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1

June 1, 2015

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. FDA- 2015-D-0838: “Procedures for Meetings of the Medical Devices

Advisory Committee; Draft Guidance for Industry and Food and Drug

Administration Staff.”

Dear Sir or Madam:

The Advanced Medical Technology Association (“AdvaMed”) is pleased to provide

comments on FDA’s draft guidance “Procedures for Meetings of the Medical Devices

Advisory Committee; Draft Guidance for Industry and Food and Drug Administration Staff.”

AdvaMed represents manufacturers of medical devices, diagnostic products, and health

information systems that are transforming health care through earlier disease detection, less

invasive procedures, and more effective treatment. Our members range from the smallest to

the largest medical technology innovators.

Generally speaking, industry is encouraged that FDA has provided much needed clarity

around key issues concerning how the medical device advisory committees operate, and

greatly appreciates the issuance of this draft guidance. The guidance is especially valuable

for clarifying the appropriate participation of sponsors and other experts during panel

reviews.

Our specific comments on the draft guidance include recommended changes and the

associated change justification/ explanation, and are provided in an attachment to this letter.

Additionally, a line-numbered version of the draft guidance is also attached to facilitate your

review.

General Comments:

Predictable and Transparent Process: Advisory committee reviews, or panels, are a

critical step in the premarket review of many devices. The panel reviews take place very

late in the process and after significant time and resources have been put into preclinical

and clinical testing. A predictable transparent and fair process is important for the

sponsor and all other stakeholders.

Docket No. FDA-2015-D-0838

June 1, 2015

Page 2 of 13

Eliminate/Revise Affected Guidance Documents: This guidance overlaps with multiple

guidance documents and therefore, to limit the proliferation and control of redundant

information, we recommend amending/finalizing the existing guidance documents with

the additional clarifying information contained within this newly drafted guidance. (See,

e.g., “Availability of Information Given to Advisory Committee Members in Connection

with CRDH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff:

Issued for comments July, 2001;” “Guidance for Clinical Investigators, Industry, and

FDA Staff; Financial Disclosure by Clinical Investigators, Feb. 2013”). Similarly, this

guidance provides information beyond the “Summary of Changes to CDRH’s Advisory

Committee Process” (ca. 2010). That document should be removed from the FDA

website and superseded by this guidance.

Identify Panel Membership: Add a section identifying membership of an advisory panel

and the role of the membership, particularly the role of the industry representative,

consumer representative and patient representative. This information would be helpful

for industry and clarify those who are voting members and nonvoting members, and their

role in an advisory committee meeting. Further, in lines 307-308 and 343, FDA

discusses voting members and non-voting members but never sets the context for who

these members are and what their role is.

Panel Voting: Often, there is confusion at the at the beginning of the panel meeting

regarding the voting process, as it concerns the indications that are put forth in the PMA,

and how voting members would amend their vote based on changes to the labeling. FDA

should consider two points at which panel members vote: Once as is done currently with

indications as identified in the PMA and second with any proposed changes to indications

as discussed by the panel, i.e., as prescribed in this draft guidance, except that the second

vote should be mandatory, not at the discretion of the chair.

Further, the voting questions of safety, efficacy, and benefit/risk can result in an

imbalanced outcome. For example, a member may vote “NO” to the efficacy question,

and the same member may vote “YES” to the benefit/risk question. This result has been

demonstrated in several panel meetings and illustrates the confusion associated with

posing these three separate questions to the panel in the current fashion. It seems

illogical that one can believe a device does not have reasonable assurance to be effective

for the intended use, yet believe at the same time that the potential benefits outweigh the

risks of using the device. FDA should consider clarifying or revising these questions in

an effort to reduce confusion.

Add Post Advisory Committee Meeting Activities: FDA should also include within this

guidance a general description and timeline regarding post advisory committee meeting

activities such as FDA 24-hour summary and the public availability of the panel

transcript.

Docket No. FDA-2015-D-0838

June 1, 2015

Page 3 of 13

Specific Comments:

Please refer to the attachment of this letter for specific comments on this guidance and

additional examples of scenarios for clarification.

Thank you for the opportunity to submit comments on this draft guidance document.

Respectfully submitted,

/s/

Sharon A. Segal, Ph.D.

Vice President

Technology and Regulatory Affairs

Attachment

ADVAMED COMMENTS Procedures for Meetings of the Medical Devices Advisory Committee; Draft Guidance for Industry and Food and Drug Administration Staff

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Line(s) No. – Line or lines numbers of the guidance Change – Proposed change to the guidance Reason – Reason/Rationale for proposed change

Line(s) No. Change Reason

1. 51

Consider adding a link to the Medical Devices Advisory Committee’s web page in the guidance document and a note about the role of the Medical Devices Advisory Panel Coordinator.

