[Federal Register: October 27, 2008 (Volume 73, Number 208)]
[Notices]
[Page 63715]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc08-67]
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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,
sharon.andrews@fda.hhs.gov; 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, elaine.blyskun@fda.hhs.gov.
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