[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27875-27877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11170]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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).
SUPPLEMENTARY INFORMATION:
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
hemorrhage.
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]
BILLING CODE 4160-01-P