Public Health Opportunity! Update FDA Medical Device Advisory Panel rules

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM440348.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Procedures for Meetings of the Medical Devices Advisory Committee 

Draft Guidance for Industry and 

Food and Drug Administration 

Staff 

DRAFT GUIDANCE 

This guidance document is being distributed for comment purposes only. Document issued on: April 1, 2015  FiDA Highlight Added

You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. 

For questions regarding this document, contact James Swink at 301-796-6313 or James.Swink@fda.hhs.gov. 

When final, this document will supersede Guidance on Amended Procedures for Advisory Panel Meetings, issued July 22, 2000, and Panel Review of Premarket Approval Applications #P91-2, issued May 3, 1991. 

U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Office of In Vitro Diagnostics and Radiological Health 

Preface 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. 

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Draft Guidance for Industry and Food and Drug Administration Staff 

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 

1 Introduction 

The Center for Devices and Radiological Health (CDRH) is issuing this draft guidance to provide additional 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. 

2 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

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. 

This guidance is intended to provide more comprehensive 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. Once final, this guidance will replace the Guidance on Amended Procedures for Advisory Panel Meetings (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u cm073722.htm) and the guidance document Panel Review of Premarket Approval Applications #P91-2 (blue book memo) (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u cm081363.htm). This guidance supplements existing FDA Agency-wide guidance on the conduct of advisory committee meetings. 

3 Scope 

As noted above, 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. 

4 Types of Panel Meeting Topics 

FDA may refer a matter to a panel for the following, with regard to medical device regulation: 

1. Advice on a Premarket Submission. Panels consisting of persons with expertise relevant to the medical device premarket submissions under review 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. When the Agency is not legally required to refer a particular submission to an advisory committee,3 CDRH intends to consider taking it before a panel if, in CDRH’s judgment, the submission is of significant public interest, the 

 submission is highly controversial, or there is a special type of expertise provided by the panel that could assist the Agency in its decision-making. See Draft Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125651.pdf). 

Scenarios in which CDRH may seek panel input include, but are not limited to: 

1. novel technology expected to have a significant impact on clinical
   practice;
   
2. 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
   
3. 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 submissions, including premarket notifications (510(k)s), de novo requests (de novo) and humanitarian device exemptions (HDEs). The panel’s recommendations are then considered as part of CDRH’s decision whether to allow marketing of the device. 

2. 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: 

o Classification/Reclassification. FDA is required by statute to seek a panel’s input as part of the classification of a preamendments device (see 513(c)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)) or as part of the process to reclassify such a device (see 513(e)(1)(A)(i) of the FD&C Act).4 

In addition, FDA may for good cause shown refer a petition requesting reclassification of a postamendments device to a panel under section 513(f)(3) of the FD&C Act, but is not required to do so. 

o 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 industry applicants 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 post market 

safety issues to a panel meeting for recommendations. As noted above, FDA intends to consider convening a panel meeting when a matter is of significant public interest, a matter is highly controversial, or there is a special type of expertise provided by the panel that could assist the Agency in its decision- making. 

Issues considered by the panels of the Medical Devices Advisory Committee are generally “particular matters” under 5 CFR 2640.103(a)(1). Thus, federal officers or 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. For more information on conflict of interest, please refer to FDA’s relevant guidance documents: 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) and Public Availability of Advisory Committee Members' Financial Interest Information and Waivers (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM295372.pdf). 

5 Exchange of Information for Panel Meetings 

The sections below describe the development and release of briefing materials prepared for the open portions of panel meetings, consistent with 5 U.S.C App. 2.5 For more information on briefing materials, please refer to 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). 

Panel meetings are scheduled based on the availability of necessary SGEs, FDA staff, sponsor6 staff, and an appropriate meeting venue. All panel meetings are announced in the Federal Register. 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 Federal Register notice. All panel-related questions should be relayed through the DFO listed in the Federal Register notice. 

5.1 Premarket Submission Meeting Topics 

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 sponsor a prepared panel package of briefing materials, referred to as the “Panel Pack,” which may include: 

1. FDA’s agenda;
   
2. FDA’s Executive Summary;
   
3. FDA’s questions for panel consideration;
   
4. Sponsor’s Executive Summary;
   
5. Appropriate sections or excerpts from the submission (i.e., relevant nonclinical
   and clinical data, draft summary of safety and effectiveness data, proposed
   labeling);
   
6. Any information deemed relevant by the FDA (e.g., publications/literature);
   
7. Related information submitted by the sponsor.
   

CDRH suggests the following timeline for interactions between the sponsor 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/non-releasable information, as contained in 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). 

