Document ID: FDA-2009-N-0664-0072
Agency: fda
Document Type: Notice
Title: Methodologies for Post-Approval Studies of Medical Devices; Public Workshop
Posted Date: 2009-08-19T04:00Z

[Federal Register: August 19, 2009 (Volume 74, Number 159)]
[Notices]               
[Page 41916]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19au09-73]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Methodologies for Post-Approval Studies of Medical Devices; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Methodologies for Post-Approval Studies of Medical 
Devices.'' The purpose of the workshop is to facilitate discussion 
among FDA, industry, academia, professional societies, clinical 
investigators and other interested parties on issues related to 
methodologies for post-approval studies of medical devices. The target 
audiences for this workshop are Epidemiologists, Statisticians, 
Clinicians and Regulatory Affairs Specialists.
    Dates and Times: The workshop will be held on September 9, 2009, 
from 9 a.m. to 5 p.m. and September 10, 2009, from 9 a.m. to 5 p.m. 
Participants are encouraged to arrive early to ensure time for parking 
and security screening before the meeting. Security screening will 
begin at 8 a.m., and registration will begin at 8:30 a.m. Please pre-
register for the workshop by following the instructions in this 
document.
    Location: The workshop will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Silver Spring, MD 20993.
    Contact Persons: Daniel Ca[ntilde]os, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., WO66/Room 4120, Silver Spring, MD 20993, 240-796-6057, 
daniel.canos@fda.hhs.gov ; or Ellen Pinnow, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., WO66/Room 4106, Silver Spring, MD 20993, 301-796-6066, 
ellen.pinnow@fda.hhs.gov
    Registration: To register for the conference please visit the 
following Web site: https://medsun2.S-3.net/FDAPASWkshpSep09. There is 
no fee to attend the workshop, but attendees must register in advance. 
The registration process will be handled by Social and Scientific 
Systems, which has extensive experience in planning, executing, and 
organizing educational meetings. Although the facility is spacious, 
registration will be on a first-come, first-served basis. In-person 
attendance is limited to 120 participants. You may also register to 
attend the meeting via webcast. Non-U.S. citizens are subject to 
additional security screening, and they should register as soon as 
possible. If you need special accommodations because of a disability, 
please contact Daniel Ca[ntilde]os (see Contact Persons) at least 7 
days before the public workshop.

SUPPLEMENTARY INFORMATION:

I. Why Are We Holding This Public Workshop?

    The purpose of the public workshop is to facilitate discussion 
among FDA and other interested parties on methodological issues related 
to Post-Approval Studies for medical devices.

II. What Are the Topics We Intend To Address at the Public Workshop?

    We hope to discuss a large number of issues at the workshop, 
including, but not limited to:
     Regulatory requirements for conducting Post-Approval 
Studies for medical devices;
     Using existing infrastructure (e.g., registries) to 
facilitate Post-Approval Studies;
     Using innovative study design strategies and advanced 
epidemiologic methods to enhance and facilitate Post-Approval Studies;
     Review important measurement considerations inherent to 
Post-Approval Studies;
     Clinical research organizations, industry, academia, and 
other clinical trial consultant's perspectives on all of the previous 
issues related to Post-Approval Study methodologies for medical 
devices.

III. Where Can I Find Out More About This Public Workshop?

    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 
http://www.fda.gov/cdrh/meetings.html.

    Dated: August 12, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. 09-19904 Filed 8-18-09; 8:45 am]

BILLING CODE 4160-01-S