Document ID: FDA-2011-N-0002-0137
Agency: fda
Document Type: Notice
Title: Bridging the Idea Development Evaluation Assessment and Long-Term Initiative and Total Product Life Cycle Approaches for Evidence Development for Surgical Medical Devices and Procedures: Public Workshop
Posted Date: 2011-11-07T05:00Z

[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Pages 68769-68770]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28722]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Bridging the Idea Development Evaluation Assessment and Long-Term 
Initiative and Total Product Life Cycle Approaches for Evidence 
Development for Surgical Medical Devices and Procedures; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Bridging the IDEAL and TPLC Approaches for Evidence 
Development for Surgical Medical Devices and Procedures.'' The purpose 
of the public workshop is to provide a forum for discussion among FDA, 
governmental agencies, academia, physicians, and various stakeholders 
to further refine and advance the Idea Development Evaluation 
Assessment and Long-Term (IDEAL) initiative and Total Product Life 
Cycle (TPLC) frameworks related to evidence generation and evaluation 
for surgical devices and procedures.
    Date and Time: The meeting will be held on December 2, 2011, from 8 
a.m. to 5:30 p.m. Participants are encouraged to arrive early to ensure 
time for parking and security screening before the meeting. Submit 
electronic and written comments by January 6, 2012.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Bldg. 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Persons: Samantha Jacobs, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 4113, Silver Spring, MD 20993, (301) 796-6897, 
email: Samantha.jacobs@fda.hhs.gov; or Danica Marinac-Dabic, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4113, Silver Spring, MD 20993, (301) 
796-6689, email: danica.marinac-dabic@fda.hhs.gov.
    Registration: There is no fee to attend the public workshop, but 
attendees must register in advance. Registration will be on a first-
come, first-served basis. Persons interested in attending this workshop 
must register online at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ by November 25, 2011. Non-U.S. citizens are 
subject to additional security screening, and they should register as 
soon as possible. For those without Internet access, please call the 
contact person to register. Onsite registration is not available.
    If you need special accommodations due to a disability, please 
contact Susan Monahan at susan.monahan@fda.hhs.gov at least 7 days in 
advance.
    Comments: Regardless of attendance at the public workshop, 
interested persons may submit either electronic or written comments 
until January 6, 2012. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. It is no longer necessary to send two copies of mailed 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
topics as outlined in section III of this document, please identify the 
topic you are addressing. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION: 

I. Why are we holding this public workshop?

    The purpose of the public workshop is to facilitate discussion 
among FDA, governmental agencies, academia, clinicians, and the key 
stakeholders in the scientific community on issues related to evidence 
generation and evaluation for surgical devices and procedures. Based on 
complementary methodological frameworks of the IDEAL and TPLC 
initiatives, more comprehensive and applicable models and methodologies 
will be developed.

II. Who is the target audience for this public workshop? Who should 
attend this public workshop?

    This workshop is open to all interested parties. The target 
audience is comprised of professionals in the scientific community 
interested in advancing the infrastructure and methodology for 
evaluating surgical devices and procedures.

III. What are the topics we intend to address at the public workshop?

    We intend to discuss a large number of issues at the workshop, 
including, but not limited to, the following:
     The IDEAL and the FDA TPLC approach for evaluation of new 
medical devices, surgical operations, and invasive medical procedures;
     Unique study designs and reporting methods for evaluation 
of medical devices and surgeries;
     Innovative methodologies and scientific infrastructure to 
promote innovation;
     The role of registries and observational studies during 
device life cycle; and
     Integrating innovation, evaluation, and dissemination 
pathways for medical devices, surgical operations, and invasive medical 
procedures.

IV. 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.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will

[[Page 68770]]

be accessible at http://www.regulations.gov. It may be viewed at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be 
available in either hardcopy or on CD-ROM, after submission of a 
Freedom of Information request. Written requests are to be sent to the 
Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: November 1, 2011.
Leslie Kux,
 Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28722 Filed 11-4-11; 8:45 am]
BILLING CODE 4160-01-P