    [House Hearing, 115 Congress]
    [From the U.S. Government Publishing Office]

                EXAMINING FDA'S MEDICAL DEVICE USER FEE PROGRAM

    =======================================================================

                                    HEARING

                                   BEFORE THE

                             SUBCOMMITTEE ON HEALTH

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                         ONE HUNDRED FIFTEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                 MARCH 28, 2017

                                   __________

                               Serial No. 115-20

     [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

          Printed for the use of the Committee on Energy and Commerce

                            energycommerce.house.gov

                               _________

                     U.S. GOVERNMENT PUBLISHING OFFICE

     25-747 PDF             WASHINGTON : 2018

                        COMMITTEE ON ENERGY AND COMMERCE

                              GREG WALDEN, Oregon
                                     Chairman

    JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
      Vice Chairman                        Ranking Member
    FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
    JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
    TIM MURPHY, Pennsylvania             ELIOT L. ENGEL, New York
    MICHAEL C. BURGESS, Texas            GENE GREEN, Texas
    MARSHA BLACKBURN, Tennessee          DIANA DeGETTE, Colorado
    STEVE SCALISE, Louisiana             MICHAEL F. DOYLE, Pennsylvania
    ROBERT E. LATTA, Ohio                JANICE D. SCHAKOWSKY, Illinois
    CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
    GREGG HARPER, Mississippi            DORIS O. MATSUI, California
    LEONARD LANCE, New Jersey            KATHY CASTOR, Florida
    BRETT GUTHRIE, Kentucky              JOHN P. SARBANES, Maryland
    PETE OLSON, Texas                    JERRY McNERNEY, California
    DAVID B. McKINLEY, West Virginia     PETER WELCH, Vermont
    ADAM KINZINGER, Illinois             BEN RAY LUJAN, New Mexico
    H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
    GUS M. BILIRAKIS, Florida            YVETTE D. CLARKE, New York
    BILL JOHNSON, Ohio                   DAVID LOEBSACK, Iowa
    BILLY LONG, Missouri                 KURT SCHRADER, Oregon
    LARRY BUCSHON, Indiana               JOSEPH P. KENNEDY, III,
    BILL FLORES, Texas                   Massachusetts
    SUSAN W. BROOKS, Indiana             TONY CARDENAS, California
    MARKWAYNE MULLIN, Oklahoma           RAUL RUIZ, California
    RICHARD HUDSON, North Carolina       SCOTT H. PETERS, California
    CHRIS COLLINS, New York              DEBBIE DINGELL, Michigan
    KEVIN CRAMER, North Dakota
    TIM WALBERG, Michigan
    MIMI WALTERS, California
    RYAN A. COSTELLO, Pennsylvania
    EARL L. ``BUDDY'' CARTER, Georgia

                             Subcommittee on Health

                           MICHAEL C. BURGESS, Texas
                                     Chairman
    BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
      Vice Chairman                        Ranking Member
    JOE BARTON, Texas                    ELIOT L. ENGEL, New York
    FRED UPTON, Michigan                 JANICE D. SCHAKOWSKY, Illinois
    JOHN SHIMKUS, Illinois               G.K. BUTTERFIELD, North Carolina
    TIM MURPHY, Pennsylvania             DORIS O. MATSUI, California
    MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
    CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
    LEONARD LANCE, New Jersey            BEN RAY LUJAN, New Mexico
    H. MORGAN GRIFFITH, Virginia         KURT SCHRADER, Oregon
    GUS M. BILIRAKIS, Florida            JOSEPH P. KENNEDY, III,
    BILLY LONG, Missouri                     Massachusetts
    LARRY BUCSHON, Indiana               TONY CARDENAS, California
    SUSAN W. BROOKS, Indiana             ANNA G. ESHOO, California
    MARKWAYNE MULLIN, Oklahoma           DIANA DeGETTE, Colorado
    RICHARD HUDSON, North Carolina       FRANK PALLONE, Jr., New Jersey (ex
    CHRIS COLLINS, New York                  officio)
    EARL L. ``BUDDY'' CARTER, Georgia
    GREG WALDEN, Oregon (ex officio)

                                      (ii)

                                 C O N T E N T S

                                  ----------
                                                                       Page
    Hon. Michael C. Burgess, a Representative in Congress from the
      State of Texas, opening statement..............................     1
        Prepared statement...........................................     3
    Hon. Gene Green, a Representative in Congress from the State of
      Texas, opening statement.......................................     4
    Hon. Greg Walden, a Representative in Congress from the State of
      Oregon, opening statement......................................     5
        Prepared statement...........................................     6
    Hon. Frank Pallone, Jr., a Representative in Congress from the
      State of New Jersey, opening statement.........................     7
        Prepared statement...........................................     8

                                   Witnesses

    Jeffrey Shuren, M.D., Director, Center for Devices and
      Radiological Health, Food and Drug Administration, Department
      of Health and Human Services...................................     9
        Prepared statement...........................................    11
        Answers to submitted questions \1\...........................    97
    Cynthia A. Bens, Vice President of Public Policy, Alliance for
      Aging Research.................................................    55
        Prepared statement...........................................    58
        Answers to submitted questions \1\...........................   102
    Robert Kieval, Founder and Chief Executive Officer, CVRx.........    66
        Prepared statement...........................................    68
    Patrick Daly, President and Chief Executive Officer, Cohera
      Medical........................................................    74
        Prepared statement...........................................    76
        Answers to submitted questions \1\...........................   105
    Diane Wurzburger, Executive of Regulatory Affairs, GE Healthcare,
      on Behalf of the Medical Imaging & Technology Alliance.........    81
        Prepared statement...........................................    83

    ----------
    \1\ Dr. Shuren, Ms. Bens, and Mr. Daly did not answer submitted
      questions for the record by the time of printing.

                EXAMINING FDA'S MEDICAL DEVICE USER FEE PROGRAM

                                  ----------

                            TUESDAY, MARCH 28, 2017

                      House of Representatives,
                                Subcommittee on Health,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 10:15 a.m., in
    Room 2123 Rayburn House Office Building, Hon. Michael Burgess
    (chairman of the subcommittee) presiding.
        Members present: Representatives Burgess, Guthrie, Upton,
    Shimkus, Murphy, Blackburn, Lance, Griffith, Bilirakis, Long,
    Bucshon, Brooks, Mullin, Hudson, Collins, Carter, Walden (ex
    officio), Green, Schakowsky, Butterfield, Matsui, Castor,
    Schrader, Kennedy, Eshoo, DeGette, and Pallone (ex officio).
        Staff present: Zachary Dareshori, Staff Assistant; Jordan
    Davis, Director of Policy and External Affairs; Paul Edattel,
    Chief Counsel, Health; Adam Fromm, Director of Outreach and
    Coalitions; Jay Gulshen, Legislative Clerk, Health; Katie
    McKeough, Press Assistant; Carly McWilliams, Professional Staff
    Member, Health; Jennifer Sherman, Press Secretary; John Stone,
    Senior Counsel, Health; Hamlin Wade, Special Advisor for
    External Affairs; Jeff Carroll, Minority Staff Director;
    Tiffany Guarascio, Minority Deputy Staff Director and Chief
    Health Advisor; Dan Miller, Minority Staff Assistant; Olivia
    Pham, Minority Health Fellow; Samantha Satchell, Minority
    Policy Analyst; Kimberlee Trzeciak, Minority Health Policy
    Advisor; and C.J. Young, Minority Press Secretary.

    OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
                  IN CONGRESS FROM THE STATE OF TEXAS

        Mr. Burgess. The Subcommittee on Health will now come to
    order.
        The Chair starts by recognizing himself for 5 minutes for
    the purpose of an opening statement.
        Dr. Shuren, welcome back to our subcommittee. I am glad to
    say that your center at the Food and Drug Administration
    certainly, since 2012, I just have to acknowledge that there
    has been a--you have come a long way since the User Fee
    Agreement authorization from 2012.
        Today is this subcommittee's third hearing to consider the
    reauthorization of the Food and Drug Administration User Fee
    Programs that are set to expire in September. The Medical
    Device User Fee Agreement gives the Food and Drug
    Administration the authority to collect fees from the medical
    device industry and to support product review activities. This
    must be renewed every 5 years. The Energy and Commerce
    Committee has taken the necessary actions to renew this
    authority three times before, and this committee remains
    dedicated to completing this fourth authorization in a timely
    manner.
        While there can always be room for improvement, the Medical
    Device User Fee Agreements Program has significantly enhanced
    the efficiency, the transparency, and the uniformity of the
    product review process at the Food and Drug Administration.
    Leading up to the 2012 reauthorization of the Medical Device
    Agreements, this subcommittee heard repeatedly about the
    sometimes slow, sometimes onerous, sometimes arbitrary process
    by which devices were reviewed at the Center for Devices and
    Radiological Health. The state of affairs at the Center for
    Devices was driving away investment in research and development
    and significantly hindering the pace at which American patients
    had access to new medical technologies. Through the Food and
    Drug Administration Safety and Innovation Act, Congress
    reauthorized the Medical Device User Fee Agreements, and the
    paradigm started to shift in what I consider to be the right
    direction.
        The Food and Drug Administration Safety and Innovation Act
    included meaningful regulatory reforms, improved communication
    between the industry and the Food and Drug Administration, and
    increased accountability at the Centers for Devices and
    Radiological Health. It is important that the next Medical
    Device User Fee Agreement continue to build upon the progress
    that was made in the last FDA reauthorization bill as well as
    the good policies that members of this subcommittee championed
    during the discussions on the 21st Century Cures Act.
        I am encouraged that the proposed agreement transmitted to
    Congress in January contains many promising elements that will
    be good for the Food and Drug Administration, good for the
    industry, but, most importantly, good for our patients. In the
    proposed agreement, the Food and Drug Administration has agreed
    to further decrease the total time it takes from submission of
    an application to a final decision on approval. This is a good
    thing because it will get safe and effective products to
    doctors and to patients faster.
        Further, the Food and Drug Administration would enhance
    patient engagement by more formally involving patient
    preference and patient-reported outcomes in the review process.
    It is vital that the Food and Drug Administration routinely
    incorporate the patient perspective in its decisionmaking
    process.
        The proposed agreement would also establish process
    improvements and goals that ought to foster a more timely and
    efficient approval process if implemented. For instance, the
    process for pre-submission and interactions between the Food
    and Drug Administration and the industry would be updated and
    improved upon. In addition, the proposed agreement would
    establish a pilot program to examine the use of real-world
    evidence for pre-market activities.
        Furthermore, the proposed agreement provides for improved
    transparency and for greater responsibility. A wide array of
    new measures, new tools, and reports will provide data that is
    necessary to ensure that the Food and Drug Administration is
    meeting the goals of the agreement. Reauthorizing the Medical
    Device User Fee Agreements and the user fee programs we have
    previously discussed would increase efficiency at FDA and
    ensure that American patients benefit from advances in
    biomedical technology, that American patients benefit from
    advances and innovations as soon as safely possible.
        I want to thank all of our witnesses for being here today
    on both panels. I look forward to hearing from each of you
    about how the substance of the proposed User Fee Agreement will
    accomplish its stated goal.
        [The prepared statement of Mr. Burgess follows:]