1.   Approximately fifty-five (55) business days before the panel meeting: 

1. CDRH should send the sponsor an Advisory Committee information letter, including a draft outline of material that the Center intends to include in the Panel Pack.
   
2. CDRH should ask that the sponsor identify any additional information from the premarket submission, or other related information, they wish to be included in the Panel Pack.
   

1.   Approximately forty-two (42) business days before the panel meeting:
   The sponsor should submit two 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.
   
2.   Between forty-two (42) and twenty-two (22) business days before the panel meeting:
   

1. CDRH should assess the sponsor’s unredacted sections of the Panel Pack for completeness and relevance and provide any feedback regarding the proposed content to the sponsor by telephone or e-mail. 

1. CDRH and the sponsor should exchange and review for factual errors the information proposed by each party to be included in the Panel Pack.7
   
2. 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.
   

1.   Approximately twenty-one (21) to fourteen (14) business days before the panel meeting:
   CDRH should send the final unredacted Panel Pack to the panel members and the sponsor. Panel Packs may be provided electronically to facilitate timely dissemination of information.
   
2.   Approximately five (5) business days prior to the meeting, the sponsor and CDRH should exchange draft slides intended for presentation to the panel at the meeting.
   
3.   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 publicly available briefing materials.
   As described in the “Preparation and Public Availability of Information Given to Advisory Committee Members” guidance, FDA’s Freedom of Information (FOI) staff should work interactively with the sponsor to ensure that the proper redactions are made prior to the Panel Pack being posted on FDA’s website. New data and significant new analyses will not generally be reviewed by CDRH if they are received less than 12 weeks prior to a panel meeting. The Panel Pack and sponsor presentation should generally be limited to information that was included in the submission prior to this timeframe or agreed upon for inclusion by CDRH. In the limited circumstances in which a sponsor finds it necessary to include other data or analyses in the Panel Pack or in its presentation, the affected sections of the Panel Pack and each slide of the presentation containing such information should prominently note that the data or analysis, as appropriate, was not provided to CDRH prior to inclusion in the Panel Pack or sponsor presentation and, as such, has not been formally reviewed by
   CDRH. Sponsors are advised that the panel may or may not choose to consider such information in their deliberations.
   

5.2 Regulatory Issues Meeting Topics 

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: 

1. FDA’s agenda;
   
2. FDA’s Executive Summary; and
   
3. FDA’s questions for panel consideration.
   

Consistent with Guidance for Industry: Advisory Committee Meetings—Preparation and Public Availability of Information Given to Advisory Committee Members, 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. In addition, in advance of the panel meeting, CDRH should provide affected persons with relevant portions of any briefing materials that (in our determination) contain information that, under certain circumstances, could be considered to be confidential commercial or trade secret information. Any interested parties wishing to comment on the issues for panel discussion may request time to speak during the open public hearing session of the panel meeting (see section 6.2 below). 

6 Conduct of Panel Meetings 

CDRH intends to conduct Medical Device Advisory Committee panel meetings consistent with the requirements of the Federal Advisory Committee Act (FACA), other relevant statutes (e.g., the FD&C Act), regulations (e.g., 21 CFR 14.25, 14.29), and Agency guidance and policies. The order of discussion of the presentations below does not necessarily reflect the order of presentation at an advisory panel meeting. 

6.1 Medical Device Industry Presentations 

Under Section 513(b)(6)(A)(iii) of the 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.” Further, Section 513(b)(6)(B) of the FD&C Act requires that: (1) adequate time be provided for initial presentations; (2) adequate time be provided for response to any differing views by persons whose devices are specifically the subject of panel; and (3) free and open participation by all interested persons be encouraged. For Premarket Submission panel meeting topics, the sponsor should generally be provided 60 minutes (and up to 90 minutes if (1) the sponsor requests and the Panel Chair agrees that additional time is needed, or (2) the CDRH presentation is 90 minutes) to present information to the panel. 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 apply. However, the time slot 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 Chairperson. 

6.2 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 special circumstances). FDA’s slides typically present the Agency’s scientific and/or regulatory view of the issues at hand and ask for specific guidance 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 only 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 typically will not include information specific to any device(s) being discussed in the open panel meeting. The panel should not deliberate on any issue being brought before the panel at this time nor provide any advice to the Center. Subject to the Freedom of Information Act, the training materials should be made available for public inspection. 

