Contains Nonbinding Recommendations 
Procedures for Meetings of the 
Medical Devices Advisory Committee 
Guidance for Industry and 
Food and Drug Administration Staff 
 
Document issued on September 1, 2017 
The draft of this document was issued on April 1, 2015.  
This document supersedes Guidance on Amended Procedures for Advisory 
Panel Meetings, issued on July 22, 2000, and Panel Review of Premarket 
Approval Applications #P91-2 (blue book memo), issued on May 3, 1991. 
 
For questions regarding this document, contact James Swink at 301-796-6313 or 
James.Swink@fda.hhs.gov. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  Contains Nonbinding Recommendations 
Preface 
 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2015-D-0838. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies 
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 413 to 
identify the guidance you are requesting.  Contains Nonbinding Recommendations 
Table of Contents 
 
I.  Introduction .......................................................................................................................1
II.  Background.......................................................................................................................1
III.  Scope ..............................................................................................................................2
IV.  Panel Meeting Topics....................................................................................................2
A.  Advice on a Premarket Submission...........................................................................3
B.  Regulatory Issues.......................................................................................................3
(1)  Classification/Reclassification................................................................................3
(2)  General Issues .........................................................................................................4
V.  Panel Expertise..................................................................................................................4
VI.  Preparation for Panel Meetings ......................................................................................5
A.  Premarket Submission Meetings ................................................................................6
(1)  Briefing Material Contents.....................................................................................6
(2)  CDRH-Applicant Interactions................................................................................6
B.  Regulatory Issues Meetings.......................................................................................8
VII.  Conduct of Panel Meetings ............................................................................................8
A.  Medical Device Industry Presentations ......................................................................8
B.  CDRH Presentation....................................................................................................9
C.  Open Public Hearing..................................................................................................9
D.  Panel Deliberations and CDRH Questions............................................................... 10
E.  Panel Voting ............................................................................................................. 10
(1)  When to Vote ........................................................................................................ 11
(2)  Voting Procedure for Premarket Submission Panel Meetings ............................. 11
(3)  Indications for Use and Voting ............................................................................. 12
F.  Post Meeting Activities ................................................................................................ 12
G.  Teleconference Panel Meetings ............................................................................... 13
VIII.  References ................................................................................................................ 13
  Contains Nonbinding Recommendations 
Procedures for Meetings of the 
Medical Devices Advisory Committee 
Guidance for Industry and 
Food and Drug Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic. It does not establish any rights for any person and is not binding 
on FDA or the public. You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations. To discuss an alternative approach, contact the 
FDA staff responsible for this guidance as listed on the title page.  
I.  Introduction 
The Center for Devices and Radiological Health (CDRH) is issuing this guidance to provide 
information regarding the processes for meetings of the Medical Devices Advisory 
Committee panels other than the Medical Devices Dispute Resolution Panel (DRP).1 The 
term panel, as used in this guidance, refers to the panels described in the Medical Devices 
Advisory Committee charter, excluding the DRP. This guidance describes the general 
circumstances in which CDRH consults with a panel; the process for exchange of 
information between CDRH, the members of the panel, industry, and the public; and the 
conduct of panel meetings. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe FDAs current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in FDA guidance means that something is suggested or 
recommended, but not required. 
II.  Background 
The Medical Devices Advisory Committee includes 17 panels other than the DRP.2 The 
panels, according to their specialty area and authorization, advise the Commissioner in 
                                                 
1 For more information about the procedures of the Medical Devices DRP, see the FDA guidance, Center for 
Devices and Radiological Health Appeals Processes 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM28
4670.pdf). 
2 The Medical Devices Advisory Committee is comprised of the following panels other than the DRP: (1) 
Anesthesiology and Respiratory Therapy Devices; (2) Circulatory System Devices; (3) Clinical Chemistry and 
Clinical Toxicology Devices; (4) Dental Products; (5) Ear, Nose, and Throat Devices; 6) Gastroenterology and 
 
1  Contains Nonbinding Recommendations 
discharging responsibilities as they relate to assuring the safety and effectiveness of medical 
devices and, as required, any other product for which FDA has regulatory responsibility.3 A 
matter referred to a panel may relate to premarket or postmarket issues. 