                 Prepared statement of Hon. Michael C. Burgess

        The subcommittee will come to order.
        The Chair will recognize himself for an opening statement.
        Dr. Shuren, welcome back to our subcommittee. I am glad to
    say that your Center at FDA has come a long way since the 2012
    reauthorization of the Medical Device User Fee Amendments
    (MDUFA).
        Today is this subcommittee's third hearing to consider the
    reauthorization of FDA user fee programs set to expire in
    September. MDUFA gives FDA authority to collect fees from the
    medical device industry to support product review activities,
    and must be renewed every 5 years. The Energy and Commerce
    Committee has taken the necessary actions to renew this
    authority three times before, and this committee remains
    dedicated to completing this fourth authorization in a timely
    manner.
        While there will always be room for improvement, the MDUFA
    program has significantly enhanced the efficiency,
    transparency, and uniformity of the product review process at
    FDA. Leading up to the 2012 reauthorization of MDUFA, this
    subcommittee heard repeatedly about the slow, onerous, and
    arbitrary process by which devices were reviewed at the Center
    for Devices and Radiological Health (CDRH).
        The state of affairs at CDRH was driving away investment in
    research and development, and significantly hindering the pace
    at which American patients had access to new medical
    technologies. Through the Food and Drug Administration Safety
    and Innovation Act (FDASIA) Congress reauthorized MDUFA and the
    paradigm started to shift in the right direction.
        FDASIA included meaningful regulatory reforms, improved
    communication between industry and FDA, and increased
    accountability at CDRH. It is important that the next medical
    device user fee agreement continue to build upon the progress
    made in FDASIA, as well as the good policies members of this
    subcommittee championed in the 21st Century Cures Act. I am
    encouraged that the proposed agreement transmitted to Congress
    in January contains many promising elements that will be good
    for FDA, industry, and most importantly, patients.
        In the proposed agreement, FDA has agreed to further
    decrease the total amount of time it takes from submission of
    an application to a final decision on approval. This is a good
    thing because it will get safe and effective products to
    doctors and patients faster.
        Further, FDA would enhance patient engagement by more
    formally involving patient preference and patient reported
    outcomes in the review process. It is vital that FDA routinely
    incorporate the patient perspective in its decision-making
    process.
        The proposed agreement would also establish process
    improvements and goals that ought to foster a more timely and
    efficient approval process if implemented. For instance, the
    process for pre-submission interactions between FDA and
    industry would be updated and improved upon. In addition, the
    proposed agreement would establish a pilot program to examine
    the use of real-world evidence for premarket activities.
        Furthermore, the proposed agreement provides for improved
    transparency and greater responsibility. A wide array of new
    measures, tools, and reports will provide data that is
    necessary to ensure FDA is meeting the goals of the agreement.
        Reauthorizing MDUFA and the user fee programs we have
    previously discussed would increase efficiency at FDA and
    ensure that American patients benefit from advances in
    biomedical technology and innovation as soon as safely
    possible.
        I thank all of our witnesses for being here, and I look
    forward to hearing from each of you about how the substance of
    the proposed agreement will accomplish this goal.

        Mr. Burgess. It is now my pleasure to recognize the ranking
    member of the subcommittee, Mr. Gene Green of Texas, for 5
    minutes for the purpose of an opening statement.

       OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
                    CONGRESS FROM THE STATE OF TEXAS

        Mr. Green. Thank you, Mr. Chairman, and thank Dr. Shuren
    and our other witnesses for being here this morning.
        Modeled after the successful Prescription Drug User Fee
    Agreement, the Medical Device User Fee Agreement was first
    established in 2002. It authorizes the FDA to collect fees from
    medical device manufacturers to support the work of reviewing
    device applications and other components of medical device
    oversight.
        We are here today to learn about the fourth iteration of
    the Medical Device User Fee Agreement, or as we call it, PDUFA.
    This, similar to other user fee agreements, is an important
    tool to help ensure that the FDA can evaluate devices
    efficiently while upholding its gold standard of approval.
        Today is markedly different from where we were 5 years ago.
    There was widespread frustration with the program and the
    challenges facing the FDA. Medical device companies, and
    patients were in need. Thanks to investments provided by the
    industry, congressional leadership, and a commitment from the
    agency to double-down and address inadequacies head-on,
    substantial progress has been made.
        From 2009 to 2015, the time it takes for the FDA to issue a
    decision on PMA is down by 35 percent and down by 11 percent
    for 510(k) submissions. Critically, this has happened without
    any sacrifice in the FDA's gold standard for safety and
    effectiveness.
        And I want to thank Dr. Shuren for his leadership in
    changing the culture and policies and the processes of the
    Center for Devices and Radiological Health. This along with
    user fee funds and reforms instituted by Congress have resulted
    in an improved medical device pipeline, most importantly,
    innovative device technologies reaching patients in the United
    States earlier than in the past.
        Progress made since MDUFA III demonstrates the importance
    of user free programs and underscores how critical it is that
    Congress reauthorize the program without delay. We also
    recognize that more work remains to improve the innovation and
    ecosystem and realize the full potential of scientific
    breakthroughs, so patients can access new cures and treatments.
    Past efforts, combined with the provisions of this new User Fee
    Agreement, will keep things headed in the right direction.
        Measuring the total time for submission to an FDA decision
    on an application is a central measure of the user fee process.
    The MDUFA IV agreement would continue to drive towards reducing
    the total time that is spent reviewing submissions which brings
    innovator companies additional certainty and ensures
    breakthroughs get from the lab table to the bedside in a timely
    manner.
        The agreement also includes provisions to further enhance
    the predictability and efficiency of the review process. These
    provisions lay the groundwork for further performance
    improvements and advances in patient safety.
        MDUFA IV includes a new Quality Management Program to
    improve consistency and predictability in the review process.
    It will allow the FDA to strengthen partnership with patients
    to make sure that the patient remains at the center of the
    develop and review consideration.
        MDUFA IV will help get the National Evaluation System for
    Health Technology, or NEST, off the ground. Harnessing real-
    world data collected during the routine care, NEST has the
    potential to shorten the time and lower the cost it takes to
    bring a new device to market, expand approved uses for products
    already in the market, and meet post-market reporting
    requirements. Critically, NEST will enable faster
    identification of safety issues. This will allow the FDA to be
    more proactive in addressing safety concerns, which will reduce
    harm to patients and liability for companies.
        21st Century Cures included a number of improvements to the
    medical device pre- and post-market review processes. I am
    pleased, as agreement builds on past User Fee Agreements and
    reforms included in Cures, it maintains our shared commitment
    to ensuring patients benefit from innovative, safe devices
    necessary for public health and fostering a robust pipeline of
    new treatments and cures.
        The MDUFA IV agreement is supported by a broad range of
    stakeholders and is a result of extensive public input and
    review during the drafting process. It will expedite the
    availability of innovative products and continue to increase
    the efficiency of FDA. In short, this agreement is good for the
    medical device industry, healthcare providers, the FDA, and,
    most importantly, good for patients.
        I want to thank the FDA and the industry and patient
    advocates and providers and other stakeholders for their work
    on this agreement.
        And I want to thank again our witnesses for being here
    today. I look forward to your testimony and response to our
    committee's question.
        I yield back my time.
        Mr. Burgess. The Chair thanks the gentleman. The gentleman
    yields back.
         The Chair now is pleased to recognize the chairman of the
    full committee, Mr. Greg Walden from Oregon, 5 minutes for your
    opening statement, please.

      OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF OREGON

        Mr. Walden. Thank you, Chairman Burgess, for your work on
    this and many other issues.
        I want to welcome all of our witnesses. I have read through
    your testimony. It is most helpful as we work on this matter.
        The last time Congress reauthorized Medical Device User Fee
    Amendments, MDUFA, in 2012, we heard story after story about
    venture capital drying up, innovation, medical technology
    companies launching their products overseas. We heard
    oftentimes years before American patients could benefit from
    them.
        Witnesses from all sides of the political spectrum came
    before the subcommittee. They highlighted the burdensome,
    inconsistent, and opaque nature of the FDA review process as
    the primary driver for these alarming trends. That was 2012.
    What a difference 5 years makes.
        Thanks to Dr. Burgess and others, the Food and Drug
    Administration Safety and Innovation Act included a number of
    common-sense regulatory improvements that greatly benefitted
    patients and have spurred innovation.
        I would like to specifically thank Dr. Jeff Shuren who is
    with us today. Thank you for your leadership. You have done
    great work.
        All the legislation in the world could not change the
    deeply rooted cultural issues that were plaguing the Device
    Center at FDA. Dr. Shuren, you took constructive feedback to
    heart. You put these new legislative authorities to work and
    you got results for the American people.
        Since 2009, the number of innovative devices approved by
    the FDA has almost quadrupled, resulting in American patients
    benefitting from safe and effective American technologies
    sooner. In 2009, it took an average of 427 days before the FDA
    even reached the decision on a Pre-market Approval Application,
    a PMA. As of 2015, the average review time was down to 276
    days. That is a 25-percent decrease.
        More work lies ahead, but great strides have been made.
    Building upon the successful implementation of the previous
    User Free Agreement, 21st Century Cures legislation, heralded
    through this process by my friend from Michigan, Mr. Upton, and
    others, that also included a number of additional bipartisan
    process reforms reauthorizing MDUFA in a timely fashion, which
    I remain steadfastly committed to doing. It will ensure that we
    continue to move in the right direction.
        Today's hearing continues these positive efforts. This is a
    good agreement that will build upon some recent successes and
    strengthen the agency, improve the lives of patients, and
    bolster America's medical technology sector, which has brought
    hundreds of thousands of high-paying jobs to our communities.
    It is also a critical next step after the game-changing 21st
    Century Cures Act became law just a few months ago. So, let's
    continue to build upon these remarkable and bipartisan
    advancements that put patients first.
        Thank you again for the hard work that has gone into this
    agreement. We look forward to hearing from all of you and
    moving ahead in this area.
        With that, Mr. Chairman, if there are others seeking time,
    I would be happy to yield the balance. Otherwise, I will yield
    back and we can get on with the hearing.
        [The prepared statement of Mr. Walden follows:]

                     Prepared statement of Hon. Greg Walden

        Thank you, Chairman Burgess.
        What a difference 5 years makes. The last time Congress
    reauthorized the Medical Device User Fee Amendments (MDUFA) in
    2012, we heard story after story about venture capital drying
    up and innovative medical technology companies launching their
    products overseas, oftentimes years before American patients
    could benefit from them. Time after time, witnesses from all
    sides of the political spectrum came before this subcommittee
    and highlighted the burdensome, inconsistent, and opaque nature
    of the FDA review process as the primary driver of these
    alarming trends.
        Thanks to Dr. Burgess and others, the Food and Drug
    Administration Safety and Innovation Act (FDASIA) included a
    number of common-sense regulatory improvements that greatly
    benefitted patients and spurred innovation. I also want to
    thank Dr. Jeff Shuren for his leadership. All of the
    legislation in the world could not change the deeply rooted
    cultural issues that were plaguing the device center at FDA. He
    took these criticisms to heart and then put these new
    legislative authorities to work.
        Since 2009, the number of innovative devices approved by
    the FDA has almost quadrupled and American patients are
    benefiting from safe and effective American technologies
    sooner. In 2009, it took an average of 427 days before FDA even
    reached a decision on a premarket approval application (PMA).
    As of 2015, the average review time was down to 276 days--a 35
    percent decrease.
        Building upon the successful implementation of the previous
    user fee agreement, 21st Century Cures included a number of
    additional bipartisan process reforms. Reauthorizing MDUFA in a
    timely fashion-which I remain steadfastly committed to doing-
    will ensure that we continue to move in the right direction.
    This is a good agreement that will further strengthen the
    agency, improve the lives of patients, and bolster America's
    medical technology sector which has brought hundreds of
    thousands of high-paying jobs to our communities.

        Mr. Walden. With that, Mr. Chairman, if there are others
    seeking time, I would be happy to yield the balance. Otherwise,
    I will yield back and we can get on with the hearing.
        Mr. Burgess. The Chair thanks the gentleman. The gentleman
    yields back.
        The Chair, then, recognizes the ranking member of the full
    committee, Mr. Pallone of New Jersey, 5 minutes for your
    opening statement, please.

    OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
                IN CONGRESS FROM THE STATE OF NEW JERSEY

        Mr. Pallone. Thank you, Mr. Chairman.
        I appreciate the opportunity today to discuss the
    reauthorization of the Medical Device User Fee Amendments. I am
    pleased to see the progress that has been made under MDUFA in
    reducing review times for medical devices as well as ensuring
    that the Center for Devices and Radiological Health is well-
    resourced and well-staffed.
        I would also be remiss if I didn't acknowledge the positive
    response from industry in terms of how MDUFA III is working, a
    dramatic shift from where things stood prior to reauthorization
    in 2012.
        A lot has been accomplished in meeting the goal of reduced
    review times under the MDUFA program. Average total review
    times for 510(k)s are down by 11 percent and average total
    review times for pre-market applications are down by 35
    percent, or 150 days.
        Importantly, CDRH also approved the highest number of novel
    devices in the history of the MDUFA program in 2016, approving
    91 new devices. While more work needs to be done, this progress
    has resulted in patient access to safe and effective medical
    devices more quickly, which is a goal I think we all share.
        And MDUFA IV will build on these successes by working to
    improve the Medical Device User Free Program. It will advance
    the use of the patient perspective and the risk/benefit
    assessment of medical devices. It will also establish a system
    called the NEST to utilize real-world data for pre-market
    approval of new indications and post-market safety monitoring.
    It tailors the use of the third-party review program and
    improves pre-submission communications with sponsors. All of
    these actions will help to improve the consistency, efficiency,
    and effectiveness of medical device reviews.
        Just as I have said before on the other User Fee
    Agreements, the agreement before us today is the result of many
    negotiations with industry and stakeholders, consultations with
    patients and consumers, and solicitation of public input. The
    resulting recommendations were transmitted to Congress in
    meeting the January 15th statutory deadline.
        Transmitting new recommendations at this point would go
    against this requirement and run the very real risk of MDUFA
    not being reauthorized before the program expires on September
    30th. Any delays would endanger the review of innovation
    medical devices and threaten the jobs of thousands of FDA
    employees.
        So, I intend to continue to work with my colleagues on the
    committee and across the Capitol as well as industry to ensure
    that we do not let this happen. This is a strong agreement and
    one that deserves our support, and I look forward to continuing
    our work on all of the User Fee Agreements to ensure that they
    are signed into law as soon as possible.
        [The prepared statement of Mr. Pallone follows:]

                 Prepared statement of Hon. Frank Pallone, Jr.

        Thank you, Mr. Chairman. I appreciate the opportunity today
    to discuss the reauthorization of the Medical Device User Fee
    Amendments.
        I am pleased to see the progress that has been made under
    MDUFA in reducing review times for medical devices, as well as
    ensuring that the Center for Devices and Radiological Health
    (CDRH) is well-resourced and well-staffed. I would also be
    remiss if I did not acknowledge the positive response from
    industry in terms of how MDUFA III is working, a dramatic shift
    from where things stood prior to reauthorization in 2012.
        A lot has been accomplished in meeting the goal of reduced
    review times under the MDUFA program. Average total review
    times for 510(k)s are down by 11 percent, and average total
    review times for pre-market applications are down by 35 percent
    or 150 days. Importantly, CDRH also approved the highest number
    of novel devices in the history of the MDUFA program in 2016,
    approving 91 new devices. While more work needs to be done,
    this progress has resulted in patient access to safe and
    effective medical devices more quickly, which is a goal I think
    we all share.
        MDUFA IV will build on these successes by working to
    improve the medical device user fee program. It will advance
    the use of the patient perspective in the risk-benefit
    assessment of medical devices. It also establishes a system
    called the NEST to utilize real world data for premarket
    approval of new indications and post-market safety monitoring.
    It tailors the use of the Third Party Review program, and
    improves pre-submission communication with sponsors. All of
    these actions will help to improve the consistency, efficiency,
    and effectiveness of medical device reviews.
        Just as I have said before on the other user fee
    agreements, the agreement before us today is the result of many
    negotiations with industry and stakeholders, consultations with
    patients and consumers, and solicitation of public input. The
    resulting recommendations were transmitted to Congress in
    meeting the January 15, 2017 statutory deadline. Transmitting
    new recommendations at this point would go against this
    requirement, and run the very real risk of MDUFA not being
    reauthorized before the program expires on September 30. Any
    delays would endanger the review of innovative medical devices
    and threaten the jobs of thousands of FDA employees.
        I intend to continue to work with my colleagues on the
    committee and across the Capitol, as well as industry, to
    ensure that we do not let this happen. This is a strong
    agreement, and one that deserves our support, and I look
    forward to continuing our work on all of the user fee
    agreements to ensure they are signed into law as soon as
    possible.
        Thank you.

        Mr. Pallone. I have 2 minutes left. I don't think anybody
    wants the time. But, with that, I will yield back, Mr.
    Chairman.
        Mr. Burgess. The gentleman yields back. The Chair thanks
    the gentleman.
        And that concludes Member opening statements. The Chair
    would like to remind Members that, pursuant to committee rules,
    all Members' opening statements will be made part of the
    record.
        Again, we want to thank our witnesses for being here today,
    for taking time to testify before the subcommittee. Each
    witness will have the opportunity to give an opening statement,
    followed by questions from Members.
        We will have two panels of witnesses today, and we are
    going to begin with Dr. Jeffrey Shuren, the Director for the
    Center for Devices and Radiological Health at the Food and Drug
    Administration, no stranger to this subcommittee.
        Welcome back, Dr. Shuren. We look forward to your
    testimony. You are recognized for 5 minutes, please.

