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  4. May 23, 2024: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement - 05/23/2024
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Advisory Committee Meeting | Virtual

Event Title
May 23, 2024: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement
May 23, 2024

Date:
May 23, 2024
Time:
9:30 AM - 5:30 PM ET

What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

Update: May 9, 2024

Please be advised that James Swink will be the acting DFO for the May 23, 2024 Molecular and Clinical Genetics meeting. You can reach James Swink via email at James.Swink@fda.hhs.gov.

Webcast Information

YouTube:
https://youtu.be/UBWk4edINzE

Center Date Time Location
CDRH May 23, 2024 9:30 a.m. - 5:30 p.m. All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 

[Docket No. FDA-2024-N-0008] 

Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting--Shield

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Molecular and Clinical Genetics 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 May 23, 2024, from 9:30 a.m. to 5:30 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 about FDA advisory committee meetings, including information regarding special accommodations due to a disability may be accessed at:  https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.  

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, Jarrod.Collier@fda.hhs.gov, 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 https://www.fda.gov/AdvisoryCommittees/default.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 May 23, 2024, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Shield test by Guardant Health, Inc.  The proposed indication for use statement is as follows:  The Shield test is a qualitative in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit.  Shield is intended for colorectal cancer screening in individuals at average risk of the disease, age 45 years or older.  Patients with an “Abnormal Signal Detected” may have colorectal cancer or advanced adenomas and should be referred for colonoscopy evaluation.  Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.  The test is performed at Guardant Health, Inc.

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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.  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 May 10, 2024.  Oral presentations from the public will be scheduled on May 23, 2024, between approximately 1:45 p.m. and 2:45 p.m. Eastern Time.  Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT).  The notification should include 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 May 7, 2024.  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 May 8, 2024.  

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov 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 Artair Mallett at Artair.Mallett@fda.hhs.gov or 301-796-9638 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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. 1001 et seq.).  This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform.  This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers.  The conditions for issuance of a waiver under 21 CFR 10.19 are met.  

Dated:  April 17, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.

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 or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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 the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings 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).

Event Materials

Title File Type/Size Source Organization
MCGP May 23, 2024 Webcast Link pdf (149.14 KB)
 
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