Given this guidance document is specific to Medical Devices, additional information may provide more clarity.

2. 51-63

Revise to read as follows:

“The Medical Devices Advisory Committee consists of 18 panels. With the exception of the Medical Device Dispute Resolution Panel the remaining 17 panels, according to their specialty area authorization, advise the Commissioner about issues related to safety and effectiveness of Medical Devices. The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers. includes 17 panels other than the DRP

2. The panels, according to their

specialty area and authorization, advise the Commissioner in discharging responsibilities as they relate to assuring the safety and effectiveness of medical devices, and as required, any other product for which the Food and Drug Administration has regulatory responsibility.’

Provides consistency in the information available on FDA’s website and the guidance document. Also provides additional detail on the background as to why DRP is out of scope.

Clarification: “discharging responsibilities” may be interpreted to be more authoritative rather than advisory role.

3. 146-160 Move the information on conflicts of interest into a separate section

The information as presented is confusing and would be better presented in a separate section. Moreover, this section also should clarify that the disqualifying financial interests are determined by the agency and not the medical device manufacturer.

Further, FDA should either acknowledge in this guidance document, or update the 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 to address how FDA also considers financial information that

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Line(s) No. Change Reason

is publicly disclosed under the Sunshine Act in the determination for conflicts of interest.

4. 167-168

Revise to read as follows:

“Panel meetings are scheduled based on the availability of necessary SGEs, FDA staff, sponsor

6 staff, clinical

investigators, and other experts…”

Include clinical investigators and other experts as typical participants in advisory committee meetings.

5. 168-169

Add timeframe for Federal Register posting and information included in the announcement:

Revise to read as follows:

All panel meetings are announced in the Federal Register a minimum of 6 weeks prior to the panel meeting. Announcements include, date of the panel meeting, company name, topic ……….”

Provides additional guidance and clarity of the process.

6. 188-196

Include these additional items for panel package in the numbered list

Panel voting options and definitions

Waivers, if applicable

Provides comprehensive listing for Panel Pack.

7. 192-195

Revise to read as follows:

“5. Sponsor identification of aAppropriate sections or excerpts from the submission (e.g., relevant nonclinical and clinical data, draft summary of safety and effectiveness data, proposed physician and patient labeling, proposed post approval study);

6. Any information deemed relevant by the FDA or the sponsor (e.g. publications/literature);”

This information is typically also provided in the panel pack. This section should clarify who is responsible for what for all parts of the panel pack. Moreover, information deemed relevant by the sponsor may also be added, following discussion with FDA and/or submission to the application.

8. 203

Add the following:

“Approximately [XX] days into the premarket review cycle FDA sends the sponsor a letter with the intention of referring the matter to an advisory panel and the basis for this decision is …...”

The timeline as identified starts at 55 days before the panel meeting without acknowledgement that the sponsor should already have been notified by FDA via email, phone or letter of the need for an advisory panel meeting. Consider adding a timeframe to notify the sponsor that CDRH intends to take its matter to an advisory panel and the basis for the decision to clarify the regulatory path.

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9. 203-234 Where applicable, add e-copy and paper copy instructions.

FDA should clarify in this section their request for e-copy versions and paper copy versions. This would clarify for the sponsor how FDA would like to receive and review this information.

10. 207

For item #2, please define:

FDA expectations with respect to a formal response to the Advisory Committee Information Letter, informal e-mail, teleconference, etc.

Sponsor should discuss with FDA within [XX] days of receiving Advisory Committee Information Letter.

Specify any limitation on ‘Additional Information’ (e.g., new data or significant new analysis not previously reviewed by FDA).

Clarification.

11. 203-209

During the 55 business days described, CDRH should identify significant issues or concerns it has regarding the safety, effectiveness or risk/benefit data. CDRH should be required to meet with the Sponsor to discuss issues, if requested.

Under the proposed timeline, the Sponsor will not see CDRH’s Panel Pack material until as little as 5½ weeks before panel. This does not give the Sponsor enough time to react to serious CDRH concerns about the data on which approval will be decided.

12. 210-213

Revise to read as follows:

“The sponsor should submit two an unredacted versions of its proposed sections of the panel pack to CDRH: a complete (unredacted) version and a redacted version for FDA Freedom of Information (FOI) review in accordance with 21 CFR 20.”

Consider allowing the sponsor to submit an un-redacted version of the panel pack to CDRH for review prior to submitting the redacted version rather than at the same time.

