[Federal Register Volume 73, Number 208 (Monday, October 27, 2008)]
[Notices]
[Page 63715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25586]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


Intrapartum Electronic Fetal Monitoring With Computer Assisted 
Diagnosis Workshop--Exploring Methods of Evaluation

AGENCY: Food and Drug Administration, HHS

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Intrapartum Electronic Fetal Monitoring (EFM) With 
Computer Assisted Diagnosis (CAD)--Exploring Methods of Evaluation.'' 
The objectives of this workshop are to gather ideas on how to identify 
and differentiate categories of EFM/CAD devices and the corresponding 
levels of evidence needed to validate these devices. Workshop 
participants will also discuss how currently available databases might 
be used to verify/validate intrapartum EFM/CAD algorithms.
    Date and Time: The workshop will be held on November 10, 2008, from 
8 a.m. to 5 p.m. Registrations will be accepted through October 31, 
2008. Participants are encouraged to arrive early to ensure time for 
parking, security screening, and registration before the meeting. 
Security screening will begin at 7 a.m. and registration will begin at 
7:30 a.m. See Registration Information section of this document for 
registration details.
    Location: The workshop will be held at the Food & Drug 
Administration White Oak Campus, conference room G-2047, 10903 New 
Hampshire Ave., Silver Spring, MD 20993.
    FDA will make every effort to accommodate persons with physical 
disabilities or special needs. If you require special accommodations 
due to a disability, please notify one of the contacts listed in this 
document (see Contact) at least 7 days in advance of the workshop.
    Contact: Sharon Andrews, Center for Devices and Radiological Health 
(HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-4148, FAX: 240-276-4156, 
[email protected]; or
    Elaine Blyskun, Center for Devices and Radiological Health (HFZ-
470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 240-276-4100, FAX: 240-276-4156, [email protected].
    Registration Information: Registration may be completed online at 
the following Web site: http://www.blsmeetings.net/1368-2. There is no 
registration fee for this workshop; however, all participants must 
submit a registration form. Space is limited, so please register as 
soon as possible to reserve a space. Registrations will be accepted 
through (see Dates). Persons without Internet access may contact 
Syreeta Tate-Jones at 301-577-0244, ext. 49 by October 31, 2008, to 
register.
    Agenda: The workshop will begin with a morning session to provide a 
clinical and regulatory overview of intrapartum fetal monitors. 
Presentation topics will address fetal monitoring in general, the 
relationship between technology and clinical decisionmaking, the 
current state of EFM/CAD development, and evaluation/validation methods 
that may be applied to new EFM/CAD systems. In the afternoon, attendees 
will break into two discussion groups: (1) EFM/CAD technological 
development and validation and (2) the practicality of using existing 
databases to test new EFM/CAD algorithms. The workshop will conclude 
with an overview of the break-out discussions and identification of 
research gaps and opportunities in the field.

    Dated: October 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25586 Filed 10-24-08; 8:45 am]
BILLING CODE 4160-01-S