Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

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Published

October 5, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Radiological Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

Full Text

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<title>Federal Register, Volume 88 Issue 192 (Thursday, October 5, 2023)</title>
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[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Page 69207]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22106]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0008]


Radiological Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Radiological Devices Panel of 
the Medical Devices Advisory Committee. The general function of the 
committee is to provide advice and recommendations to the Agency on 
FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will take place virtually on November 7, 2023, from 
9 a.m. to 12:15 p.m. eastern time.

ADDRESSES: All meeting participants will be heard, viewed, captioned, 
and recorded for this advisory committee meeting via an online 
teleconferencing and/or video conferencing platform. Answers to 
commonly asked questions including information regarding special 
accommodations due to a disability may be accessed at: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.

FOR FURTHER INFORMATION CONTACT: Jarrod Collier, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, 
<a href="/cdn-cgi/l/email-protection#1f557e6d6d707b315c707373767a6d5f797b7e3177776c31787069"><span class="__cf_email__" data-cfemail="a1ebc0d3d3cec58fe2cecdcdc8c4d3e1c7c5c08fc9c9d28fc6ced7">[email&#160;protected]</span></a>, 240-672-5763, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC 
area). A notice in the Federal Register about last-minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's website at <a href="https://www.fda.gov/AdvisoryCommittees/default">https://www.fda.gov/AdvisoryCommittees/default</a>.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before the 
meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. On November 
7, 2023, the committee will discuss and make recommendations on the 
classification of blood irradiator devices for the prevention of 
metastasis, which are currently unclassified pre-amendments devices, to 
class III (general controls and premarket approval).
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available on FDA's website at 
the time of the advisory committee meeting, and the background material 
will be posted on FDA's website after the meeting. Background material 
and the link to the online teleconference meeting room will be 
available at <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. Scroll down and select the appropriate advisory committee 
meeting link. The meeting will include slide presentations with audio 
components to allow the presentation of materials in a manner that most 
closely resembles an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
October 25, 2023. Oral presentations from the public will be scheduled 
on November 7, 2023, between approximately 9:20 a.m. and 10:20 a.m. 
eastern time. Those individuals interested in making formal oral 
presentations should notify the contact person and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before October 17, 2023. Time allotted for each presentation may 
be limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by October 
18, 2023.
    For press inquiries, please contact the Office of Media Affairs at 
<a href="/cdn-cgi/l/email-protection#4c2a282d23212d0c2a282d6224243f622b233a"><span class="__cf_email__" data-cfemail="9cfaf8fdf3f1fddcfaf8fdb2f4f4efb2fbf3ea">[email&#160;protected]</span></a> or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Ann Marie Williams at <a href="/cdn-cgi/l/email-protection#0f4e6161626e7d666a2178666363666e627c4f696b6e2167677c21686079"><span class="__cf_email__" data-cfemail="7e3f1010131f0c171b5009171212171f130d3e181a1f5016160d50191108">[email&#160;protected]</span></a> or 240-507-
6496 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22106 Filed 10-4-23; 8:45 am]
BILLING CODE 4164-01-P


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