6.3 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 (21 CFR 14.25(a)). 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 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). 

6.4 Panel Deliberations and CDRH Questions 

There should be approximately one 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. 

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. 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. 

6.5 Panel Voting 

The Voting Procedures for panel meetings are described in 21 CFR 14.22(d), and matters are to be considered by all voting members present at the time. There are no provisions for absentee voting, proxy voting, or any voting method other than voting by those present and attending the meeting. 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. 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. For more information on voting procedures, please refer to Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125641.pdf). 

6.5.1 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. 

6.5.2 Voting Procedure for Premarket Submission Panel Meetings Regarding PMA Applications8 

The panel is typically expected 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 completing the panel deliberations and after answering discussion questions as explained in Section 6.4 of this guidance, CDRH intends to ask panel members to vote by open ballot or via electronic voting, and each vote 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 benefits of X device for indication(s) A (and B, etc.) outweigh the risks of device X for indication(s) A (and B, etc.)? 

Panel 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. 

If the evidence provided is insufficient to allow for any of the determinations, the panel member should state this as the reason for answering “no.” A description of any remedial or mitigating studies or actions should be given. 

6.5.3 Indications for Use and Voting 

For Premarket Submission panel meetings, the Indications for Use to be voted on should be the Indications for Use as described in the Executive Summary in the Panel Pack provided by CDRH prior to the meeting (see Section 5.1 above). The 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 Executive Summary. If the original Indications for Use presented to the panel receives an unfavorable vote, a different Indications for Use may also be considered by the panel, at the discretion of the Panel Chair, with input from the sponsor, and upon concurrence from the CDRH representative. 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 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. 

6.6 Teleconference Panel Meetings 

Panel meetings may be held by conference telephone call as provided for in 21 CFR 14.22(g). 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 open 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 at a conference room located in Washington, DC, or Rockville, MD, or the immediate vicinity, and should be afforded the opportunity to provide statements to the panel as described in 6.2 and 6.3 above. 

1 For more information about the procedures of the Medical Devices Dispute Resolution Panel, see Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm284651.htm#s3)

 2 The Medical Devices Advisory Committee is comprised of the following advisory panels: 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 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.

3 FDA is required by statute to take a complete premarket approval (PMA) application and a proposed product development protocol (PDP) to a panel upon the request of a submitter, unless FDA finds that the information submitted substantially duplicates information which has previously been reviewed by a panel. See FD&C Act § 515(c)(3)(B) & (f)(2)(B), 21 U.S.C. § 360e(c)(3)(B) & (f)(2)(B). 

4 FDA is also required to seek panel input as part of an action to call for PMAs for a preamendments class III device. See FD&C Act § 515(b)(1), 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. 

5 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.
6 For purposes of this guidance, “sponsor” refers to a party who submits a premarket submission that is the subject of a Premarket Submission panel meeting—for example, the 510(k) submitter or the PMA applicant. 

7 Although the Agency-wide guidance (“Preparation and Public Availability of Information Given to Advisory Committee Members”) 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. 

8 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.

7 References 

1.   Medical Devices Advisory Committee, Information and Materials: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/ default.htm
   

1.   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
   
2.   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
   
3.   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
   
4.   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
   
5.   Voting Procedures: Guidance for FDA Advisory Committee Members adn FDA Staff: Voting Procedures at Advisory Committee Meetings http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125641.pdf
   
6.   Criteria for Panel Meetings: Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings - Draft http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125651.pdf
   
7.   Dispute Resolution Panel: Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument s/ucm284651.htm#s3
   

Astroturf Lobby Group? Where is the Patient Engagement?

Greetings,

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration would like to make you aware of an upcoming event. Next Monday the independent non-profit Medical Device Innovation Consortium (MDIC) will be announcing a new public-private partnership between the MDIC, FDA, other government agencies, non-profits, academia, and the medical device industry designed to address emerging device regulatory science issues.  Additional information on the MDIC can be found at http://www.deviceconsortium.org/

As key health technology stakeholders, we would be pleased for you to join us to hear the Commissioner discuss this important new initiative. The Consortium is designed to improve outcomes for patients by fostering innovation, increasing the tools available to evaluate new medical devices to make sure they are safe and effective, and to ensure these improvements in care get to patients as expeditiously as possibly while safeguarding public health.