This section needs to clarify that this is not a complete final version of the panel pack and should mention the ability to put a placeholder for the executive summary as it is typically not complete at this point. Overall, the timeline to prepare the Panel Pack is very short and this guidance highlights that there are only 13 days from the time that CDRH sends the sponsor the Advisory Committee information letter to the time that the sponsor is requested to submit a version of the proposed section of the panel pack. FDA should seriously consider extending this timeframe to at least four weeks (20 business days). Further, this guidance should acknowledge the fluidity of the Panel Pack before the panel meeting and the interactive discussions that CDRH and the Sponsor

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have during this period to generate the final Panel Package.

13. 215-224

The Sponsor should have the opportunity to comment not only on factual errors in the information proposed by CDRH but also on the completeness and relevance of the content, just as CDRH will comment on the completeness and relevance of the Sponsor’s material. CDRH should be required to meet with the Sponsor to discuss Panel Pack contents, if requested.

If CDRH is taking an antagonistic approach to the presentation and interpretation of the Sponsor’s data, the Sponsor should have an opportunity to rebut this. Every effort should be made on the part of CDRH to be transparent about its position and to gain alignment with the Sponsor, if possible. If alignment cannot be gained, the Sponsor should have a clear understanding of CDRH’s position. This position should be articulated in a meeting with open discussion, if requested. (See comment #22)

14. 220-224

For item #2 please define:

FDA’s expectations with respect to when the sponsor can expect to receive FDA’s executive summary for review.

For item #3 please define:

Who will provide information to the sponsor regarding the adequate number of un-redacted copies and where to send the copies or cross reference where this information is provided.

Additional review time is a welcomed change.

Confidential nature of the materials.

15. 222-224

Revise to read as follows:

“3. Once any errors are resolved, the sponsor should submit an adequate number of unredacted copies, or an electronic version, of its section(s) of the final Panel Pack for the panel and CDRH staff involved in the meeting. A redacted version should also be submitted for FDA Freedom of Information (FOI) review in accordance with 21 CFR Part 20.”

The redacted version of the panel pack should be provided with the final panel pack from the sponsor. Changes made during the ‘42 to 22 day’ review by CDRH could materially impact the redacted version of the panel pack, thus requiring revisions. Specific reference to the redacted version should be noted.

16. 225-229 This section should specify that CDRH’s questions to the Panel must be included in the Panel Pack and that they should not be revised after the Panel Pack is sent out.

The Sponsor will spend considerable effort ensuring its presentation addresses CDRH’s questions to the Panel. The Sponsor should have assurance that the questions are in the Panel Pack and that they will not be changed.

17. 227-229 Revise to read as follows:

“CDRH should send the final unredacted Panel Pack to the

Unredacted Panel Packs contain confidential and trade secret information. While no malicious intent is being considered as part of this comment, controlling the security

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panel members and the sponsor. Panel Packs may be provided electronically to the sponsor to facilitate timely dissemination of information.”

Also consider adding text that it is acceptable to provide the industry representative/ consumer representative with a redacted copy of the Panel Pack.

of electronic transmission/ dissemination of materials is more difficult.

18. 232-234

This section should specify when the final slides are provided, not just when draft slides are provided. This section should also specify how CDRH or the Sponsor will be able to modify their slides based on last-minute changes discovered in the final slides from either party. In addition, this section should reiterate that CDRH’s questions to the Panel cannot be changed after the Panel Pack is sent out.

Revise to read as follows:

“Two (2) full business days (or more) before the panel meeting, CDRH should post on the FDA website both the sponsor’s and CDRH’s redacted publicly available briefing materials to make them publicly available.

The day before the panel meeting, the sponsor and CDRH should exchange presentations by email.

On the day of the panel meeting, the sponsor and CDRH Division Director should discuss any differences in the presentations prior to the start of the panel meeting vs. the draft slides exchange.

The Sponsor should not be confronted with a situation where CDRH has changed its presentation or its questions to the Panel at the last minute, with no opportunity to react.

FDA should not release this information more than 2 business days before the meeting; this has the ability to impact the outcome of the meeting. Further, not having a consistent timeframe for release presents an unfair advantage/disadvantage for the sponsor involved.

This section also should identify the procedures for exchanging the presentation and discussing any final changes prior to the meeting. The additional procedures should include a two-way sharing of information between the Sponsor and CDRH, rather than just the Sponsor sharing with CDRH (which typically happens today). FDA should consider making this process more transparent and fair to the Sponsor.

19. 235-238

As described in the “Preparation and Public Availability of Information Given to advisory Committee Members” guidance, FDA’s Freedom of Information (FOI) staff should works interactively with the sponsor to ensure that the proper redactions are made prior to the panel pack being posted on FDA’s website.

