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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration  

[Docket No. FDA-2022-N-0589] 

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; establishment of a public docket; request for comments.

SUMMARY:  The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee.  The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.  The meeting will be open to the public.  FDA is establishing a docket for public comment on this document.

DATES:  The meeting will be held virtually on October 26, 2022, from 9 a.m. Eastern Time to 6:15 p.m. Eastern Time and October 27, 2022, from 9 a.m. Eastern Time to 3 p.m. Eastern Time.

ADDRESSES:  Please note that due to the impact of the COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.  Answers to commonly asked questions, including information regarding special accommodations due to a disability, may be accessed at:  https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FDA is establishing a docket for public comment on this meeting.  The docket number is FDA-2022-N-0589.  Please note that late, untimely filed comments will not be considered.  The docket will close on November 28, 2022.  The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 28, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. 

Comments received on or before October 11, 2022, will be provided to the committee. Comments received after that date will be taken into consideration by FDA.  In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.

You may submit comments as follows: 

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal:  https://www.regulations.gov.  Follow the instructions for submitting comments.  Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged.  Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process.  Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). 

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions):  Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:  All submissions received must include the Docket No. FDA-2022-N-0589 for “General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”  Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission.  You should submit two copies total.  One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.”  FDA will review this copy, including the claimed confidential information, in its consideration of comments.  The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.  Submit both copies to the Dockets Management Staff.  If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.”  Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law.  For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September18, 2015, or access the information at:  https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket:  For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:  Candace Nalls, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002, 301-636-0510, [email protected], 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 FDA’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 day 1, October 26, 2022, in the morning, the committee will discuss and make recommendations on the classification proposal for tissue expanders and accessories, which are currently unclassified preamendments devices, to be class III (general controls and premarket approval) and class II (general and special controls), and mammary sizers, which are currently unclassified preamendments devices, to be class II (general and special controls).  In the afternoon on the first day, the committee will discuss and make recommendations on the classification proposals for wound dressings with animal-derived materials, absorbable synthetic wound dressings, and hemostatic wound dressings with or without thrombin, which are all currently unclassified preamendments devices, to be class II (general and special controls).

On day 2, October 27, 2022, the committee will discuss and make recommendations on the classification proposals for nail prostheses, which are currently unclassified preamendments devices, to be class I (general controls); and ultrasonic surgical instruments, single-use reprocessed ultrasonic surgical instruments, and neurosurgical ultrasonic instruments, which are all currently unclassified preamendments devices, to be class II (general and special controls).

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 is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.  Scroll down to the advisory committee meeting link.

Procedure:  Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  All electronic and written submissions to the Docket (see ADDRESSES) on or before October 11, 2022, will be provided to the committee.  Oral presentations from the public will be scheduled on October 26, 2022, between approximately 9:30 a.m. and 10 a.m. Eastern Time, and 2 p.m. and 2:30 p.m. Eastern Time, and on October 27, 2022, between approximately 9:30 a.m. and 10 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 September 30, 2022.  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 3, 2022.

For press inquiries, please contact the Office of Media Affairs at [email protected] 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 [email protected] or 301-796-5966 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. app. 2).

Dated:  September 30, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

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