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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - Device Improvements for Pediatric X-ray Imaging, July 16, 2012

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 The main purpose of the workshop is to discuss the draft guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications."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 In addition to soliciting public feedback on the draft guidance, the FDA has organized this meeting to help identify issues relevant to radiation safety in pediatric x-ray imaging that may benefit from standards development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

This meeting will be held July 16, 2012. Registration will begin at 7:00am and the meeting will begin promptly at 8:00am at the following location:

FDA White Oak Campus (Building 31, Great Room)
10903 New Hampshire Avenue
Silver Spring, MD 20993

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The Food and Drug Administration is announcing a public meeting to discuss the draft guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications."

Background

The draft guidance and other pediatric dose reduction efforts are part of FDA's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. More information can be found here:

Agenda

Time Subject Speaker
8:00-8:15Structure of the Day and Logistics Moderator: CAPT Sean M. Boyd, MPH, USPHS ; FDA/CDRH/OCER, Deputy Director of the Division of Mammography Quality and Radiation Programs
8:15-9:30Session 1: FDA Introduction 
8:15-8:301. FDA's Regulation of X-ray Imaging DevicesMary S. Pastel, ScD; FDA/CDRH/OCER, Deputy Director for Technical and Radiological Initiatives
8:30-8:502. Medical Radiation Dose Reduction InitiativeCAPT Sean M. Boyd
8:50-9:303. FDA's Pediatric Dose Reduction EffortsThalia T. Mills, PhD; FDA/CDRH/OCER, Physicist
9:30-9:45Break  
9:45-10:45Session 2: Perspectives from Pediatric X-ray Imaging Users Representatives of the Alliance for Radiation Safety in Pediatric Imaging (ARSPI)
1. Introduction: Image Gently Comments to the FDA and Industry Regarding Modifications to Imaging Equipment for Use in ChildrenMarilyn J. Goske, MD, FAAP; Cincinnati Children's Hospital Medical Center
2. Digital RadiographySteven Don, MD; Mallinckrodt Institute of Radiology, Washington University School of Medicine
3. Modifications to Diagnostic FluoroscopyMarta Hernanz-Schulman, MD , FAAP, FACR; Vanderbilt University
4. Progress and Challenges in Computed Tomography for ChildrenDonald Frush, MD, FACR, FAAP; Duke Medical Center
5. Progress and Challenges in Dentomaxillofacial Imaging for ChildrenAlan G. Lurie, DDS, PhD; University of Connecticut School of Dental Medicine (also representing American Academy of Oral and Maxillofacial Radiology)
6. Response to FDA's: Pediatric Information for X-ray Imaging Device Premarket NotificationsKeith J. Strauss, MSc, FAAPM, FACR; Cincinnati Children's Hospital Medical Center
10:45-11:45Session 3: Industry perspectives Representatives of the Medical Imaging and Technology Alliance (MITA)
1. Opening RemarksGail Rodriguez, PhD; MITA
2. General Industry OverviewPaul Biggins; Toshiba America Medical Systems
3. Computed Radiography/Digital Radiography (CR/DR)Robert Uzenoff; FUJIFILM Medical Systems
4. Interventional X-ray EquipmentPhilip Malca; GE Healthcare
5. Computed Tomography (CT)John Jaeckle; GE Healthcare
11:45-12:45Lunch  
12:45-12:50Afternoon session: introduction CAPT Sean M. Boyd
12:50-2:00Session 4: Open public comment Registered speakers
1. AAP- Pediatric Information for X-ray Imaging Device Premarket NotificationsDorothy Bulas, MD, FAAP, FACR, FAIUM; Children's National Medical Center (representing American Academy of Pediatrics (AAP))
2. Device Improvements for Pediatric X-ray ImagingMark A. Fogel, MD, FACC, FAHA, FAAP; The Children's Hospital of Philadelphia (representing American College of Cardiology (ACC))
3. (Amifostine:WR2721) Diagnostic Radiology ApplicationDavid J. Grdina, PhD; The University of Chicago
4. Statement by the American Association of Physicists in Medicine (AAPM)Ralph P. Lieto, MSE; St. Joseph Mercy Hospital (representing AAPM)
5. Simple tools for assessing image quality and dose estimates on systems used with neonate patientsRobert L. Steinhauser, MS, MBA; Gammex, Inc
6. Why dental X-rays cannot be compared to chest X-raysCaroline Rodgers
7. Features key to pediatric CT scannerMahadevappa Mahesh , MS, PhD, FAAPM, FACR, FACMP, FSCCT; Johns Hopkins University School of Medicine
8. Progress and Challenges in the Education of Radiographers for ChildrenTracy Herrmann, MEd, RT(R); University of Cincinnati Blue Ash College (representing ARSPI and American Society of Radiologic Technologists (ASRT))
9. Progress and Challenges in the Education of Radiographers for ChildrenGreg Morrison, MA, RT(R), CNMT, CAE; ASRT (representing ARSPI and ASRT)
10. Progress and Challenges in Education for Physicians Who Perform Imaging in ChildrenMarilyn J. Goske, MD, FAAP; Cincinnati Children's Hospital Medical Center (representing ARSPI)
2:00-3:00Session 5: Lessons learned from device modification projects for pediatric imaging  
2:00-2:101. Prioritizing Device Improvements: Importance of Consensus Recommendations from End UsersDonald L. Miller, MD, FSIR, FACR; FDA/CDRH/OCER, Chief of the Diagnostic Devices Branch in the Division of Mammography Quality and Radiation Programs
2:10-2:252. Modifying/Configuring Imaging Equipment for Children: A Pediatric Medical Physicist's ExperienceKeith J. Strauss, MSc, FAAPM, FACR; Cincinnati Children's Hospital Medical Center
2:25-2:403. Manufacturer Collaboration with the User Community to Address Pediatric Dose IssuesTony Roder and John Jaeckle; GE Healthcare (representing MITA)
2:40-3:00Discussion 
3:00-3:15Break  
3:15-5:00

