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 CDRHGuidance@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

1

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.

FDA’s guidance documents, including this guidance, do not establish legally enforceable

responsibilities. Instead, guidances describe FDA’s 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 
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.

2

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.
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 CDRH’s 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 

panel’s nonbinding recommendations are then considered as part of CDRH’s 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 panel’s input as part of the classification of a preamendments device

3

5 or as 

part of the process to reclassify such a device.6,7In 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.
Contains Nonbinding Recommendations

shown, refer a petition requesting reclassification of a postamendments device to a panel.

4

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 panel’s 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.
Contains Nonbinding Recommendations

the technology of the device.

5

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 FDA’s 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).
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:

· FDA’s agenda;

· FDA’s Executive Summary;

· FDA’s draft questions for panel consideration;

· FDA’s 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.

6

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 nonreleasable 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 Meetings—Preparation and Public Availability of Information 

Given to Advisory Committee Members” 

(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125650.pdf).
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.

7

18 No less than 2 full business days 

before the panel meeting, CDRH will post on the FDA website both the applicant’s and 

CDRH’s 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 

panel’s ability to consider this information before the meeting. CDRH will not consider new 

 

18 See 21 CFR 14.86(a)(2).
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:

· FDA’s agenda;

· FDA’s Executive Summary;

· FDA’s 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 person’s 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 panel’s 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. FDA’s slides typically present the Agency’s 

scientific and/or regulatory view of the issues at hand and ask for specific input from the 

panel regarding FDA’s 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 CDRH’s 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.

9

19

FDA’s 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).
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 Chair’s 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 panel’s 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.

10

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.
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:

11

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?
Contains Nonbinding Recommendations

Voting Question 3:

12

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 FDA’s website no later than 2 

business days after the meeting. An official transcript of the proceedings should be posted to 

the FDA’s 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.
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 types—in 

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/

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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)
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

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eDocuments/UCM284670.pdf)