[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