Roundtable discussion (includes Q&A from audience)

Participants:

1. Paul Biggins; Toshiba America Medical Systems (representing MITA)

2. Steven Don, MD; Mallinckrodt Institute of Radiology, Washington University School of Medicine (representing ARSPI)

3. Thomas Fearon, PhD; Children's National Medical Center

4. Mark A. Fogel, MD, FACC, FAHA, FAAP; The Children's Hospital of Philadelphia (representing ACC)

5. Donald Frush, MD, FACR, FAAP; Duke Medical Center (representing ARSPI)

6. Tracy Herrmann, MEd, RT(R); University of Cincinnati Blue Ash College (representing ARSPI and ASRT)

7. Ralph P. Lieto, MSE; St. Joseph Mercy Hospital (representing AAPM)

8. Alan G. Lurie, DDS, PhD; University of Connecticut School of Dental Medicine (representing AAOMR and ARSPI)

9. Thalia T. Mills, PhD; FDA/CDRH

10. Greg Morrison, MA, RT(R), CNMT, CAE; ASRT (representing ARSPI and ASRT)

5:00-5:15Closing remarks and adjournmentCAPT Sean M. Boyd

Transcripts

A transcript is available.

Webcast

An archived webcast for this event is available.

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 7, 2012.

Registration to Attend the Workshop

As of July 9, 2012, online registration is now closed.

However, there is still space available to attend the workshop in person or view the webcast. Please send inquiries about meeting attendance or webcast viewing to Cindy Garris at: phone: 301-796-5861, email: cynthia.garris@fda.hhs.gov.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

All meeting participants will be able to listen to all the presentations and roundtable discussion, as well as submit questions for the roundtable during the meeting.

Requests for Oral Presentations: This workshop includes a public comment session. If you wish to make an oral presentation during the open comment session, you must indicate this at the time of registration. You will be requested to indicate the topic(s) of your presentation. FDA requests that presentations focus on questions posed in the FR notice for the public meeting or any other comments on the draft guidance. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the public comment session. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants. Speakers will receive instructions on how to submit visuals, which must be submitted to FDA by July 9, 2012.

Requests to Participate in Roundtable Discussion: This workshop also includes a roundtable discussion. If you wish to participate in the roundtable discussion, you must indicate this at the time of registration. The number of roundtable participants will be limited, but all meeting participants will have the opportunity to view and submit questions to the roundtable. A request to be a participant does not guarantee a place in the roundtable discussion. Participants will be chosen to represent a broad variety of interest groups.

Contact Us

If you need special accommodations due to a disability, or additional information regarding registration, please contact Cindy Garris, Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, phone: 301-796-5861, email: cynthia.garris@fda.hhs.gov.