[Federal Register: December 20, 2005 (Volume 70, Number 243)]
[Notices]
[Page 75465-75466]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de05-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0485]
Regulatory Process for Pediatric Mechanical Circulatory Support
Devices (Ventricular Assist Devices)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public meeting: Regulatory Process for Pediatric Mechanical
Circulatory Support Devices (Ventricular Assist Devices). The topics of
discussion are the agency's activities regarding the regulation and
approval of circulatory support devices used for temporary support in
pediatric patients.
Date and Time: The public meeting will be held on January 20, 2006,
from 9 a.m. to 12 p.m. The agency is requiring registration by December
30, 2005.
Location: The public meeting will be held at the Center for Devices
and Radiological Health, rm. 20B, 9200 Corporate Blvd., Rockville, MD
20850.
Contact: Eric Chen, Center for Devices and Radiological Health
(HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 301-443-
8262, ext. 146, e-mail: eac@cdrh.fda.gov, or Michael Berman (HFZ-170),
12725 Twinbrook Pkwy., 301-827-4744, e-mail: mrb@cdrh.fda.gov. If you
need special accommodations due to a disability, please contact Eric
Chen, at least 7 days in advance of the meeting.
Registration: There is no fee to attend the workshop; however,
because space is limited, registration is required. Please submit
registration information (including name, title, firm name, address, e-
mail address, telephone number, and fax number) by December 30, 2005
(see Contact). Background information for the workshop will be
[[Page 75466]]
available to the public on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/meetings/012006workshop/index.html
.
SUPPLEMENTARY INFORMATION: This workshop helps fulfill the Department
of Health and Human Services' and FDA's important mission to protect
the public health by providing the medical device community with
guidance on the approval process for mechanical circulatory support
devices (ventricular assist devices) used in pediatric patients in need
of temporary support (left side, right side, or both sides). During the
public workshop, FDA will present information regarding the approval
process for these devices. Specifically, FDA will address applications
for premarket approval, humanitarian use designations, humanitarian
device exemptions, and investigational device exemptions. FDA will also
present information regarding preclinical engineering qualification of
pediatric mechanical circulatory support devices and invited experts
will discuss medical and surgical topics. Following each presentation,
and at the close of the meeting, FDA will conduct a question and answer
session with the participating audience. After the workshop,
presentations can be accessed by the public on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/meetings/012006workshop/index.html
.
This workshop helps to implement the objectives of section 406 of
the FDA Modernization Act (21 U.S.C. 393) and the FDA Plan for
Statutory Compliance, which include working more closely with
stakeholders and ensuring access to needed scientific and technical
expertise. The workshop also furthers the goals of the Small Business
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing
outreach activities by Government agencies directed to small
businesses.
Dated: December 12, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-24271 Filed 12-19-05; 8:45 am]
BILLING CODE 4160-01-S