This guidance is intended to provide information for industry and for CDRH staff on the 
processes associated with a panel meeting held for any of the reasons identified in this 
guidance. This guidance replaces Guidance on Amended Procedures for Advisory Panel 
Meetings 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm073722.htm) and Panel Review of Premarket Approval Applications #P91-2 (blue book 
memo) 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm081363.htm). This guidance also supplements existing FDA-wide guidance on the 
conduct of advisory committee meetings. 
III.  Scope 
This guidance applies only to panels of the Medical Devices Advisory Committee other than 
the DRP. It does not apply to other device-related or radiation-emitting product advisory 
committees, such as the Device Good Manufacturing Practice Advisory Committee, the 
National Mammography Quality Assurance Advisory Committee, or the Technical 
Electronic Product Radiation Safety Standards Committee. 
IV.  Panel Meeting Topics 
FDA may refer a matter to a panel either because it is legally required to do so or because it 
chooses to do so at its own discretion. FDA will take a premarket approval (PMA) 
application, a humanitarian device exemption (HDE) application, or a proposed product 
development protocol to a panel upon the request of an applicant, unless FDA finds that the 
information submitted substantially duplicates information which has previously been 
reviewed by a panel.4 When acting at its own discretion, CDRH intends to consider taking a 
matter before a panel if, among other things, the matter is of significant public interest or 
                                                                                                                                                       
Urology Devices; (7) General and Plastic Surgery Devices; (8) General Hospital and Personal Use Devices; (9) 
Hematology and Pathology Devices; (10) Immunology Devices; (11) Microbiology Devices; (12) Molecular 
and Clinical Genetics; (13) Neurological Devices; (14) Obstetrics and Gynecology Devices; (15) Ophthalmic 
Devices; (16) Orthopaedic and Rehabilitation Devices; and (17) Radiological Devices. For more information on 
the Medical Devices Advisory Committee, see 
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvis
oryCommittee/default.htm and 
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/default.htm
3 See the charter of the Medical Devices Advisory Committee at 
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvis
oryCommittee/ucm124098.htm. 
4 See section 515(c)(3)(B) & (f)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as 21 
CFR 814.44 and 814.116. 
2  Contains Nonbinding Recommendations 
there is additional or special expertise provided by the panel that could assist the Center in its 
decision-making. 
FDA may refer a matter to a panel for the following, with regards to medical device 
regulation: 
A.  Advice on a Premarket Submission 
Panels consisting of persons with expertise relevant to the medical device premarket 
submissions under review can provide valuable advice on the regulation of that medical 
device for CDRHs consideration. These meetings provide an opportunity for addressing 
scientific, clinical, or public health issues with broad public input, discussion by a panel of 
experts, and comment by interested parties. FDA may take any type of premarket 
submission, including a premarket approval (PMA) application, a humanitarian device 
exemption (HDE) application, a De Novo classification request, a premarket notification 
(commonly referred to as a 510(k) submission), or a proposed product development protocol, 
to a panel.  
Scenarios in which CDRH may seek panel input on premarket submissions include, but are 
not limited to: 
  novel technology expected to have a significant impact on clinical practice; 
  study results provide significant uncertainty as to whether the probable benefits of the 
device outweigh its probable risks (e.g., fails to meet pre-specified endpoints or reach 
statistical significance, presence of unanticipated serious safety concerns); and 
  significant study data quality or data integrity issues identified (e.g., substantial 
amounts of missing data, large number of protocol deviations, data integrity 
concerns). 
CDRH intends to consider panel review for multiple types of premarket submissions. The 
panels nonbinding recommendations are then considered as part of CDRHs decision 
whether to provide marketing authorization for the device. 
