[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Pages 20666-20667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07923]



Food and Drug Administration

[Docket No. FDA-2013-N-0345]

Food and Drug Administration/National Institutes of Health/
National Science Foundation Public Workshop on Computer Methods for 
Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing its fifth 
public workshop on Computer Methods for Medical Devices entitled ``FDA/
NIH/NSF Workshop on Computer Models and Validation for Medical 
Devices.'' The purpose of the workshop is to present, discuss, and 
receive input on an FDA library of models and data relevant to medical 
devices (day 1) and present, discuss, and receive input on a strategy 
to assess the credibility of computer models used to evaluate medical 
devices (day 2).

DATES: Dates and Times: The workshop will be held on June 11 and 12, 
2013, from 8:30 a.m. to 5:30 p.m.
    Location: The public workshop will be held at FDA's 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 Building 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: Donna Lochner, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
62, Rm. 3220, Silver Spring, MD 20993, 301-796-6309, 
Donna.Lochner@fda.hhs.gov; or Tina M. Morrison, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1272, Silver Spring, MD 20993, 301-796-6310, 
    Registration: Registration is free and will be on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by 4 p.m. on May 31, 2013. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permit, onsite registration on the day 
of the public workshop will be provided beginning at 8 a.m.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
Select this public workshop from the posted events list. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, mailing address, email address, and telephone number. 
Those without Internet access should contact Susan Monahan to register 
(301-796-5661 or Susan.Monahan@fda.hhs.gov). Registrants will receive 
confirmation after they have been accepted. You will be notified if you 
are on a waiting list.
    If you need special accommodations due to a disability, please 
contact Susan Monahan (Susan.Monahan@fda.hhs.gov or 301-796-5661) no 
later than May 28, 2013.
    Streaming Webcast of the Public Workshop: This workshop will also 
be available via Webcast. Persons interested in viewing the Webcast 
must register online by 4 p.m. on May 31, 2013. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to

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register all participants, but to view using one connection per 
location. Webcast participants will be sent technical system 
requirements after registration and connection access information after 
June 4, 2013. If you have never attended a Connect Pro event before, 
test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro 
program, visit http://www.adobe.com/go/connectpro_overview. (FDA has 
verified the Web site addresses in this document, but FDA is not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)
    Comments: FDA is holding this public workshop to obtain information 
on the topics identified in Section II of this document. In order to 
permit the widest possible opportunity to obtain public comment, FDA is 
soliciting either electronic or written comments on all aspects of the 
public workshop topics. The deadline for submitting comments related to 
this public workshop is July 10, 2013.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments to http://www.regulations.gov or 
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. Please 
identify comments with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.


I. Background

    The Center for Devices and Radiological Health (CDRH) believes that 
computer modeling and simulation (M&S) has the potential to 
substantially augment traditional models used to evaluate medical 
devices; i.e., animal, bench, and human models, and to accelerate and 
streamline the total product life cycle of a medical device. The use of 
computer models to simulate multiple use conditions and to visualize 
and display complex processes and data can revolutionize the way 
medical outcomes and medical devices are understood. Nonproprietary 
computer models could benchmark device performance, yet lack of access 
to biomedical data to construct the models and rigorous methods to 
validate the models limit their credibility and use. Before substantial 
advances in the use of M&S for regulatory decision making can be 
attained, a strategy and consistent framework to assess the credibility 
of M&S is needed. Moreover, to foster good science for M&S in the 
medical device community, CDRH needs to leverage the expertise in 
industry and academia to develop a strategy to scientifically assess 
the credibility of M&S and to develop a resource to publicize 
biomedical data, models and their validation for regulatory use.

II. Topics

    Historically, M&S have been used as development and design 
optimization tools, rather than methods by which performance of final 
devices can be demonstrated. Further, modeling studies that are 
submitted to the Agency are supplemental and complement animal, bench 
and human testing provided in:
     Investigational Device Exemptions (investigational 
     510(k) notifications (class II devices), and
     Pre-Market Approval applications (class III devices).

Some of the challenges with the current uses of M&S are:
     Reports typically lack sufficient details for adequate 
assessment because there are no reporting standards for computational 
     Lack of sensitivity and uncertainty analyses for crucial 
input parameters, such as geometry, physical properties, boundary 
     Lack of adequate validation to support the use of the 
computational model, and
     Lack of complete understanding of physiological loads and 
variations in patient populations.
    Adequate verification and validation (V&V) are necessary in order 
to foster confidence and wider acceptance of M&S for use in medical 
device evaluation. Therefore, CDRH, in collaboration with the American 
Society of Mechanical Engineers, has been drafting a guide on the 
``Verification and Validation of Computational Modeling for Medical 
Devices.'' The strategy is meant to create a framework for determining 
the risk associated with using a computational model in a specific 
context of use (COU) to inform decision making and for determining 
``how much'' V&V is necessary to support the model for its COU. The two 
main components of this strategy are the Risk Assessment Matrix and the 
Credibility Assessment Matrix. Both of these tools will be presented 
and discussed at the workshop. Note that these tools are still in DRAFT 
    The workshop will also describe and discuss FDA's efforts to create 
a resource or Library of biomedical data and models that can be used in 
regulatory applications. Key features and questions related to 
development of the Library and curation of data and models for the 
Library will be discussed. The goal of the FDA/NIH/NSF Workshop on 
Computer Modeling and Validation for Medical Devices is to discuss and 
receive input on these tools to enhance their utility in the community.

    Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07923 Filed 4-4-13; 8:45 am]