Please join us if you can,

Michelle McMurry-Heath

Associate Director for Science, Acting Chief Scientist

Office of the Center Director

Center for Devices and Radiological Health

U.S. Food and Drug Administration

---------------------------------------------------------

You are invited to attend the Senate MedTech Caucus briefing:

Monday, December 3rd, 10:30 am – 12:00 pm

Room 106, Dirksen Senate Office Building

Announcing: “Medical Device Innovation Consortium”

Featuring: FDA Commissioner, Margaret Hamburg, M.D. & FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.

The program will include a briefing on the creation of the Medical Device Innovation Consortium (MDIC).

The MDIC is a Public-Private Partnership (PPP) whose mission is to improve health through the application of shared knowledge in medical device regulatory science.  It is the first-ever PPP created to focus exclusively on advancing medical device regulatory science.

The MDIC will create a collaborative environment where nationwide representatives from industry, non-profits, and FDA can work together to keep pace with the needs of patients in the United States.

Speakers will include:

Senator Amy Klobuchar

Senator Al Franken

FDA Commissioner, Margaret Hamburg, M.D.

FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.

Centers for Medicare & Medicaid Services, Deputy Director, Coverage & Analysis Group, Tamara Syrek Jensen, J.D.

Immucor, Inc., CEO, William Hawkins

LifeScience Alley CEO, Dale Wahlstrom

http://www.deviceconsortium.org

The Medical Device Innovation Consortium is a public private partnership whose mission is to improve health through the application of shared knowledge in regulatory science.

Focused on the Medical Device Industry

The MDIC is the only public private partnership focused exclusively on the strategic needs of the medical device industry. The MDIC is designed to create a collaborative environment where the private sector can partner with the FDA’s Center for Devices and Radiological Health to solve technical issues that affect the industry.

Focused on Regulatory Science

Regulatory science refers to the development and evaluation of new tools, methods, standards and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle.

Focused on Improving Health

The MDIC has been formed to add value at the intersecting needs of the medical device industry, the FDA, and the related organizations that are together responsible for a vibrant medical device industry that serves the public health needs of the U.S.

Founding Members

FDA

Medtronic

Life Science Alley

About Us

The MDIC is the first ever Public Private Partnership (PPP) created with the sole objective of advancing medical device regulatory science. The intent is to be a national 501c(3) organization that operates in partnership with the FDA.

•                The PPP relationship was formalized with the signing of a Memorandum of Understanding between LifeScience Alley, Inc., a Minnesota trade association, and the FDA on December 7, 2011. In August 2012, Articles of Incorporation were filed to formally establish the MDIC.

•                Membership and participation in the MDIC will be open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, or education; the promotion of public health; or who have expertise in regulatory science.

Governance Structure

The MDIC will be governed by a Board of Directors that will oversee the MDIC’s subcommittees and assist in identifying sources of funding. Subcommittees will represent industry sectors or technology areas (eg. Modeling, interoperability, orthopedics, neurological devices).

•                Each subcommittee will be responsible for establishing working groups chartered with identifying key issues affecting their industry segment.

•                The working groups will bring forward project plans for prioritization and funding allocation.

What We Do

Strategies

The MDIC will pursue several strategies in support of its mission:

1.            Create a forum for collaboration and dialogue, working within a flexible governance structure to encourage broad participation from the different industry stakeholders including FDA.

2.            Make strategic investments in regulatory science, utilizing working groups to identify and prioritize key issues and to request, evaluate, and implement project proposals that support the MDIC’s mission.

3.            Provide tools to drive cost effective innovation, emphasizing education and the development of new methods and approaches with well documented data and details to enable implementation.

Value

The activities and output from the MDIC will:

•                Ensure innovative technology is readily available to U.S. patients

•                Make the medical device regulatory process more expeditious, transparent and effective

•                Reduce the risk and expense of clinical research

•                Reduce the time and cost of medical device development

Projects

The MDIC will accept project proposals specifically focused on advancing medical device regulatory science.

After the initial meeting of the MDIC Board of Directors (early in CY13), the first sector subcommittees will be commissioned.

•                The subcommittees will organize working groups to develop rigorous project plans for prioritized topics.

•                Detailed project plans will be used to solicit project specific funding from companies who will benefit from their outcome and foundations interested in supporting the initiative.

The advantages of conducting research within the MDIC include:

•                Involvement of the FDA at all stages of the work thereby building awareness of and support for specific product development tools and approaches.

