Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisor...
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Circulatory System 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 2 and 3, 2021, from 9 a.m. to 6 p.m. Eastern Time.
Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002,
Akinola.Awojope@fda.hhs.gov,
301-636-0512, 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 November 2, 2021, the committee will discuss and make recommendations on information about the benefit-risk profile of the Endologix AFX endovascular graft system with regards to the risk of Type III endoleaks. FDA requests panel input regarding the totality of data collected on AFX devices and whether further actions are necessary.
On November 3, 2021, the committee will discuss and make recommendations on the continued safety and effectiveness of endovascular stent grafts and how to strengthen real-world data collection on long-term performance of the devices, both for currently marketed devices and for future technologies. FDA intends to request panel input on the clinical outcomes that are most relevant to capture in the real world, along with their frequency and duration. Additionally, FDA intends to seek input on data collection platforms, and how to incentivize and optimize real world data collection.
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/advisory-committees/circulatory-system-devices-panel/2021-meeting-materials-
( printed page 47649)
circulatory-system-devices-panel.
Select the link for the 2021 Meeting Materials. 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 21, 2021. Oral presentations from the public will be scheduled on November 2 and November 3, 2021, between approximately 1 p.m. and 2 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, the date which they want to present, and an indication of the approximate time requested to make their presentation on or before October 13, 2021. 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 14, 2021.
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.
Use this for formal legal and research references to the published document.
86 FR 47648
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting,” thefederalregister.org (August 26, 2021), https://thefederalregister.org/documents/2021-18403/circulatory-system-devices-panel-of-the-medical-devices-advisory-committee-notice-of-meeting.