    STATEMENT OF JEFFREY SHUREN, M.D., DIRECTOR, CENTER FOR DEVICES
        AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION,
                DEPARTMENT OF HEALTH AND HUMAN SERVICES

        Dr. Shuren. Chairmen Walden and Burgess, Ranking Members
    Pallone and Green, and members of the subcommittee, thank you
    for the opportunity to discuss the reauthorization of the
    Medical Device User Fee Amendments, or MDUFA, today.
        When I was last here testifying about MDUFA, I am sure many
    of you recall, and have already mentioned, that the program was
    in a much different place. Since then, much has changed for the
    better, but we have more work to do.
        As you have heard, between 2010 and 2016, we reduced the
    average total time to reach a decision on the 510(k), the
    submission type for lower-risk medical devices, by 11 percent.
    Between 2009 and last year, we reduced the average total time
    to reach a decision on a PMA, the submission type for a high-
    risk device, by 35 percent, reducing by 150 days.
        But we went beyond our MDUFA III commitments. For example,
    we reduced the median time to approve a clinical trial
    submission from 442 days in 2011 to just 30 days in 2015 and
    2016, a 93-percent decrease. Changes we have made at the Center
    for Devices and Radiological Health, or CDRH, to our culture,
    our policies, and our processes, the investments provided by
    industry through user fee funding, and the direction provided
    by Congress through changes to Federal law, have resulted in
    improved medical device pipeline and innovative technologies
    being introduced in the U.S. earlier than in the past. In fact,
    the number of novel devices we have approved has almost
    quadrupled from 24 in 2009, when I first came to CDRH, to 91 in
    2016, the highest since the start of the User Fee Program in
    2003.
        Last year we approved the first artificial pancreas,
    working interactively with the device manufacturer from the
    early stages of development. We approved the first device in
    the world that is intended to automatically monitor glucose
    levels around the clock and automatically provide insulin
    doses. Overall, working with the manufacturer, we helped bring
    this technology to market 3 years earlier than the company
    originally intended to do.
        MDUFA IV could continue that trajectory for more timely
    patient access to novel technologies, supporting CDRH's vision
    that patients in the U.S. have access to high-quality, safe,
    and effective medical devices of public health importance first
    in the world.
        The MDUFA IV proposal submitted to Congress in January
    includes programmatic enhancements, such as a new quality
    management program that will improve consistency, efficiency,
    predictability, and the application of the least-burdensome
    approach in our pre-market review processes and decisionmaking.
    The proposal would allow FDA to move forward in some critical
    and strategic areas, such as strengthening our partnerships
    with patients, allowing us to promote more patient-centric
    clinical trials, advanced benefit/risk assessments that are
    informed by patient perspectives, and foster earlier patient
    access to new devices.
        Another critical area is the development of the National
    Evaluation System for health--with a small ``h''--Technology,
    or NEST. The NEST is a nongovernment system that will be
    operated by stakeholders of the medical device ecosystem,
    including patients, providers, and the device industry, and it
    would facilitate the use of real-world data, collected as a
    part of routine clinical care, such as from electronic health
    records and registers, consistent with the goals of 21st
    Century Cures.
        A robust NEST will enable manufacturers to harness real-
    world evidence that could enable them to drive down the time
    and cost of bringing new devices to market, expanding the
    indications to already marketed drugs, meeting post-market
    reporting requirements, and obtaining payer coverage and
    reimbursement. The NEST will also enable faster identification
    of safety issues, reducing harm to patients and liability for
    companies.
        In conclusion, the authorization of the Medical Device User
    Fee Program would expedite the availability of innovative new
    products, create jobs, protect patients, and provide the
    enhancements that will continue to increase the efficiency of
    FDA's programs. Improvements in total time to decision,
    transparency, consistency, predictability, efficiency, and
    assuring a least-burdensome approach will benefit industry,
    healthcare providers, and, most importantly, patients.
        Thank you for the opportunity to testify here today. I look
    forward to answering your questions.
        [The prepared statement of Dr. Shuren follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Burgess. The Chair thanks Dr. Shuren for his testimony,
    and we will move into the question portion of the hearing. I
    will begin with the questioning and recognizing myself for 5
    minutes.
        I do want to stress to Members that we do have a lot of
    members on the subcommittee who are anxious to interact with
    Dr. Shuren. So, let us try to keep our question time to 5
    minutes. If necessary to do followups afterwards, perhaps we
    can arrange to do that.
        But, Dr. Shuren, I remember several of these rounds before,
    and I just have to say how optimistic your statement is and how
    optimistic the approach that your Center is taking to this
    process. For that, I thank you. There is a difference.
        You talked in your opening remarks about a least-burdensome
    approach, and certainly that is something that we heard from a
    number of people at some of these hearings in 2012, that they
    were anxious to see that.
        So, I just ask you, what has changed at your Center
    culturally to allow for things to be so different today than
    they were 5 years ago?
        Dr. Shuren. I think one of the biggest differences in
    culture is we are putting the emphasis on the other side of our
    mission. For so long, we focused on protecting public health.
    We also have to think about promote public health. It is not
    just assuring that medical devices are safe and effective, but
    also that patients have timely access. And we facilitate device
    innovation. That is what you see in our vision statement, and
    that is why it is so important. That first in the world is
    really not about beating other countries. It is about getting
    timely patient access. That is simply a good metric.
        We have moved towards more of a flexible benefit/risk
    paradigm in how we think about technologies. It helps bring
    them to market more quickly, but appropriately.
        We are factoring in the perspectives of patients. What are
    the values, the tradeoffs, they are willing to make in
    decisions? And now, we are relying more and more on real-world
    evidence, which can be generated in a number of cases in less
    time and lower cost.
        Mr. Burgess. Well, you mentioned in your opening remarks
    about the artificial pancreas. And I can remember discussions
    with patient groups and parents and folks who were interested
    in that, the difficulty with getting DS on that. So, I
    certainly acknowledge what a milestone that was.
        I just can't tell you the relief and gratitude that I have
    heard, particularly in parents' voices when they say that, you
    know, ``My iPhone alerts when my child's glucose is getting
    outside of the prescribed range...'' and to be able to deliver
    some measure of control back to the patient, back to their
    caregivers, that is an enormous gift.
        Five years ago, I was critical because it was taking too
    long. I am glad that you moved it along. I am glad that it was
    accelerated. I think it underscores what you were saying, that
    we are not just about protecting patients; we have got to
    deliver for patients. And I think the artificial pancreas is
    probably the No. 1 case that makes that point. I welcome the
    cultural changes, and whatever was required on your part to
    achieve those, I think we are grateful for that.
        Now in 21st Century Cures you participated in some of the
    roundtables. I know we had a number in this very room. It was
    configured a little differently, for those who are watching on
    television, but it was here in the main committee room.
        We heard about patient participation in drug and device
    development and the product review process. Can you talk about
    how the Review Division staff in the Device Center will now be
    incorporating patient perspectives into their decisionmaking?
        Dr. Shuren. We have started that process already. One of
    the areas we started to focus on is, how do you better
    understand the perspectives of patients? I mean, you can ask
    people, but, you know, within that patient population they
    substratify. So, we have been advancing the science of patient
    preferences. What are the tools you can use to more
    quantitatively assess the tradeoffs patients are willing to
    make?
        We did this in a study on obesity devices. In 2007 to 2014,
    we hadn't----
        Mr. Burgess. Sir, what type of devices?
        Dr. Shuren. For obesity. And we hadn't approved anything
    from 2007-2014. When we incorporated patient perspectives, we
    changed our paradigm, we approved a device then. We have
    approved five more since then. The pipeline is rich.
        So now, what we are doing is we have put out policy on
    factors to consider in doing these studies. Companies are now
    coming to us. We are training our staff. And with MDUFA IV, we
    will have the resources to build a patient engagement program,
    giving us the expertise to provide advice on the design and use
    of patient preference information, patient-reported outcomes,
    and better designing clinical trials around patients' needs and
    their preferences.
        Mr. Burgess. I am glad you mentioned that because, of
    course, many of the device manufacturers are very small and
    perhaps lack the resources of their larger counterparts. I am
    going to submit that question for the record, but I am
    interested in the answer to that question.
        In the interest of time, I am going to recognize the
    gentleman from Texas. Five minutes for questions, please.
        Mr. Green. Thank you, Mr. Chairman.
        Again, Dr. Shuren, I want to thank you and your staff for
    the progress, because bringing in the patients, the patient
    advocates, it just expands it, and it is much better if
    everybody is at the table, particularly patient advocates who
    come in with resources and experience that helps you.
        I understand the National Evaluation System for health
    Technology, or NEST, has the potential to make it less
    expensive to bring new device to market, expand or approve
    users for existing products, and post-market requirements for
    harnessing real-world data collected during the routine care.
    Can you explain what the NEST is and how it is incorporated
    into the agreement? Specifically, how does NEST differ from the
    CDRH currently and how it will generate value to patients, the
    FDA, and the medical device industry?
        Dr. Shuren. One of the great inefficiencies we have in our
    healthcare system is that we gather information every single
    day in patient encounters, but we can't make great use of it
    because it may not be standardized; it may be incomplete; it
    may be of poor quality. And it sits in electronic health
    records, registries, payer claims.
        What NEST is about is, how do you use market-based
    principles? How do you use the collective purchase power of the
    ecosystem to drive towards greater standardization and
    consistency, drive down the time and cost of being able to
    leverage that information and, then, to use it to inform
    decisionmaking, generate the evidence for products to come to
    market, as well as to meet post-market requirements?
        So, for example, in this past year we approved a device, a
