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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA–2021–N–0008]

Patient Engagement Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee. The general function of the committee is to provide advice to the Commissioner of Food and Drugs, or designee, on complex scientific issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.

DATES: The meeting will take place virtually on October 6, 2021, from 10 a.m. to 5 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID–19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information on how to access the webcast will be made available no later than 2 business days prior to the meeting at http://www.fdalive.com/PEAC/.

FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993–0002, [email protected],  301–796–8398, 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/advisory-committees and scroll down to the appropriate advisory committee meeting link or call the advisory committee information line to learn about possible modifications.

SUPPLEMENTARY INFORMATION:

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On October 6, 2021, the committee will discuss and make recommendations on the topic ‘‘Medical Device Recalls.’’ Once a medical device is available in the U.S. marketplace and in widespread use, unforeseen problems can sometimes lead to a recall. When a device is defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public. A company may recall a device after discovering a problem on its own, or after FDA raises concerns. In rare cases, FDA may require a company to recall a device. When a device is recalled, FDA reviews the company’s strategy for resolving the problem by assessing the relative degree of risk associated with the product and making sure the strategy effectively resolves the problem with the device. FDA provides transparency and communicates information when the public needs to be alerted to a serious hazard, as well as once the recall has been appropriately resolved. The recommendations provided by the committee will address factors FDA and industry should consider to effectively communicate medical device recall information to patients and the public, including but not limited to content, format, methods used to disseminate the message, and timing of communication. The committee will also consider concerns patients have about changes to their device in response to a recall and will discuss ways patient perspectives could be incorporated in FDA and industry benefit-risk decision making, as well as the healthcare provider and patient decision-making process related to a recalled medical device, including implanted devices.

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 materials will be available at https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee. 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. Oral presentations from the public will be scheduled on October 6, 2021, between approximately 2 p.m. to 3 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 September 8, 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 September 10, 2021. Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by the committee may send written submissions to the contact person on or before September 16, 2021.

Virtual Breakout Session:
Individuals interested in participating in the virtual breakout scenario discussions will need to sign up to participate on or before September 22, 2021. The signup sheet, as well as, additional information pertaining to the virtual scenario discussions will be available at http://www.fdalive.com/PEAC/.  Everyone who signs up in advance and provides a valid email address will receive an email at least 2 days prior to the meeting with information on how to access the virtual platform that will host the virtual breakout scenario discussions. Please note due to limited technology capacity, participation in the virtual breakout scenario discussions will be limited to 150 participants. Once capacity reaches 150 participants, the breakout session will be closed to additional participants. Additional information regarding the virtual breakout scenario discussions will be provided at http://www.fdalive.com/PEAC/.

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 AnnMarie 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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings for procedures on public conduct during advisory committee meetings. Please be advised that, during the virtual scenario breakout discussions, FDA will prepare a summary of the discussion in lieu of detailed transcripts.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: August 6, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

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