[Federal Register Volume 75, Number 152 (Monday, August 9, 2010)]
[Pages 47819-47820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19530]



Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Workshop on Optimizing Clinical Trial Design for the Development 
of Pediatric Cardiovascular Devices

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.


    The Food and Drug Administration (FDA) and National Institutes of 
Health (NIH), with support from the American Academy of Pediatrics 
(AAP), the American College of Cardiology (ACC), and the Society for 
Cardiovascular Angiography and Interventions (SCAI) are announcing a 
public workshop entitled ``Optimizing Clinical Trial Design for the 
Development of Pediatric Cardiovascular Devices.'' The topic to be 
discussed is pediatric cardiovascular device development. The purpose 
of the public workshop is to solicit information from clinicians, 
academia, professional societies, other government agencies, and 
industry on various efficient and pragmatic clinical trial designs that 
are conducive to overcoming the challenges in developing devices for 
the pediatric cardiology market. The information gathered in this and 
future workshops will help to develop future guidance on optimal 
designs for pediatric cardiology device trials.
    Date and Time: The public workshop will be held on September 30, 
2010, from 8 a.m. to 5:30 p.m.
    Location: The public workshop will be held at Moscone Center, 747 
Howard St., San Francisco, CA 94103.
    Contact Person: Francesca Joseph, Office of Orphan Products 
Development, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, rm. 5277, Silver Spring, MD 20903, 301-796-6805, FAX: 301-
847-8621, e-mail: [email protected].
    Registration: Registration information will be posted on the 
Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.

[[Page 47820]]

    If you need special accommodations due to a disability, please 
contact Lynn Colegrove by phone 847-434-7820 at least 7 days in 
    Registration and seating will be on a first-come, first-served 
basis. A discussion preference will be afforded to clinical research 
investigators involved in pediatric clinical device trials, health care 
givers, and patient advocates. There is no registration fee to attend 
the public workshop. Early registration is recommended because seating 
is limited. There will be no onsite registration.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: In the medical device industry, rarely have 
devices been developed, evaluated, and approved specifically for 
treatment of children with congenital heart disease. The small, 
heterogeneous population, need for long-term followup, lack of market 
incentive, and misperceptions of regulatory requirements and costs are 
a few of the issues that make a standard randomized control trial 
difficult to conduct in pediatric cardiology. The goal of the workshop 
is to educate the medical device industry and pediatric clinical 
community about device development and regulatory approval processes, 
and to identify clinical trial designs that lend themselves to 
overcoming the challenges in pediatric cardiovascular device 
development. Subsequently making this information available to 
industry, the clinical community, and the public is imperative to 
furthering the development of pediatric cardiovascular devices and 
alleviating this critical unmet need. The marketing approval of more 
cardiovascular devices specifically designed and/or labeled for 
pediatric patients would have a significant impact on public health. 
Invited experts will address types of clinical trials with a particular 
focus on trial designs and statistical analysis methods, as well as 
alternative sources of clinical data, that can help to address the 
challenges in this particular patient population. After each section 
there will be an audience question and answer session and panel 
discussion allowing workshop participants to interact with the speakers 
and panelists. A concluding session will allow for additional 
    Background information on the public workshop, registration 
information, the agenda, information about lodging, and other relevant 
information will be posted, as it becomes available, on the Internet at 

    Dated: August 4, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for 
Devices and Radiological Health.
[FR Doc. 2010-19530 Filed 8-6-10; 8:45 am]