•                The ability to share best practices across industry and academia.

•                Exposure to a range of perspectives representing multiple constituents which can ensure more robust project development and data interpretation.

•                A mechanism for sharing the expense of research in the regulatory science, non-competitive domain.

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Join

The core operations of the MDIC are funded through contributions from members.

•                Pricing for annual membership is determined based upon the operating expenses for the MDIC.

•                The goal is to keep the membership low enough to encourage broad, cross-industry participation while still meeting the operational needs of the organization.

•                It is anticipated that as the membership base is increased, there is the potential that the dues per member will decrease.

Membership will be offered at several levels based on organization type and, if applicable, annual revenue. Project specific funding will be obtained from companies and foundations as a result of working group development of rigorous project plans.

•                $150,000 contribution annually: Companies with annual revenue >$10 B

•                $100,000 contribution annually: Companies with annual revenue between $5–10 B

•                $50,000 contribution annually: Companies with annual revenue between $1–4.9 B

•                $10,000 contribution annually: Companies with annual revenue <$1 B

•                $5,000 contribution annually: Nonprofit Sector

Benefits of Membership

The MDIC will provide its members with:

•                A mechanism through which to influence the future of the medical device industry by virtue of direct, collaborative discussions and projects with FDA.

•                A process for identifying, documenting, prioritizing and removing issues affecting the industry.

•                Processes, policies, support staff and pooled project funding to enable efficient regulatory science research in areas of strategic importance to the industry.

•                Educational forums in which to learn about the evolving regulatory science process, new tools, standards and test methods.

•                Searchable databases and links to relevant reports and methods.

•                Regular updates on the status of the MDIC’s activities and opportunities for involvement.

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Contact Us

To receive further information and to discuss next steps and membership details, please contact:

Maura Donovan, Ph.D.
Interim Executive Director, MDIC
763-505-4515
maura.donovan@medtronic.com

or

Dale Wahlstrom
CEO of LifeScience Alley
952-542-3077
dwahlstrom@biobusinessalliance.org

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Press

Minnesota Device-Makers Join Forces with FDA to Advance Regulatory Science

Regulatory Intelligence | Posted: 8 December 2011

Minnesota-based medical device lobbying group, LifeScience Alley, signed a memorandum of understanding with the US Food and Drug Administration (FDA), making official a year-long partnership to continue developing best practices in regulatory science. Center for Devices & Radiological health chief Dr. Jeffrey Shuren signed the memorandum, formalizing more than a year of joint effort toward developing regulatory science — a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices. If the pilot version of the program works in Minnesota, it may serve as a national model for device safety and clearance. (Mass Device)

Join the discussion on Regulatory Exchange

http://www.massbio.org/news/181-sen_brown_co-chairs_medical_technology_caucus/news_detail

Sen. Brown co-chairs Medical Technology Caucus

April 4, 2011

WASHINGTON, DC— U.S. Senators Scott Brown (R-MA) and Amy Klobuchar (D-MN) announced today that they will serve as co-chairs for the new Senate Medical Technology Caucus in the 112^th Congress. The caucus aims to increase awareness about issues facing the medical technology sector, an industry that creates life-saving and life-enhancing innovations that improve patient care.

“In Massachusetts, we have more than 200 medical device companies and hundreds of bio and pharma companies, all of which provide good-paying jobs to thousands of citizens,” Brown said. “It is critical that we provide a business environment for them to innovate, grow and thrive. I’m pleased to be the Republican chair of this bipartisan caucus, and look forward to working with my colleagues on both sides of the aisle to give our medical device and technology companies the tools and resources they need to continue their important work.”

“These businesses not only spark medical breakthroughs, they save lives,” Klobuchar said. “Every day in every state small medical technology companies are driving the innovation agenda we need to compete in a global economy. I will continue to work to make sure that Minnesota remains a leader in health care innovation by developing innovative products while maintaining patient safety.”

The United States is the world’s only net exporter of medical devices, with a $5.4-billion annual trade surplus. Minnesota is home to 400 medical device practices that support over 50,000 jobs in the state. The industry provides good-paying jobs to more than 400,000 Americans, with total direct and indirect employment exceeding two million.

Klobuchar has led the effort to cut red tape that threatens innovation in this industry. After a December report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar and Brown pushed the Food and Drug Administration (FDA) to reform its slow and inconsistent 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and plans to hold a hearing to examine the medical device approval process and to examine ways to improve export options.