B.  Regulatory Issues 
CDRH may refer a matter to a panel for advice on regulatory actions or to discuss general 
scientific matters. These types of meetings include, but are not limited to: 
(1)  Classification/Reclassification 
FDA will seek a panels input as part of the classification of a preamendments device5 or as 
part of the process to reclassify such a device.6,7 In addition, FDA may, for good cause 
                                                 
5 See section 513(c)(1) of the FD&C Act and 21 CFR 860.84. 
6 See section 513(e)(1)(A)(i) of the FD&C Act. 
3  Contains Nonbinding Recommendations 
shown, refer a petition requesting reclassification of a postamendments device to a panel.8 
For example, full-field digital mammography systems, a postamendments device type, were 
presented to a panel in response to a reclassification petition submitted by a manufacturer 
requesting reclassification from class III to class II for certain indications.9 
(2)  General Issues 
CDRH may seek the panels expertise on scientific issues that are related to a device type or 
a general topic that is relevant to medical device safety and effectiveness but not related to 
any one particular device. For example, CDRH may request expert input in formulating 
recommendations for members of industry wishing to conduct a clinical trial of a device 
type, to inform the development of a guidance document, or to develop regulatory strategies 
to mitigate certain device risks. CDRH may also take postmarket safety issues to a panel 
meeting for recommendations. For example, the General Hospital and Personal Use Devices 
Panel provided advice to the FDA regarding clinical risks and benefits of postmarket actions 
in response to insulin pump failures.10 
V.  Panel Expertise 
Issues considered by the panels of the Medical Devices Advisory Committee are generally 
particular matters under 5 CFR 2640.103(a)(1). Thus, federal employees, including special 
government employees (SGEs), with disqualifying financial interests are generally prohibited 
from participating in the particular matter unless a waiver is granted. However, they may 
attend the panel meeting as a member of the public. Most panel members are SGEs. The 
panels may also include non-voting representatives (e.g., industry and consumer 
representatives). However, industry representatives are not SGEs and not subject to the same 
conflict of interest rules. For more information on conflict of interest as it relates to FDA 
advisory committees, please refer to the relevant FDA guidances, Guidance for the Public, 
FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict 
of Interest and Eligibility for Participation in FDA Advisory Committees 
(https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf) and 
Public Availability of Advisory Committee Members Financial Interest Information and 
Waivers 
(https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM295372.pdf). 
When a device is specifically the subject of review by a medical device advisory committee, 
CDRH will ensure that adequate expertise is represented on the panel to assess the disease or 
condition which the device is intended to cure, treat, mitigate, prevent, or diagnose, as well as 
                                                                                                                                                       
7 FDA will also seek panel input as part of an action to call for PMAs for a preamendments class III device. See 
section 515(b)(1) of the FD&C Act or 21 U.S.C. 360e(b)(1). Because this type of panel meeting does not 
concern a specific premarket submission, it typically falls under the Regulatory Issues meeting category 
rather than the Premarket Submission category. 
8 See section 513(f)(3) of the FD&C Act.  
9 See 75 FR 68200. 
10 See 75 FR 1396. 
4  Contains Nonbinding Recommendations 
the technology of the device.11 Adequate expertise is defined in statute to mean that the 
membership of the advisory committee includes two or more voting members with a 
specialty or other expertise clinically relevant to the device under review and at least one 
voting member who is knowledgeable about the technology of the device.12  
VI.  Preparation for Panel Meetings 
The sections below describe steps taken prior to a panel meeting, including the development 
and release of briefing materials prepared for the open portions of panel meetings, consistent 
with 5 U.S.C App 2.13 For more information on briefing materials, please refer to Advisory 
Committee Meetings  Preparation and Public Availability of Information Given to Advisory 
Committee Members (hereinafter, FDA Advisory Committee Meetings Guidance; 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125650.pdf). 
Panel meetings are scheduled based on the availability of necessary SGEs; FDA staff; 
applicant14 staff, such as clinical investigators and other experts; and an appropriate meeting 
venue. A notice in the Federal Register (FR) must be published at least 15 calendar days 
prior to any federal advisory committee meeting,15 including those held by FDA, unless there 
is an emergency or an immediate meeting is required for other reasons.16 When possible, 
CDRH should announce its meetings in the FR at least 6 weeks prior to the meeting. 
