[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Pages 27875-27877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11170]



Food and Drug Administration

[Docket No. FDA-2014-N-0531]

Hemostatic Medical Devices for Trauma Use; Public Workshop; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.


    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Hemostatic Medical Devices for Trauma Use.'' 
FDA is holding this public workshop to obtain information on the 
current challenges and opportunities related to hemostatic medical 
devices for use in emergency situations. The goals of the workshop are 
to discuss factors that contribute to hemostatic medical device 
performance and reliability and types of studies used to assess 
bleeding and validate methods to evaluate the severity of bleeding, and 
to define regulatory pathways for novel products.
    Dates and Times: The public workshop will be held on September 3 
and 4, 2014, from 8 a.m. to 5 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. 1503A), Silver Spring, MD 20993. 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 Person: Allison Kumar, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5402, Silver Spring, MD 20993, 301-796-6369, 
[email protected].
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by August 22, 2014, at 4 p.m. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permits, onsite registration on the day 
of the meeting/public workshop will be provided beginning at 7 a.m.

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    If you need special accommodations due to a disability, please 
contact Susan Monahan, (email: [email protected] or phone: 301-
796-5661) no later than August 20, 2014.
    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 meeting/public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, affiliation, email, and telephone number. Those 
without Internet access should contact Allison Kumar to register (see 
Contact Person). Registrants will receive confirmation after they have 
been accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by Wednesday, August 22, 2014. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after August 26, 2014. 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.)
    Requests for Protocols: In advance of the public workshop, CDRH 
would like to invite interested stakeholders to submit protocols that 
describe procedures to evaluate issues (e.g., design, validation, 
conduct, and analysis) related to the adequacy of studies pertaining to 
bench testing, animal testing, bleeding severity, human factors, and 
clinical data collection for hemostatic products. Of particular 
interest to the Agency are methods for assessing high-risk products 
used in non-compressible wound hemorrhage.
    The intention of collecting these protocols is for the Agency to 
review the submissions and determine viable solutions and paradigms for 
assessing the safety and effectiveness of hemostatic devices based on 
scientifically supported expert stakeholder opinions. The result of 
such a review will be incorporated into the public workshop for in-
depth discussion and consensus potentially leading to guidance from the 
Agency. Please note that while FDA safeguards study protocols and all 
proprietary information it receives, the protocols submitted in 
response to this request for protocols will be shared and potentially 
discussed publically. The deadline for submitting protocols for this 
public workshop is June 27, 2014. See the comments section for 
information on how to submit protocols. Please note that information 
submitted to the docket will be publically available.
    Comments: FDA is holding this public workshop to obtain information 
on the current challenges and opportunities related to hemostatic 
medical devices for use in emergency situations. 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 October 3, 2014.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document 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. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II of this document, please identify 
the question 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, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see Comments). 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. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).


I. Background

    There exists a large variety of hemostatic products on the market 
and in development that are being used for or are intended to be used 
to control potentially life-threatening bleeding in emergency 
situations when there may be no immediate medical facility nearby. Such 
devices may fit into various medical device regulatory categories such 
as the absorbable hemostatic agents (21 CFR 878.4490), externally 
applied vascular clamps (21 CFR 870.4450), various other class II 
devices, unclassified products (proposed for classification into class 
II), and those that may be proposed for other regulatory pathways, such 
as de novo petitions or PMA applications. There are currently a number 
of scientific and clinical challenges faced by industry and FDA that 
hamper the evaluation of such products. These include: The difficulty 
in measuring severity of bleeding in a consistent, reproducible and/or 
standardized manner, the lack of a bleeding severity scale (i.e., 
operationalizing the definition of bleeding severity); the 
translatability of animal models to the human clinical environment, the 
fact that different products present unique issues, and the challenge 
of evaluating innovative products when human clinical data are 
difficult to obtain.
    FDA is organizing a hemostatic medical devices public workshop 
focused on the current challenges and opportunities with hemostatic 
medical devices for use in emergency situations. The participants 
include a broad range of stakeholders that are responsible for the 
design, testing, manufacturing, regulation, and use of hemostatic 
devices. Specifically, the public workshop is intended to foster open 
constructive dialogue:
     On the challenges related to the design, development, 
evaluation, and use of hemostatic medical devices.
     To facilitate collaboration amongst stakeholders 
interested in hemostatic medical device development and use.
     To promote development of regulatory science tools for 
evaluating hemostatic medical devices.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not 
limited to, the following:

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    1. The current landscape of products used for emergency treatment 
of bleeding and the respective Centers, Divisions, and Branches within 
FDA involved in their review.
    2. Definitions of bleeding severity and methods for validating 
bleeding severity scales used in the evaluation of hemostatic devices.
    3. Pre-clinical studies, including animal studies, that can be used 
to collect data when clinical data are difficult to obtain. What value 
do these models provide (for the evaluation of hemostatic medical 
devices?) and what are their shortcomings?
    4. What options exist for obtaining clinical data for products used 
for emergency treatment of bleeding in both Civilian and Military 
settings, and which devices should be supported by clinical data?
    5. Products used for emergency treatment of bleeding are often used 
by a variety of end users and in a variety of high-stress situations; 
improper or unnecessary device use has the potential to cause serious 
harm. What human factors issues exist with use of these products and 
how should these issues be studied?
    6. Discussion of protocols used to study the topics, such as 
validation of bleeding severity, bench-top, animal, and human studies, 
and assessment of hemostatic devices used for non-compressible 
    These topics will be presented by experts in the associated area, 
followed by more indepth discussions of the given topics in smaller 
breakout sessions.

    Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11170 Filed 5-14-14; 8:45 am]