This should not be optional.

20. 243 CDRH shall, during its opportunity to review the sponsor Panel Pack, attempt to identify any area of the sponsor presentation that it deems as new information or data

In a recent Panel mtg, the FDA came to the sponsor ten minutes before the meeting was to start and indicated that the sponsor needed to pull slides from their presentation or

ADVAMED COMMENTS Procedures for Meetings of the Medical Devices Advisory Committee; Draft Guidance for Industry and Food and Drug Administration Staff

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requiring the disclaimer that it has not been reviewed by the FDA.

add the disclaimer. The CDRH personnel then also announced during the meeting that it had not reviewed the data being presented formally and that the Panel should disregard the data being presented- It is believed this highly prejudiced the Panel against the testimony of the sponsor’s OUS data. If the FDA had come to the sponsor well in advance (during the 5 day review of the presentation period) this could have been avoided. It is believed this occurred because members of CDRH had not reviewed the sponsor presentation until within 24 hours of the meeting and thus did not have time to get their opinions to the lead reviewer to discuss with the sponsor until the morning of the meeting.

21. 253-255

…recommends that the Agency provide its briefing materials to the sponsor between 21 and 14 business days before the meeting, for Premarket Submission meetings, CDRH intends to provide the sponsor with its proposed materials earlier than that in order to allow additional time for sponsor input.

This information is in a footnote and should be brought into the section outlining the timeline of the days leading to the panel meeting. In our experience, CDRH typically does not share proposed materials earlier than at the point of ‘fact checking’. FDA should provide sections of their panel pack to the sponsor at the same timeframe as the sponsor is sharing a draft of their parts of the panel pack, approximately 42 business days before the panel meeting. As this document is a shared piece between CDRH and the Sponsor it is appropriate for both parties to have the same timeframe in which to review each other’s pieces. Therefore, this guidance should put more emphasis on CDRH’s pieces of the panel pack and make this something more than a footnote and an intention. (See Comment #13)

22. 258-262 Add that the Sponsor/industry material may also be included in the Panel Pack, if applicable.

For some regulatory issue meeting topics it may be appropriate to provide sponsor or industry materials. This should be acknowledged in this guidance document.

23. 280-285 A specific mechanism for how the Sponsor will be invited to respond to any differing views should be included.

The Sponsor needs a clear method for assuring it has “adequate time for response to any differing views” and should not have to depend on a specific request for input from a Panel member.

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24. 286-288

Revise to read as follows:

“…the sponsor should generally be provided 60 minutes (and up to 90 minutes if (1) the sponsor requests and the Panel Chair agrees…”

If the panel is to be independent, the Panel Chair will not have enough information on the issues at hand to make a decision on the length of the sponsor’s presentation. This should be FDA’s decision.

25. 303 Please define or provide examples of special circumstances Clarification.

26. 306-308

Revise to read as follows:

“Depending on the complexity of the regulatory issues being discussed, CDRH may opt to will conduct pre-meeting training for only the panel members (including any non-voting industry, consumer, or patient representatives) and sponsor representative.”

FDA should open the Panel training session to the Sponsor representative that will also be participating in the meeting. This may be limited to just 1 or 2 representatives. This training does not include information specific to any device being discussed in the open panel meeting, nor are there any deliberations on any issues being brought before the panel, so this would be helpful information to the sponsor as well. Further, the training materials are made publicly available so it is unclear why FDA conducts such pre-meeting training only for the panel members involved in the meeting.

27. 312

“…and typically will not include information specific to any device(s) being discussed…”

Consider removing “typically” or provide examples of when this may occur.

The panel process is intended to provide an independent transparent review so that they can advise FDA on issues at hand in an unbiased manner.

28. 315

Subject to the Freedom of Information Act, the training materials should will be provided to the sponsor in advance of the pre-meeting training and be made available for public inspection, unless sponsor confidential/trade secret information is included.”

Ensures independent panel and protects confidential information. Making these materials publicly available should be a consistent practice, if training was conducted.

Line 315 states training materials should be made available for public inspection, but to ensure that the sponsor has an opportunity to review the training materials for accuracy, it should be made available to them earlier.

29. 328-332 This section should state specifically how the Sponsor will be provided an equal opportunity to respond to questions from the panel members.

The Sponsor should not have to rely on a specific request for input from a panel member in order to speak during this period.

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30. 333-340

This section should include specifics about how the panel chair summarizes the panel’s answers and how the Sponsor will be allowed to comment on that summary. The section should also note other questions which CDRH typically asks the panel.