    balloon stent. It was based solely on real-world evidence that
    came from device registries.
        We have expanded labeling indications based on device
    registries. Companies today are leveraging device registries
    for their post-market study requirements. They are finding a
    40-to-60-percent decrease in the cost of those studies. So, it
    is already having an impact.
        What NEST does is it makes it more systematic. Cost goes
    down further, and it can be readily available for more device
    types and more device companies.
        Mr. Green. Thank you.
        The 2015 decision time decreased 35 percent. While this is
    great in understanding the most recent MDUFA Quarterly Report,
    the FDA's time for metrics to review PMA devices went up. Do
    you know what is behind this increase and what sort of tools
    are included in the new MDUFA agreement that would help prevent
    these sorts of total time increases in the future?
        Dr. Shuren. We are starting to see a little bit of an
    upturn, which is why it is so important that you are monitoring
    the data constantly. We are in the midst of doing a deeper dive
    and we are looking at a variety of factors. One is the
    increased workload that we saw under MDUFA III, and
    particularly for the most innovative devices, like PMAs and de
    novos.
        So, in fact, one of the contributors might be the success
    of the program is leading to the more innovative, more complex
    technologies coming to the U.S., which is a good time. But we
    are looking into it and we will take the appropriate action.
        What MDUFA IV will provide is certainly more resources to
    be able to do the work, but I also think do the work more
    efficiently by building in a quality management system to help
    us drive towards improving our processes, reduce waste, lower
    cost, and improve the effectiveness of our programs.
        Mr. Green. And, of course, while we are working on MDUFA,
    if you have any suggestions for it? I know there has been a
    partnership over the last number of months, and years even, to
    working. But, if we can help that, what we need to do with this
    legislation, just please let us know. And that is really a
    bipartisan issue.
        I know digital health is a key area and focus for FDA. I
    want to thank the agency for its work with us in the last
    Congress. Advances in technology have potential to transform
    medical care, ensuring FDA has the right tools in place to
    ensure patient safety, and appropriate oversight of the
    category of devices as a goal. Software as a medical device and
    software inside medical devices are two specific addressed in
    MDUFA IV. Can you talk about the commitment has to build
    expertise and enhance the review process for such software?
        Dr. Shuren. Well, one of the key components of MDUFA IV
    reauthorization would be to establish digital health units
    centrally within the Center to help drive rate of coordination
    and consistency. The way we will set this up is that our review
    staff who deal with software as in medical devices, they will
    get basic training. They will sort of be yellow belts. They
    will deal with more general issues.
        Then, within the offices, we will have better trained
    people, kind of the green belts. You can think about this
    Digital Health Unit. These are the black belts who get involved
    in the more challenging submissions who can oversee training,
    assure consistency.
        But the other part of this agreement is to continue our
    international harmonization work and the International Medical
    Device Regulators Forum, IMDRF, which is critical, driving more
    international harmonization, but also revisiting the paradigm.
    So, we are looking to change the paradigm on software as a
    medical device to better meet the rapid innovation cycles we
    see in these technologies. We are working collaboratively with
    others on trying to establish that new paradigm.
        Mr. Green. Thank you, Mr. Chairman.
        Mr. Burgess. The gentleman yields back. The Chair thanks
    the gentleman.
        The Chair recognizes the gentleman from Michigan, Mr.
    Upton, chairman emeritus of the committee. Five minutes for
    questions, please.
        Mr. Upton. Thank you, Mr. Chairman.
        And, Dr. Shuren, thank you. Jeff, thank you very much for
    all your participation. You were really terrific as we moved
    21st Century Cures to the goal line. Your participation in this
    room and as part of a number of roundtables, your participation
    around the country in roundtables was very important, and we
    really appreciated all your work on that.
        You give us some really good news in terms of the progress
    that you have made over the last 5 or 6 years. It reminds me of
    when I was going through a major facility in our district,
    Stryker, years ago, before this process really started. I can
    remember going with the then-chairman of Stryker looking at a
    6-, 7-hundred-thousand-new-square-foot manufacturing facility
    in Michigan. And I said to him, I said, ``Jeff,'' I said,
    ``what do you think?'' And he said, ``I just wondered if we
    should have built this in China.''
        And that was because we were lagging behind. We didn't have
    these approval rates like we have now. You could talk about the
    artificial pancreas approval 3 years ahead of what the experts
    thought would happen; it is really great news. Because not only
    are we seeing those benefit the patients that need them, but I
    have got to believe that that is going to be built here in the
    U.S. That is going to be the jobs that we all want, the high-
    tech jobs that are going to be there that we all want.
        So, I guess your colleague Dr. Woodcock was here about a
    week ago. She talked about, if we don't get this done, heaven
    forbid, but if we don't get it done and send the signal
    probably by the end of June or July, the end of July, that they
    would expect that they would perhaps a 70-percent reduction,
    and they would have to start sending out RIF notices to folks.
    We are going to do everything we can to make sure that that
    doesn't happen, that we are going to work together to get it
    done.
        But what would be the impact and what is the timing as it
    relates to PDUFA for your large chapter of where we want to
    head as well? What is the latest that you need to hear from us?
        Dr. Shuren. Well, first, let me take the moment to thank
    you and Congresswoman DeGette, and all the members on the
    subcommittee and on the committee, for your leadership in the
    21st Century----
        Mr. Upton. We didn't lose a one, I want you to know. It was
    unanimous in this committee, thanks to the leadership on both
    sides.
        Dr. Shuren. So, the impact and the timing for us, if MDUFA
    were to sunset, not get reauthorized in time, we would lose
    about a third of our staff. As Dr. Woodcock said, it is about
    60 days before that law sunsets that we need to start the
    process on a reduction-in-force, RIF.
        So, it has huge implications, and it is not just even the
    people you lose, but for the people who remain. Your best and
    your brightest leave because they see it is a sinking ship and
    they are going to get off and move on to other things.
        So, it is our hope that we would have the law reauthorized
    before we need to start that process for a RIF.
        Mr. Upton. So, my next question is, great news about the
    artificial pancreas, and we have been watching that a while and
    what it would do, and particularly to the diabetic community
    across the country.
        What are some of the devices that you have in the pipeline
    that you think may be--you know, assuming that things go well,
    tell us a little bit about that next chapter. What are some of
    the things that you see on the horizon for us getting done?
        Dr. Shuren. Well, you know, I think where technology is
    going, you are going to see more and more use of robotics. You
    are going to see technology get smaller and smaller, you know,
    micro-sized. You are going to see less-invasive surgeries
    happening.
        Another great example is on the transcatheter aortic heart
    valve. When we first approved it here, it was 4 1A\1/2\ years
    after it came CE-marked in Europe. This past year we just
    approved expanding use in another population. It was 18 days
    after Europe for similar technology.
        But we are going to see other things like using maybe
    ultrasound, instead of a scalpel, ultrasound that drives down
    to start to do surgery under the skin. So, there are amazing
    things that have happened. And I think the U.S. can truly be
    the world's leader if we continue on the trajectory we have
    been on.
        Mr. Upton. Thank you. Thanks again for your work, and we
    look forward to working with you in the days ahead.
        I yield back my time.
        Mr. Burgess. The Chair thanks the gentleman. The gentleman
    yields back.
        The Chair, then, recognizes the gentlelady from California,
    Ms. Eshoo. Five minutes for questions, please.
        Ms. Eshoo. Thank you, Mr. Chairman.
        And welcome back, Dr. Shuren. It is good to see you.
        I want to commend you and your entire team for the report
    that you have brought forward. It contains a great deal of good
    news, and that good news affects patients, No. 1, I think. It
    is a compliment to you and the industry for the work that you
    have done together.
        This is a very important American industry. We want to keep
    it that way and keep it vibrant. I can't help but, as the
    mother of MDUFA--it was my legislation that created this
    process--it is deeply gratifying to see how it has really come
    along, and that we are where we are today. So, bravo to you.
        I also want to thank you for meeting on a quarterly basis
    with Congressman Erik Paulsen and myself, as co-chairs of the
    Medical Technology Caucus. We have done this for some time. We
    bring up the issues just the way they are presented to us by
    constituents, by patients, and I hope that you think that those
    meetings have been as rewarding as we do. And we are very
    grateful to you for that.
        How much money is in the user fees for this go-around, for
    this reauthorization?
        Dr. Shuren. So, for this reauthorization, without adjusting
    for inflation, the total over the 5 years would be about $999.5
    million.
        Ms. Eshoo. And it is adjusted for inflation as opposed to
    what you are operating under now? Or did the industry come up
    with more?
        Dr. Shuren. MDUFA III also was adjusted for inflation, too,
    for over time.
        Ms. Eshoo. And how many staffers do the user fees pay for?
        Dr. Shuren. So, currently, if you just said----
        Ms. Eshoo. I think you said, what, a third of the----
        Dr. Shuren. Yes, so it is about a third of----
        Ms. Eshoo [continuing]. A third of your Division?
        Dr. Shuren. If you were paying for full salary, in reality,
    the number of people who work in the User Fee Program in one
    way, shape, or form is probably a little over 90 percent of the
    program.
        Ms. Eshoo. Well, I think every member of this subcommittee,
    and hopefully the full committee, will have a deep appreciation
    of that.
        No. 1, I think the negotiations that you have completed
    should be accepted by the Congress. I mean, it has been worked
    out. I don't think there is anything to meddle with, unless
    Members have something that they think needs to be brought up.
    But I think that this is ready for primetime.
        So, I don't have anything that I want to add to it. What I
    would like to know is, I know that the FDA participates in the
    International Medical Device Regulators Forum. I know it is a
    voluntary body of device regulators around the world to talk
    about future directions in the medical technology world and in
    regulatory harmonization, which I think is very, very important
    because these products end up being global.
        What can you tell us about that? What is news with it?
