80 FR 39441 - Acute Ischemic Stroke Medical Devices Trials Workshop; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 131 (July 9, 2015)

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Acute Ischemic Stroke Medical Device Trials Workshop''. Acute ischemic stroke medical devices are intended to remove blood clots from the cerebral neurovasculature by mechanical, laser, ultrasound, or a combination of technologies. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for acute ischemic stroke emerging technologies and help to speed development and approval of future submissions.

[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)]
[Notices]
[Pages 39441-39442]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16774]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Acute Ischemic Stroke Medical Devices Trials Workshop; Public 
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Acute Ischemic Stroke Medical 
Device Trials Workshop''. Acute ischemic stroke medical devices are 
intended to remove blood clots from the cerebral neurovasculature by 
mechanical, laser, ultrasound, or a combination of technologies. The 
purpose of this workshop is to obtain public input and feedback on 
scientific, clinical, and regulatory considerations associated with 
acute ischemic stroke medical devices. Ideas generated during this 
workshop may facilitate further development of guidance regarding the 
content of premarket submissions for acute ischemic stroke emerging 
technologies and help to speed development and approval of future 
submissions.

DATES: The public workshop will be held on October 6, 2015, from 1 p.m. 
to 5:30 p.m. Registration to attend the meeting must be received by 
September 25, 2015, at 4 p.m. See the SUPPLEMENTARY INFORMATION section 
for instructions on how to register for the public workshop. Submit 
either electronic or written comments by November 3, 2015.

ADDRESSES: The public workshop will be held at the Bethesda Pooks Hill 
Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814. Please visit the 
following Web site for parking and security information: http://www.marriott.com/hotels/maps/travel/wasbt-bethesda-marriott/.
    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. All comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Hilda Scharen, Center for Devices and 
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 3625, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6815, 
[email protected]; or Jamie Waterhouse, Project Manager, 
Neurointerventional and Neurosurgical Devices Branch, Division of 
Neurological and Physical Medicine Devices, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-3063, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Acute ischemic stroke medical devices are intended to remove blood 
clots from the cerebral neurovasculature. This may be achieved through 
a variety of mechanisms, such as mechanical, laser, ultrasound, or a 
combination of technologies. Acute ischemic stroke medical devices can 
present both important safety and effectiveness questions as well as 
study design and data analysis challenges.

II. Purpose and Scope of the Public Workshop

    The workshop seeks to involve industry and academia in addressing 
scientific, clinical, and regulatory considerations associated with 
acute ischemic stroke medical devices. By bringing together relevant 
stakeholders, which include scientists, patient advocates, clinicians, 
researchers, industry representatives, and regulators,

[[Page 39442]]

to this workshop, we hope to facilitate the improvement of this rapidly 
evolving product area.
    This workshop is aimed to address scientific, clinical, and 
regulatory considerations associated with acute ischemic stroke medical 
devices, including but not limited to, the following topic areas:
     Considerations for clinical study trial designs, patient 
populations, and patient selection methods, and
     Considerations for clinical study endpoints, e.g., 
clinically relevant outcome measures and related statistical analyses.

III. Attendance and Registration

    Registration is free and available on a first-come, first-served 
basis. Persons interested in attending this public workshop must 
register online by September 25, 2015, 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 public workshop 
will be provided beginning at 12 p.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, email: [email protected] or phone: 301-
796-5661 no later than September 25, 2015.
    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 Susan Monahan to register. 
Registrants will receive confirmation after they have been accepted. 
You will be notified if you are on a waiting list.

IV. Comments

    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 November 3, 2015.
    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 (see ADDRESSES). 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.

V. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may also be viewed 
at the Division of Dockets Management (see ADDRESSES). A transcript 
will 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 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).

    Dated: July 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16774 Filed 7-8-15; 8:45 am]
 BILLING CODE 4164-01-P