Upcoming FDA advisory committee meetings are announced on FDAs Advisory Committee 
Calendar, which is available at 
http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. The public, including any 
stakeholders that may be impacted by the deliberations of a panel, are encouraged to submit 
relevant information to the related Federal Register docket via http://www.regulations.gov in 
advance of the panel meeting. The public may also submit written materials directly to the 
Designated Federal Officer (DFO) as announced in each FR notice. A DFO will be assigned 
to provide administrative support for the panel meeting, including helping the applicant 
throughout the panel preparation period and assisting in the preparation of background 
materials. All panel-related questions should be relayed through the DFO listed in the FR 
notice. 
                                                 
11 See section 513(b)(5)(B) of the FD&C Act. 
12 See section 513(b)(5)(C) of the FD&C Act. 
13 No FDA advisory committee meeting may be entirely closed to the public (21 CFR 14.27(a)). However, 
sometimes a portion of a meeting will be closed to the public under 5 U.S.C. 552b(c) and 21 CFR 14.27. This 
section only applies to briefing materials prepared for the open portions of panel meetings. 
14 For purposes of this guidance, applicant refers to a party who submits a premarket submission that is the 
subject of a Premarket Submission panel meeting, e.g., the 510(k) submitter or the PMA applicant. 
15 See 41 CFR 102-3.150. 
16 See 21 CFR 14.20(a). 
5  Contains Nonbinding Recommendations 
A.  Premarket Submission Meetings 
(1)  Briefing Material Contents 
Under most circumstances, Premarket Submission panel meeting topics involve deliberations 
regarding a single medical device for which marketing authorization is sought. Regardless of 
the submission type under which a device is being reviewed (PMA, 510(k), De Novo, or 
HDE), CDRH intends to provide to the panel members and the applicant a prepared panel 
package of briefing materials, referred to as the Panel Pack, which may include: 
  FDAs agenda; 
  FDAs Executive Summary; 
  FDAs draft questions for panel consideration; 
  FDAs voting questions; 
  any information deemed relevant by the FDA (e.g., publications/literature); 
  applicant-provided briefing materials as requested in an information letter 
communicated from FDA.17 These may include: 
o  Executive Summary; 
o  appropriate sections or excerpts from the submission; 
o  proposed labeling; 
o  protocol(s), to the extent that these were included in the submission; and 
o  relevant publications/literature from the submission. 
(2)  CDRH-Applicant Interactions 
CDRH recommends the following practices for interactions between the applicant and 
CDRH on panel briefing materials for a meeting where input on a premarket submission is 
sought. These recommendations further inform the timelines for review of releasable or non-
releasable information, as contained in the FDA Advisory Committee Meetings Guidance. If, 
no later than 7 business days after notification that their submission is to be presented at a 
panel meeting, the applicant requests a phone call or meeting with CDRH to discuss the 
panel meeting logistics and preparation, FDA intends to call or meet with the applicant. As 
indicated in the Appendices of the FDA Advisory Committee Meetings Guidance, the times 
by which applicants should submit briefing materials differ depending on whether the 
materials contain information that the applicant claims is exempt from disclosure under the 
Freedom of Information Act (FOIA; 5 U.S.C. 552). 
                                                 
17 As discussed below, the Panel Packs will be redacted to protect any information that is exempt from public 
disclosure under the Freedom of Information Act. For more details about confidentiality of information, see 21 
CFR 807.95, 21 CFR 814.9, 21 CFR 814.122, 21 CFR 860.5, and 21 CFR part 20, as well as the FDA guidance, 
Guidance for Industry - Advisory Committee MeetingsPreparation and Public Availability of Information 
Given to Advisory Committee Members 
(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125650.pdf). 