    Where do you see things moving? What are some of the activities
    that the FDA is working on in this area? And then, of course,
    the operational question around here always is, what else do
    you think needs to be done?
        Dr. Shuren. So, the latest is in the past year we
    officially stood up medical device single audit programs, so a
    surveillance inspection conducted by one participating
    jurisdiction is relied on in whole or in part by another
    jurisdiction. So, that reduces a lot of cost to companies. You
    have fewer inspectors coming in the door. It is good for
    Government because we have a broader view of the facilities out
    there.
        Our work is advancing on harmonizing international
    regulation on software as a medical device. We are doing work
    to advance the use of standards, international and national
    standards, very important for also driving down time and cost
    and greater consistency.
        And the next place where we are just starting in, and I
    think will be the biggest project we have taken on, is pulling
    the building blocks together to, hopefully, establish a Medical
    Device Single Review Program, where the approval decisions by
    one participating jurisdiction, again, are relied on in whole
    or in part by another jurisdiction. That would probably be one
    of the most fundamental changes in the medical device arena.
    And if there is anything that is going to push a least-
    burdensome approach, it is that effort. And the U.S. is the one
    who proposed it and we are the ones who are leading it.
        Ms. Eshoo. Bravo. Thank you very, very much, and to your
    entire team. Great to see you.
        Thank you, Mr. Chairman.
        Mr. Burgess. The gentlelady's time has expired. The
    gentlelady yields back.
        The Chair recognizes the gentleman from Pennsylvania, Mr.
    Murphy. Five minutes for questions, please.
        Mr. Murphy. Thank you, Mr. Chairman, and thank you, Dr.
    Shuren, for being here.
        A recent survey found that the majority of Americans
    believe that proper servicing and maintenance of medical and
    radiation-emitting electronic devices is crucial to protecting
    patients, and that all medical services should be consistently
    regulated by the FDA, regardless of whether they are an
    original equipment manufacturer or a third party.
        Can you give us some update on where things stand on rules
    for third-party service of medical devices in order to ensure
    this safety?
        Dr. Shuren. Yes. Well, we agree both that we need safe
    servicing, but also the importance of having good servicing
    available. We held a workshop back in October of last year, and
    we heard a great input from the original equipment
    manufacturers as well as from the third-party servicing
    industry, from patients, and from others. Right now, we are
    still going through the feedback we received, and we still have
    groups who are coming in and talking to us. So, we are still in
    the data-gathering mode at this point.
        Mr. Murphy. Do you anticipate any dates by which you are
    going to have some resolution of this?
        Dr. Shuren. I don't at this point, and this is also an
    issue that we will be discussing and working with our
    colleagues at HHS on.
        Mr. Murphy. But you agree with the general concept that you
    have to make sure that services are more or less approved in
    going through with this?
        Dr. Shuren. We do want to make sure that they are of high
    quality, and we heard issues on both sides, both from the
    original equipment manufacturers, the importance of having
    people who are well-trained, using appropriate parts. We also
    heard from the servicers, making sure that they have access to
    the right training. Couldn't they get the parts that they
    needed?
        So, finding sort of what is the best path forward to
    address concerns and make sure we have a safe, but rich
    environment out there will be important.
        Mr. Murphy. Thank you. I look forward to getting updates
    from you on that.
        Next, I just want to talk this global economy here. I am
    interested in ways we can harmonize regulatory processes around
    countries, so the companies can realize efficiencies and
    patients can have access to lifesaving devices in a more timely
    manner, part of what was approached in 21st Century Cures.
        But I want to know about harmonization efforts here that
    you are working on or that you would ask Congress to consider.
    Could you comment on some of those?
        Dr. Shuren. Well, I think the big one that allows that sort
    of fast-to-our-patient access is this Medical Device Single
    Review Program. We just put in place policy under this
    International Medical Device Regulators Forum, IMDRF, for
    competency, training, and conduct of third-party reviews. So,
    that is the very first building block.
        We just adopted a new work item to revisit sort of a
    foundational document that we call the Central Principles on
    Health and Safety, and safety and performance, that we will be
    working on next.
        So, it is going to take a little bit of time. There are
    other issues, too, related to harmonization that we will need
    to tackle as a country. And it is things that we are in
    discussion with HHS about, and I hope we have an opportunity to
    maybe discuss again when there is more information to provide.
        The last piece is MDUFA IV also provides greater support
    for a more robust third-party review program, which is going to
    be important if we are ever to get to the place of that
    harmonized single review program. It is not just about more
    efficiencies domestically, but it can give us a leg up for
    moving to truly a global medical device review program.
        Mr. Murphy. Thank you.
        Next, I want to talk about security, more particularly,
    more specifically, cybersecurity as it relates to the privacy
    of the records of devices, of manufacturing, et cetera. But it
    frequently comes up in the context of these medical
    technologies. How has FDA been engaging in this issue about
    cybersecurity with devices?
        Dr. Shuren. So, to date, we have put out several policies
    on cybersecurity, both on the pre-market and post-market. We
    have been adopting national and international standards. We
    have been working with other agencies, particularly with the
    Department of Homeland Security through their ICS-CERT, with
    the Department of Commerce, with FTC, and with the HHS
    Cybersecurity Working Group.
        One of our more recent efforts is an MOU with the NH-ISAC,
    the National Health Information Sharing and Analysis Center, to
    establish what we call an information-sharing and analysis
    organization. It is essentially a community that allows sharing
    amongst members in the device ecosystem about vulnerabilities
    and about safeguards to take.
        This is a critical part about cybersecurity. It is a shared
    responsibility. It doesn't fall to one entity. And we need the
    members of the ecosystem sharing information, working what we
    call researchers, the white hat hackers, so we can identify
    what are the vulnerabilities and put in safeguards, recognizing
    that because the people who hack, they get smarter and smarter,
    and the risks continue to evolve. You have to constantly keep
    up on this. So, you need that kind of active forum.
        Mr. Murphy. Thank you, Mr. Chairman. I will submit the rest
    of my questions for the record. I yield back.
        Mr. Burgess. The gentleman yields back. The Chair thanks
    the gentleman.
        The Chair now recognizes the gentlelady from Colorado, Ms.
    DeGette. Five minutes for questions, please.
        Ms. DeGette. Thank you, Mr. Chairman.
        First of all, I would like to add my thanks, Dr. Shuren,
    for the approval of the artificial pancreas, on behalf of the
    Diabetes Caucus, but also on behalf of my family because, as
    you know, my daughter is a type 1 diabetic and will be one of
    the first users of this. So, thank you very much.
        I want to talk to you a little bit about some of what
    President Trump's Executive Orders are doing to the agency and
    what this will mean for the implementation of 21st Century
    Cures. Because we are all having what we feel is a much-
    recognized bipartisan lovefest around our great committee
    achievement last year, and we are really proud of it and what
    it has done in the medical device arena. But we are concerned
    about, at least I am concerned about some of the announcements
    emanating from the administration. I would like to get some
    clarification from you, if you have some.
        Some of us sent a letter to the administration a couple of
    weeks ago about the hiring freeze. And we are concerned in the
    medical device arena that the hiring freeze will stop us from
    hiring the right people that we need to implement the bill. And
    we are awaiting a response for that.
        But there is another issue that also I think threatens
    Cures and the user fee implementation. That is President
    Trump's repeated calls to deregulate the FDA. A couple of weeks
    ago, he said he wants to cut up to 75 to 80 percent of all FDA
    regulations.
        And the problem I have, you know, nobody likes unnecessary
    or overly burdensome regulations. Nobody ever, ever wants that
    to happen. But what the President seems to do is he sort of
    seems to do this with a meat axe. So, for example, he had
    issued this Executive Order saying that, if you are going to
    have a new regulation, then you are going to drop two
    regulations without looking at what the arena is that you are
    talking about or what the regulations are.
        And I think this is of particular concern with the FDA when
    it comes to agency guidance because, when you guys issue agency
    guidance, then that helps the stakeholders understand how the
    FDA is implementing and interpreting the rules and laws. Even
    when the stakeholders don't agree, at least they know where you
    are coming from.
        And so, I am concerned, if you have this repeal two for
    every one you adopt, then that is going to also--not only is it
    going to hurt with the agency guidance, but it is going to help
    with many of the provisions for 21st Century Cures. The
    breakthrough device pathway is a really good example. And the
    CLIA waiver provisions in Cures, they call for new guidance.
    So, how are we going to drop two if we are enacting one? It is
    also going to complicate issuance of guidance documents under
    MDUFA IV, such as third-party review.
        So, my question to you, has the Trump administration
    clarified to the extent to which an Executive Order applies to
    a guidance issued by an agency?
        Dr. Shuren. Well, first of all, I will say we recognize the
    importance of issuing appropriate guidances and regulations.
        Ms. DeGette. Right.
        Dr. Shuren. Right now, we are working with our colleagues
    at HHS on implementation of the Executive Order. But I can tell
    you we are already moving forward to implement 21st Century
    Cures.
        Just a few weeks ago, we put out a notice of medical
    devices that are Class II that we are proposing should no
    longer have to submit at 510(k).
        Ms. DeGette. That is great.
        Dr. Shuren. And that, you know, we will look at public
    comment, but that would deregulate, if you will, over 1,000
    medical devices. So, we are already moving forward on those.
        Ms. DeGette. So, you are trying to work with HHS on
    interpreting what that Executive Order means at this point with
    respect to guidances?
        Dr. Shuren. Yes.
        Ms. DeGette. OK. Now, if you are not able to issue new
    guidances, will the Cures implementation be impacted by that?
        Dr. Shuren. Yes.
        Ms. DeGette. Breakthrough devices is the perfect example.
        Dr. Shuren. That is correct, because we are called on in
    the statute to also issue certain guidances. But, again, as of
    right now, we have been able to put in place the things we need
    to do to meet statutory deadlines and----
        Ms. DeGette. That is good. Will you please let us know if
