Webpage: Provides information on the benefits and risks of imaging using ionizing radiation, recommendations for parents and health care providers to help reduce exposure to unnecessary radiation, and information for manufacturers of x-ray imaging devices.
Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
Agenda
Transcripts
As soon as a transcript is available, it will be accessible at: http://www.regulations.gov.
Public Comment
Regardless of attendance at the public meeting, any person may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 http://www.regulations.gov. It is only necessary to send one set of comments. Comments are to be identified with the docket number FDA-2012-N-0385. Received comments may be seen in the Division of Dockets Management between 9am and 4pm, Monday through Friday. To ensure consideration, all comments must be received by September 6, 2012.
- Notification of Availability of draft guidance [Not Yet Available]
Agenda
Transcripts
As soon as a transcript is available, it will be accessible at: http://www.regulations.gov.
Public Comment
Regardless of attendance at the public meeting, any person may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 http://www.regulations.gov. It is only necessary to send one set of comments. Comments are to be identified with the docket number FDA-2012-N-0385. Received comments may be seen in the Division of Dockets Management between 9am and 4pm, Monday through Friday. To ensure consideration, all comments must be received by September 6, 2012.