6  Contains Nonbinding Recommendations 
If an applicant chooses to prepare briefing materials that contain information that they 
believe is exempt from disclosure under FOIA, they should prepare two versions of its 
briefing materials: one version should be complete (unredacted) and the second version 
should be a publicly releasable version (redacted). The complete version of the briefing 
materials should be marked Draft: Advisory Committee Briefing Materials: Not for Public 
Release: Contains Trade Secret and/or Confidential Commercial Information. Both the 
complete (unredacted) and redacted version of the briefing materials should be submitted 42 
business days before the advisory committee meeting, in accordance with Appendix B of the 
FDA Advisory Committee Meetings Guidance. When CDRH receives briefing materials by 
42 business days before the meeting, CDRH intends to review the materials for completeness 
and relevance. Between 42 and 22 business days before the meeting, CDRH and the 
applicant may engage in informal discussions of the accuracy, relevance, completeness, and 
appropriateness of briefing materials and proposed redactions. 
If an applicant chooses to submit fully releasable briefing materials, they should mark the 
materials as Advisory Committee Briefing Materials: Available for Public Release and 
submit their briefing materials no later than 22 business days before the advisory committee 
meeting, in accordance with Appendix A of the FDA Advisory Committee Meetings 
Guidance. 
CDRH will send the final unredacted Panel Pack to all of the panel members, who are SGEs 
or other government employees, and the applicant. In addition, CDRH will send a redacted 
version of the Panel Pack to the Industry Representative.18 No less than 2 full business days 
before the panel meeting, CDRH will post on the FDA website both the applicants and 
CDRHs redacted briefing materials to make them publicly available. 
Approximately 5 business days prior to the meeting, the applicant and CDRH should 
exchange draft slides intended for presentation to the panel at the meeting. The applicant 
should identify any slides containing new information or data and clearly indicate that the 
information contained in the slide has not been reviewed by the FDA. No later than the day 
of the panel meeting, the applicant and CDRH should discuss any final concerns or changes 
in the presentations prior to the start of the panel meeting. 
The Panel Pack and applicant presentation should generally only include information that 
was included in the submission or agreed upon for inclusion by CDRH. If additional 
information, data, and/or analyses are included by the applicant, CDRH recommends the 
applicant notify CDRH and provide the additional information, data, and/or analyses as soon 
as possible. If new data or significant new analyses are submitted between 55 business days 
and 22 business days prior to a panel meeting, CDRH may postpone the panel meeting 
pending review of the new material. If CDRH agrees to proceed with the scheduled panel 
meeting, the affected sections of the Panel Pack should prominently note that such 
information was not provided to CDRH by the recommended timelines and, as such, has not 
been reviewed by CDRH. Applicants are advised that such late submission may impair the 
panels ability to consider this information before the meeting. CDRH will not consider new 
                                                 
18 See 21 CFR 14.86(a)(2). 
7  Contains Nonbinding Recommendations 
documents or information for the Panel Packs later than 22 business days prior to the 
meeting. 
B.  Regulatory Issues Meetings  
In general, Regulatory Issues panel meeting topics involve deliberations that impact a device 
type or multiple device types. 
For these meetings, CDRH intends to provide to the panel members a Panel Pack that 
contains: 
  FDAs agenda; 
  FDAs Executive Summary; 
  FDAs questions for panel consideration; and 
  any information deemed relevant by the FDA (e.g., manufacturer material, such as 
relevant portions of a reclassification petition; publications/literature). 
Consistent with the FDA Advisory Committee Meetings Guidance, CDRH intends to make 
available on its website, no later than 2 full business days in advance of a Regulatory Issues 
panel meeting, the publicly available briefing information from the Panel Pack. 
VII. Conduct of Panel Meetings 
This section describes the events that can or must occur during panel meetings, including 
industry and CDRH presentations, the open public hearing, panel deliberations, and voting 
procedures. The order of discussion of the presentations below does not necessarily reflect 
the order of presentations at a panel meeting. 
A.  Medical Device Industry Presentations 
Under section 513(b)(6)(A)(iii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 
any person whose device is specifically the subject of review by a panel shall have the same 
opportunity as the Secretary to participate in meetings of the panel, including, subject to the 
discretion of the panel chairperson, by designating a representative who will be provided a 
time during the panel meeting to address the panel for the purpose of correcting 
misstatements of fact or providing clarifying information, and permitting the person or 
representative to call on experts within the persons organization to address such specific 
issues in the time provided.  