    you start seeing impediments to implementing 21st Century Cures
    because of this? And I know we can work on both sides of the
    aisle to make sure that the implementation goes smoothly.
        Thank you.
        Thank you very much, Mr. Chairman. I yield back.
        Mr. Burgess. The gentlelady yields back. The Chair thanks
    the gentlelady.
        The Chair recognizes the gentleman from Indiana, Dr.
    Bucshon. Five minutes for questions, please.
        Mr. Bucshon. Thank you, Dr. Shuren, for being here.
        I am interested in bringing more predictability and
    consistency to the device inspections process. It is a little
    bit off the beaten path. But, for routine inspections, the FDA
    should be able to give companies a reasonable heads-up about
    what they are inspecting as well as provide regular
    communications throughout the inspection. I think you probably
    agree with that.
        Additionally, should the FDA find an issue that needs to be
    addressed during an inspection, companies have 15 days to
    submit a remediation plan to FDA, but there is no such timeline
    for the FDA to respond to companies, to communicate whether the
    remediation plan meets FDA expectations.
        Can you comment on what CDRH might be able to do to address
    these issues?
        Dr. Shuren. Well, although we are not the lead on this--our
    Office of Regulatory Affairs oversees the fields--we do work
    very closely with our colleagues over in ORA. And I can tell
    you, as a part of the program alignment effort, which is
    getting officially stood up in the coming weeks, as part of
    that, I know ORA--and we will be working with them--is looking
    to revisit their standard operating procedures and other
    processes to make device inspections more efficient, more
    timely, and to have the right kind of engagement back with the
    companies.
        Mr. Bucshon. Great, and I think that is important that you
    do engage in that process really to try to improve everything
    across the spectrum as it relates to the device industry.
        My colleague Ms. Brooks and Mr. Butterfield and Mr. Peters
    introduced legislation yesterday to try to address some of
    these issues. And so, I look forward to working with everyone
    on trying to improve that situation.
        Mr. Chairman, I yield back.
        Mr. Burgess. The gentleman yields back. The Chair thanks
    the gentleman.
        The Chair recognizes the gentlelady from Florida, Ms.
    Castor. Five minutes for questions, please.
        Ms. Castor. Well, thank you, Mr. Chairman, for calling this
    hearing today.
        And welcome, Dr. Shuren.
        Patients understand better than anyone about the impact
    treatment will have on their daily lives, and they have a
    unique perspective to add, as the benefits and risks of
    different treatments are considered. There has been
    considerable interest from the patient community and families
    in incorporating the patient perspective into both the drug and
    device regulatory review process and the development process.
        Dr. Shuren, please discuss how the proposed MDUFA IV
    agreement works to further incorporate the patient perspective
    into the medical device regulatory process. And if you would,
    give us a few examples.
        Dr. Shuren. Well, it will build on work that we have done
    to date and establish sort of a patient engagement program
    within CDRH; allow us to have the expertise we need to provide
    greater advice and abilities in reviewing studies that are
    conducted to assess patient preferences, to advance the
    incorporation and the voluntary use of patient-reported
    outcomes, so we are measuring the things that matter the most
    to patients; how we more systematically incorporate the
    perspectives of patients in the design of clinical trials. We
    have to design studies not around the needs of the
    investigators, but the lifestyles of the patients who
    participate in those studies.
        This is a journey we have been on now for over 5 years,
    starting with our Benefit-Risk Framework we put in place for
    product approvals back in 2012, where we made a decision that
    we would explicitly make a factor in our decisionmaking to be
    patient preferences.
        The old way of saying that we take into account the
    tradeoffs our reviewers make is not what we should do. Devices
    are used on or in patients. And so, the tradeoffs they are
    willing to make are the ones that should factor into our
    decisionmaking. And MDUFA IV will help us advance that work.
        Ms. Castor. And you provide a few examples when a patient
    organization had some ideas and came to you and how it improved
    the situation or altered the situation?
        Dr. Shuren. Yes. So, one, I had mentioned this study we had
    done with obesity treatments. That has already led to now
    products coming on the market. We are looking to replicate that
    in other areas.
        The other thing patient groups have done--and we have set
    this up--is getting them to come in and speak to everyone in
    our Center. I believe every single person in CDRH needs to be
    interacting with patients. That is even our secretaries. So,
    when they answer the phone, they return an email, they
    understand the patient's perspective when they do so.
        So, last year we hosted 21 events for our staff in our
    Center, and 34 patient groups participated in that. We are
    establishing mechanisms where we now have, rather than just a
    network of scientific and engineering and healthcare
    professional experts which we set up, we have a network of
    patient groups, patient volunteers who are working with us.
         And then, the next stage this year is the official launch
    for our Patient Engagement Advisory Committee, where for the
    first time at the agency there is an advisory committee made up
    just of patient representatives to tackle the issues that
    matter most to them.
        Ms. Castor. Great. I appreciate your emphasis on that, and
    we will be following up with some more specific questions.
    Thank you.
        Mr. Burgess. The gentlelady yields back. The Chair thanks
    the gentlelady.
        I now recognize the gentlelady from Indiana, Ms. Brooks.
    Five minutes for questions, please.
        Mrs. Brooks. Thank you, Mr. Chairman, and thank you, Dr.
    Shuren, for being here.
        In the information you provided us in your written
    testimony, you talked about the diagnostics for national
    emergencies. I would like to focus a little bit on that because
    I have been focused here on trying to strengthen our public
    health infrastructure for national emergencies, but I have been
    more focused, along with Congresswoman Eshoo, on incentivizing
    vaccines and treatment for public health emergencies and
    pandemics. But I know from your testimony that, obviously, the
    diagnostic piece and the testing initially is so very critical,
    and I appreciate the rapid response that has been undertaken by
    FDA and applied the high volume of the emergency use
    authorizations granted and reauthorized.
        But, unfortunately, as we know, whether it was Ebola in
    2014 or, most recently, Zika virus in 2016, we know that FDA
    has focused significant time and resources to these
    diagnostics. But can you speak not just to what has happened in
    the last 5 years, but what can we anticipate going forward from
    CDRH? Because I know there is a lot of concern when we have
    these outbreaks, I know as we get ready to go into the warm
    season once again with Zika, we don't have vaccines yet. We
    don't have treatments.
        Can you please share with us with respect to national
    emergencies what your offices, what the focus is, whether or
    not the resources that we have been providing are sufficient?
    What more should we be doing?
        Dr. Shuren. Well, certainly on the device side for
    diagnostics, we have sort of invested in our infrastructure to
    try to best handle, when there is an emergency, that we have
    the capacity to be able to deal with new diagnostics that may
    be coming in. To date, we have already authorized about 50
    EUAs, and, also, in a fairly rapid time. You know, the median
    time to approve an EUA for Zika was about five days.
        Mrs. Brooks. Excellent.
        Dr. Shuren. The other thing that we do in these
    circumstances is we develop templates for the product
    developers that make it easier for them to be able to gather
    the evidence under that standard, get it to the agencies. So,
    again, this moves much more quickly.
        I would say the greatest challenge developers face today is
    more about access to samples and the clinical information
    linked to that sample. It is not under FDA's purview, but that
    is what we hear from the companies, because the samples help
    them design the technology and, then, validate it.
        More broadly, when we deal with these national emergencies,
    it is certainly an issue--I know your interest--I will take
    back, but it really is sort of a question about more on the
    national level, are we prepared as a nation? And I will ask
    this rhetorically, because I am not the one to answer it, but
    are we prepared as a nation when we have the next outbreak?
    Because there is going to be a next outbreak. As we see, we are
    just constantly bombarded with new organisms and things that
    really stretch our scientific knowledge and capabilities.
        Mrs. Brooks. Well, and thank you for that. It is
    reassuring, actually, to hear that it was only a five-day
    turnaround with respect to Zika.
        It kind of leads into my next question about global
    harmonization. If you say that you don't have enough samples,
    what kind of cooperation is there and what kind of
    harmonization is there between our partners in other countries?
    With their regulatory process and our own, how can we possibly
    work on that to help particularly with emergency use?
        Dr. Shuren. I know already that there is strong
    relationships between CDC, who normally handles that aspect,
    with other organizations internationally, like the World Health
    Organization. We certainly, then, work very closely with CDC.
    And when there are needs for making available more samples, we
    will also go to them and sort of encourage can we get and make
    those available to developers.
        Mrs. Brooks. So, you don't need authority beyond what you
    have to work with other regulatory bodies? You feel like you
    have sufficient authorities in place? Or is there anything that
    impedes your work with other regulatory bodies?
        Dr. Shuren. I think we have the authority we need for the
    kind of work we do. When you think more broadly in terms of the
    response, when we deal with samples and others, I would say
    that may be questions to direct to the other involved agencies.
    And certainly, that is something we will take back within HHS.
    If there are any additional needs that HHS feels are warranted
    for the other agencies, we will bring that back to you.
        Mrs. Brooks. Thank you for your work.
        I yield back.
        Mr. Burgess. The Chair thanks the gentlelady. The
    gentlelady yields back.
        The Chair recognizes the gentleman from North Carolina, Mr.
    Butterfield. Five minutes for questions, please.
        Mr. Butterfield. Thank you very much, Mr. Chairman. It is
    good to sit next to you. And thank you so much for calling this
    hearing today, and thank you for your friendship and thank you
    for your leadership.
        The medical device industry, Mr. Chairman, is important
    certainly to all of us, and including my constituents down in
    North Carolina, both in the Triangle area and in the eastern
    part of my State. Because this industry actually is a job-
    creator. They employ thousands of my constituents. But, also,
    because medical devices can help improve health outcomes and
    improve the quality of life for many lives of those suffering
    from complex medical conditions.
        My home State is home to many large and small medical
    device developers like CVRx, which I understand is on the next
