09-19904. Methodologies for Post-Approval Studies of Medical Devices; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

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 Caños, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., WO66/Room 4120, Silver Spring, MD 20993, 240-796-6057, [e-mail] ; 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, [e-mail]

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 Caños (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.