Revise to read as follows:

“Once the general panel deliberations are completed, CDRH should ask the specific questions to the panel. Additional input from interested parties, including a sponsor, will be allowed at the discretion of the Panel Chair. Each Panel Member should be asked to individually respond to each CDRH question. The Panel Chair’s role is to facilitate the questioning, not to summarize the opinions of the Panel. At the conclusion of each CDRH question, both CDRH and the affected person(s) including the Sponsor should be provided an equal opportunity to provide additional input at the discretion of the Panel Chair.”

The panel chair may provide an inaccurate or incomplete summary, which is entered into the minutes. The Sponsor should have an opportunity to correct the information or at least to provide comment, at the time the summary is provided.

CDRH typically asks the panel questions about postmarket requirements for the device, e.g., post-approval studies or registries. Other typical questions include appropriateness of indications, labeling, etc.

Recent experience is that Panel Chairs are inconsistently running the CDRH question period. In a recent panel, the Chair answered the CDRH questions himself by conjecturing the opinion of the panel. In another Panel meeting, each panel member was asked to respond to the CDRH questions. The Sponsor and CDRH should be given an equal opportunity to rebut new information often raised during the CDRH question period.

31. 340-341 The Sponsor should be allowed to make final remarks after the panel deliberations and before the voting.

If the Sponsor believes the panel has been biased by the questions or the manner in which their deliberations are summarized by the panel chair, this is the Sponsor’s opportunity to articulate an alternate viewpoint.

32. 342-343 FDA should clarify who “all voting members” are. Clarification.

33. 346-347

Revise to read as follows:

“A member should be considered present if he or she has participated in the full deliberations of the meeting by phone. A member who leaves the meeting prior to the vote should not be able to cast a vote.”

Line 346 contradicts Line 347, and the former should be deleted.

Line 346: “A member should be considered present if he or she has participated in the full deliberations of the meeting by phone.” In the case of a particular medical device Premarket Submission Meeting, telephone participation is not adequate since the person on the telephone would not be able to benefit from all audiovisual aids such as the use of pointers, etc. in describing the data.

Line 347: “All voting should be conducted in public view.” – This could be interpreted as conflicting with the sentence above re: participation via phone. It is unclear how the phone voting would be achieved, especially if electronic

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voting is used.

34. 365-367

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.

Clarification.

35. 343-374 Footnote 8 should be brought into the text.

It would be clearer if FDA were to identify how the voting questions would change for a 510(k) or HDE advisory committee meeting in the voting section of the guidance document. For example, for an HDE submission the panel is not voting on an efficacy question but rather probable benefit.

36. 383-387

Revise to read as follows:

“After voting, pPanel members should be asked to state how they answered each question and to explain their answers. After voting, The panel may discuss whether changes to labeling, restrictions on use, longer term follow-up, or other controls that may alter the benefit vs. risk calculus, in order to give the sponsor constructive feedback on their submission.”

Clarification.

37. 388-390

Revise to read as follows:

“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” or ‘abstain.’ A description of any remedial or mitigating studies or actions should be given.”

Clarification.

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38. 392-400

Revise to read as follows:

“For Premarket Submission panel meetings, the Indications for Use to be voted on should be the Indications for Use as described in the FDA Executive Summary in the Panel Pack provided by CDRH prior to the meeting (see Section 5.1 above). The FDA Executive Summary relies on what was submitted by the sponsor in the original submission, unless the submission was amended in a subsequent submission. Proposed changes or modifications to the Indications for Use 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 Indications for Use as stated in the FDA Executive Summary.”

This section should be clarified to acknowledge that it is the FDA Executive Summary that is being referenced here versus the Sponsor Executive Summary that is in the Panel Pack (although in practice, both the FDA and Sponsor Executive Summaries should state the same Indications for Use statement).

39. 403-408

Revise to read as follows:

“The members of the panel should be afforded an opportunity to explain their vote. After voting, the panel may will discuss whether a change in the Indications for Use could have an impact on the benefit vs. risk calculus. Such discussion should also include what additional pre- or post-market data or scientific information, if any, would be needed to pursue new Indications for Use.”

The panel should be encouraged to discuss whether a change in the indications for use could have an impact on the benefit vs. risk calculus. This is an important role in this process and valuable information for FDA and the sponsor to obtain. If this is left up to the discretion of the chair and is not a consistent element in an advisory committee panel meeting for premarket submissions, this is an unfair advantage/ disadvantage for the sponsor involved.

40. 428

Revise to read as follows:

“ . . . opportunity to provide statements to the panel as described in 6.21 and 6.3 above.

Corrected section reference.