Further, section 513(b)(6)(B) of the FD&C Act, before and after amendment by the 21st 
Century Cures legislation, requires that meetings shall: (1) provide adequate time for initial 
presentations; and (2) encourage free and open participation by all interested persons. 
Accordingly, FDA continues the policy that for Premarket Submission panel meeting topic 
presentations, an applicant will generally have 60 minutes, or up to 90 minutes if (1) the 
applicant submits a request and the DFO accepts that request or (2) the CDRH presentation is 
scheduled for 90 minutes. In addition, new section 513(b)(6)(B)(ii) provides that following 
8  Contains Nonbinding Recommendations 
the initial presentations, the panel may pose questions to a designated representative and 
consider the responses to such questions in the panels review of the device. 
Industry presentations for Regulatory Issues panel meetings are encouraged, and a segment 
of the panel meeting agenda should be designated for this purpose. If industry stakeholders 
request time to speak in advance, the same 60 (or 90) minute presentation slots described 
above will generally be provided. However, the timeslot for the affected persons may be 
divided among those that have requested time to present information to the panel. Industry 
stakeholders who wait until the day of the panel meeting to request time to speak will be 
allowed to speak at the discretion of the Panel Chair. 
B.  CDRH Presentation 
CDRH intends to present any necessary regulatory background and its review and assessment 
of the scientific and/or clinical information for which panel input is requested. CDRH's 
presentation is generally limited to 60 minutes, but up to 90 minutes may be allotted due to 
the complexity of the review (or other) issues. FDAs slides typically present the Agencys 
scientific and/or regulatory view of the issues at hand and ask for specific input from the 
panel regarding FDAs questions. 
Depending on the complexity of the regulatory issues being discussed, CDRH may opt to 
conduct pre-meeting training for the panel members (including any non-voting industry, 
consumer, or patient representatives). Such training could include discussion of general 
regulatory and/or statutory terminology and the applicability of CDRHs regulations to the 
panel meeting topic, such as classification/reclassification procedures, regulations related to 
medical device marketing submissions, etc. Any pre-meeting training should provide general 
background and should not include information specific to any device(s) being discussed in 
the panel meeting. The panel should not deliberate on any material being brought before the 
panel during pre-meeting training nor provide any advice to the Center on the training 
materials. Subject to FOIA, the training materials should be made available for public 
disclosure upon request. 
C.  Open Public Hearing 
Every advisory committee meeting includes an open public hearing (OPH) session, during 
which interested persons may present relevant information or views orally or in writing.19 
FDAs regulation, 21 CFR 14.29(a), requires that a minimum of 60 minutes per meeting be 
dedicated to an OPH session for oral presentations, unless public participation does not last 
that long, at which time the OPH will generally be concluded. The OPH for panel meetings 
should be conducted in accordance with the FDA guidance, The Open Public Hearing at 
FDA Advisory Committee Meetings 
(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM236144.pdf). 
                                                 
19 See 21 CFR 14.25(a). 
9  Contains Nonbinding Recommendations 
D.  Panel Deliberations and CDRH Questions 
There should be approximately 1 hour designated for general panel deliberations. During 
their deliberations and before addressing the CDRH questions, the panel may require 
clarification or have questions about the information presented. In such cases, both CDRH 
and the affected person(s) should be provided an equal opportunity to respond to questions 
from panel members. The applicant or affected person, during this time, may approach the 
lectern in order to be recognized by the Panel Chair to speak at the Chairs discretion. Under 
section 513(b)(6)(B)(ii) of the FD&C Act, the panel may pose questions to a designated 
representative, as described in Section VII.A, and consider the responses to such questions in 
the panels review of the device.  
Once the general panel deliberations are completed, CDRH should ask specific questions to 
the panel. Additional input from interested parties, including an applicant, should be allowed 
at the discretion of the Panel Chair. In order for the panel to provide useful information to 
both CDRH and other interested parties and to allow the panel more time to discuss the 
issues, CDRH will generally request that the panel members provide their scientific opinions 
and recommendations to the questions posed by CDRH without interruption. 
Prior to conducting the vote, if any, the applicant, FDA, industry representative, consumer 
representative, and patient representative should be provided an opportunity to present 
viewpoint summations. For certain panel meetings regarding device classification, panels are 
also asked to provide recommendations to CDRH containing the information specified in 21 
CFR 860.84(d). 
E.  Panel Voting 
The voting procedures for panel meetings are described in 21 CFR 14.22(d). In general, 
matters are to be considered by all voting members present at the time, although the DFO 
may require that any final report be voted upon by all current voting members of the panel. 
There are no specific provisions in FDA regulations for absentee voting or proxy voting. A 
member who leaves the meeting prior to the vote should not be able to cast a vote. All voting 
should be conducted in public view. The list of voting members and those appointed as 
temporary voting members should be read into the record at each panel meeting. The Charter 
for the Medical Devices Advisory Committee describes who may vote for the issue at hand. 
By statute, the consumer representative and industry representative are non-voting members 
of a panel.20 For more information on voting procedures, please refer to the Charter 
(http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/M
edicalDevicesAdvisoryCommittee/ucm124098.htm) and the FDA guidance, Voting 
Procedures for Advisory Committee Meetings 
(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125641.pdf). 
                                                 
20 See section 513(b)(2) of the FD&C Act. 
10  Contains Nonbinding Recommendations 
(1)  When to Vote 
The formal voting process is typically used for panel meetings involving a specific device 
marketing submission, i.e., Premarket Submission meetings. For Regulatory Issues meetings 
involving classifications or reclassifications, guidance documents, and other general issues 
brought to panel, the panel should be asked to discuss the issues and provide 
recommendations on questions asked by CDRH, but no formal vote will generally be taken. 
(2)  Voting Procedure for Premarket Submission Panel 
Meetings 
For meetings regarding PMA applications, the voting members of a panel are typically asked 
to respond to three questions relating to safety, effectiveness and benefit versus risk for 
specific devices that are the subject of a PMA application. After completion of the panel 
deliberations and after discussion of the CDRH questions as explained in Section VII.D of 
this guidance, CDRH intends to ask panel members to vote simultaneously by open ballot or 
via electronic voting, and each vote for each question will be associated with a specific panel 
member. Panel members should be instructed to vote on the following questions relating to 
the approvability of the device based on their expertise, the information they reviewed in 
preparation for the meeting, and the information presented at the meeting: 
Voting Question 1: 
Is there reasonable assurance that X device is safe for indication(s) A (and B, etc.)? 
Voting Question 2: 
Is there reasonable assurance that X device is effective for indication(s) A (and B, etc.)? 
Voting Question 3: 
Do the probable benefits of X device for indication(s) A (and B, etc.) outweigh the 
probable risks of device X for indication(s) A (and B, etc.)? 
When other types of submissions are the subject of a Premarket Submission panel meeting, 
questions relevant to those submissions should be presented to the panel (i.e., for a 510(k), 
the panel may vote on substantial equivalence; for an HDE submission, the panel may vote 
on probable benefit). For example, the voting questions for an HDE application should read 
as follows: 
Voting Question 1: 
Will X device expose patients to an unreasonable or significant risk of illness or injury 
when used for indication(s) A (and B, etc.)? 
Voting Question 2: 
Does X device offer sufficient probable benefit for the proposed indications for use? 
11  Contains Nonbinding Recommendations 
Voting Question 3: 
Do the probable benefits to health from use of X device outweigh the risk of injury or 
illness from use for the proposed indications, taking into account the probable risks and 
benefits of currently available devices or alternative forms of treatment? 
After voting, panel members should be asked to state how they answered each question and 
to explain their answers. The panel may discuss changes to labeling, restrictions on use, 
longer term follow-up, or other controls that may alter the benefit-risk calculus, in order to 
give the applicant constructive feedback on their submission. 
If the evidence provided is insufficient to allow for any of the determinations, the voting 
panel member should state this as the reason for answering no. A description of any 
remedial or mitigating studies or actions should be given. 
(3)  Indications for Use and Voting 
The Indication(s) for Use (IFU) to be voted on should be the IFU as described in the FDA 
Executive Summary in the Panel Pack provided by CDRH prior to the meeting (see Section 
VI.A(1) above). The FDA Executive Summary relies on what was submitted by the applicant 
in the original submission, unless the submission was amended in a subsequent submission as 
described in Section VI.A(2). Proposed changes or modifications to the IFU and what would 
be needed to support such changes may be discussed during the panel deliberation portion of 
the meeting; however, the vote itself should be on the IFU as stated in the FDA Executive 
Summary. The members of the panel should be afforded an opportunity to explain their vote. 
After voting, the panel may discuss whether a change in the IFU could have an impact on the 
benefit-risk calculus. Such discussion should also include what additional pre- or postmarket 
data or scientific information, if any, would be needed to pursue new IFU. If the original IFU 
as presented to the panel receives any unfavorable votes, the following question should be 
posed to the voting members of the panel for their consideration: 
If you answered no to any question, please state whether changes to the IFU, 
restrictions on use, or other controls, would make a difference in your answer. 
Although a formal vote on the different is not necessary and will not generally be conducted, 
the considerations and concerns of the voting panel members should be clearly articulated for 
the record. 
F.  Post Meeting Activities 
A brief summary of the meeting should be posted to the FDAs website no later than 2 
business days after the meeting. An official transcript of the proceedings should be posted to 
the FDAs website as soon as it is available, no later than 60 days after the meeting. 
Following the meeting, FDA should review the panel proceedings in their entirety and should 
continue to work interactively with the applicant(s) or stakeholders. 
12  Contains Nonbinding Recommendations 
G.  Teleconference Panel Meetings 
Panel meetings may be held by conference telephone call as provided for in 21 CFR 
14.22(g), 860.125, and 814.44(b). Teleconference panel meetings will generally be limited to 
discussion topics that are anticipated to be brief. They are authorized when the meeting will 
be conducted to confirm the recommendations from a previously held traditional panel 
meeting or where time does not permit a meeting to be held at a central location. In addition, 
teleconference panels may be held to speed the classification of multiple device typesin 
particular, classification of lower risk device types which are no longer in general use or for 
which significant valid scientific evidence exists, and for which the proposed classification is 
expected to be non-controversial and readily confirmed by the panel. 
For teleconference panel meetings, some or all of the panel members, other than the Panel 
Chair, may participate from remote locations. Multiple topics requiring participation by 
different panel members may be combined into a single day. The Panel Chair and DFO will 
manage the deliberation, question and answer, and OPH portions of the meeting consistent 
with the requirements of 21 CFR Part 14. As described in 21 CFR 14.22(g), interested parties 
will be afforded an opportunity to participate in the meeting. A speaker phone will be 
provided at a conference room located in Washington, DC, or Rockville, MD, or the 
immediate vicinity. Members of the public should be afforded the opportunity to provide 
statements to the panel as described in Sections VII.A and VII.C above. 
VIII.  References 
  Medical Devices Advisory Committee, Information and Materials: 
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/
default.htm 
  Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: 
Public Availability of Advisory Committee Members Financial Interest Information and 
Waivers 
(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM295372.pdf) 
  Open Public Hearing: Guidance for the Public, FDA Advisory Committee Members, 
and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings 
(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM236144.pdf) 
  Panel Packs/Freedom of Information: Guidance for Industry Advisory Committee 
Meetings  Preparation and Public Availability of Information Given to Advisory 
Committee Members 
(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125650.pdf) 
  Conflict of Interest: Guidance for the Public, FDA Advisory Committee Members, and 
FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for 
Participation in FDA Advisory Committees 
(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf) 
  Voting Procedures: Guidance for FDA Advisory Committee Members and FDA Staff: 
Voting Procedures at Advisory Committee Meetings 
(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125641.pdf) 
13  Contains Nonbinding Recommendations 
  Dispute Resolution Panel: Center for Devices and Radiological Health Appeals 
Processes: Guidance for Industry and Food and Drug Administration Staff 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/UCM284670.pdf) 
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