    panel, which is represented here today. The advances made
    possible by the User Fee Agreement III, including increased
    communication with patient and consumer organizations is a step
    in the right direction. It is a step in the right direction for
    transparency and patient involvement in the process.
        Meaningful reforms included in the negotiated agreement for
    MDUFA IV will further advance those goals and stand to improve
    outcomes for patients. Specifically, the potential benefits of
    using real-world evidence to help develop medical devices can
    benefit my constituents and citizens throughout the country.
        Also, the proposed National Evaluation System for health
    Technology, known as NEST, can help ensure the use of real-
    world evidence is scientifically based and effective. There is
    great potential for this agreement to facilitate innovation and
    improve health outcomes. However, the potential can only be
    realized if the administration invests in the overall budget of
    the FDA, does not hamstring its mission through hiring freezes.
        Now, Dr. Shuren, I am going to ask you a couple of
    questions. I am going to ask you about the funding at the
    agency. I think we know the circumstances there. That is our
    jurisdiction. So, we are going to deal with that politically on
    this end.
        But I am very interested in the NEST proposal and the
    agreement. Can you discuss how stakeholders will be chosen to
    own and operate NEST? And will patient advocacy groups be
    included in that process?
        Dr. Shuren. Certainly. So, NEST, again, it is a
    nongovernment system; it is a nongovernment entity. And it does
    not own or control the data sources. It is setting up
    agreements and policies regarding use of data that may be
    owned, let's say, by healthcare systems or by a registry.
        We have already supported the creation of what we call a
    Coordinating Center. The Medical Device Innovation Consortium,
    a public/private partnership, is serving in that capacity. They
    now have put out a call for members of a governing committee
    that would be representative of the ecosystem. Patients will be
    represented on that governing committee. So, they are going to
    have a say in how NEST is run, and we are now in the process of
    hiring an executive director. MDUFA IV will provide additional
    support to now operate the Coordinating Center and invest in
    pilots.
        Beyond the governing committee though, the plans are to
    establish other forums for different communities. So, looking
    for beyond having those representatives from the patient
    community on the governing committee, forums for the patient
    community to engage directly with NEST and to have their input
    taken into account.
        Mr. Butterfield. Under the NEST proposal, what steps do you
    envision for bringing new devices to market?
        Dr. Shuren. Well, I think one of the critical is your
    device needs to be safe and effective, which you may
    demonstrate directly with high-risk devices or, you know,
    lower-risk ``me, too'' devices. It is substantial equivalence.
        But it is the science that drives that decisionmaking. And
    the question is, when you need clinical data, the cost to do a
    traditional clinical trial is very, very high. If you are able
    to leverage data that is already being collected, it is a good
    enough quality, and you can control for other biases, then that
    data can be leveraged to support that product coming to market
    in ways that let you gather the data more quickly and at lower
    cost. And that leads to technology not just getting to market
    more quickly, because the time to develop the evidence goes
    down, but the amount you have to invest to do it means you can
    put that money to develop other products.
        Mr. Butterfield. Running out of time, my last question,
    what steps do you envision for the expansion of indications for
    already approved devices under the agreement?
        Dr. Shuren. Again, being able to leverage those data
    sources may allow us to expand a labeling indication. And we
    have already done that, for example, in the case of a
    transcatheter aortic heart valve. The company was planning to
    do a clinical study to expand its indications. We looked at the
    registry data and said the data is already there; why don't you
    just ask us to expand the indication? So, what would have taken
    years took weeks.
        Mr. Butterfield. Thank you. I yield back.
        Mr. Burgess. The Chair thanks the gentleman. The gentleman
    yields back.
        The Chair recognizes the gentleman from Oklahoma, Mr.
    Mullin. Five minutes for questions, please.
        Mr. Mullin. Thank you, Mr. Chairman.
        Doctor, thank you for being here.
        During the series that we have been going through, we had a
    hearing about our generic drug user fee, and I got an
    opportunity to talk with Dr. Woodcock about the concerns we
    have heard from industries about the inconsistency with the FDA
    inspections. Companies are concerned about the lack of
    transparency, predictability, and efficiency, and consistency.
    And I hear that the inspections of foreign device
    establishments are often more efficient than domestic
    inspections. Have you heard about this?
        Dr. Shuren. Yes, I have.
        Mr. Mullin. Could you explain maybe what steps you are
    taking to make sure that there is consistency through standard
    operating procedures?
        Dr. Shuren. So, we are working with our Office of
    Regulatory Affairs, who is actually responsible for the field
    staff. It is true that domestic inspections may take longer
    than foreign inspections.
        Mr. Mullin. Why is that?
        Dr. Shuren. So, for foreign inspections, they are making
    arrangements for that inspector to go over for that inspection.
    So, that is all they are there for. They come back.
        On the domestic side, that inspector may be finishing up
    with another inspection or they get called away for a for-cause
    inspection. That said, on average, most domestic and foreign
    inspections occur in four days or less, sometimes within one
    day. But I do know that ORA--and we are working with them as
    part of this program alignment effort--is revisiting its SOPs,
    so that it reduces the time for domestic inspections.
        I think folks understand it can be disruptive to companies.
    Someone comes in the door, they leave, they come back, rather
    than they come in and they finish their work, they are done,
    and they move on.
        Mr. Mullin. So, paraphrasing what you said, the issue we
    are having here domestically versus foreign is that they are
    distracted?
        Dr. Shuren. Is? Excuse me?
        Mr. Mullin. They are distracted?
        Dr. Shuren. That they may be doing more than----
        Mr. Mullin. Well, I mean, what I am saying is that they can
    go over there and they can focus on one task. And when they are
    here, they are focusing on 15 or 20 different tasks?
        Dr. Shuren. Well, not from 15 or 20, but when they----
        Mr. Mullin. Two or three, four or five?
        Dr. Shuren. Maybe or they may be focused on the one. Like I
    said, most of the time they are doing that inspection in just a
    few days.
        Mr. Mullin. Do the same individuals inspect foreign and
    domestic? Or do you have a certain group that only does foreign
    and a certain group that only does domestic?
        Dr. Shuren. As of right now, there are some individuals
    who, a very small number, who do primarily foreign, but many of
    them are people who do domestic and foreign.
        Under the program alignment effort, part of that effort is
    to move away from the other challenge, which is inspectors who
    they not only inspect a device company, they inspect a food
    company and a drug company. Program alignment is to establish
    these more vertical commodity-specific programs, so you just
    have a device inspector and that is all they do. And that will
    allow them to also better focus and have the right expertise
    and training. And that will start to drive greater consistency
    and more timeliness in the conduct of----
        Mr. Mullin. How long do you think these changes are going
    to be implemented?
        Dr. Shuren. To be fully up and running, it will take a few
    years. As of in a few weeks, that official program will be
    stood up in the various commodity areas, and over the next two
    to 3 years most of the pieces will be in place.
        Mr. Mullin. I guess help me understand why 2 or 3 years.
    What is going to take so long to make the changes?
        Dr. Shuren. In part, because ORA is responsible for all the
    product areas. So, they are not just dealing with medical
    devices. They have their program for pharmaceuticals, for human
    food. So, they have to handle all of those, and it is, in part,
    the huge workload ongoing from people are geographically
    oriented in an organization and now is focused within a region
    instead, to say, I have a national organization where people
    may be in different places, but we run it centrally. They got
    to standardize the training. They have got to change their
    standard operating procedures. The systems have to be, the IT
    systems have to be changed. There is just a lot of work that
    goes into it.
        Mr. Mullin. And I completely understand everything you are
    saying. I just can't wrap my head around, when we see that
    there is already issues going on, why it would take roughly 2
    or 3 years after the program is stood up to fully implement it.
    I would like to think there is a more efficient way for us to
    be able to get that implemented than its taking 2 or 3 years.
    Because once you issue the SOPs, then it is just a matter of
    people willing to do their job and the training that it is
    going to take to get it. I mean, if they have already been in
    that field to some degree, then we are moving distractions away
    and it seems like they could be able to be more focused on just
    the job at hand.
        And I say that because I get implementing changes in a big
    organization, that it can take time to turn the ship around.
    But our companies are struggling, which means that our
    consumers are struggling, which means that we have rising
    costs, and, eventually, it gets passed down to the ultimate
    person that we are here all trying to help prevent higher costs
    and get the drugs needed to the individual that needs it, the
    patient.
        So, if there is a way that we can help through this
    process, as I offered my help to Dr. Woodcock, I would offer it
    to you, too. Any way that I can help, this committee can help,
    or our office can help, we want to be helpful because this is
    important.
        Thank you, sir.
        I yield back.
        Dr. Shuren. Thank you. And I will just say, you are
    preaching to the choir because having better consistency and
    being able to deal with just a set of individuals, that is
    easier for my Center as well. So, I will take this back.
        And I do know, when they stand up the program, the program
    is organized, but they still have to do all the training and
    the SOPs. That work is yet to come.
        Mr. Mullin. And I will say your sincerity comes through,
    through body language and tone. So, I really appreciate that.
        Mr. Burgess. The gentleman yields back. The Chair thanks
    the gentleman for his questions.
        The Chair recognizes the gentlelady from California. Five
    minutes for questions, please.
        Ms. Matsui. Thank you, Mr. Chairman, and thank you for
    holding this hearing today.
        And thank you, Dr. Shuren, for being here also.
        This is the last of three hearings on the User Fee
    Agreements negotiated between FDA and industry. I am glad that
    all parties are satisfied with the outcomes, and I think we
    have all worked together to ensure that FDA has the resources
    it needs to continue making sure that drugs and devices are
    safe and effective for America's consumers.
        I am particularly pleased with provisions in the User Fee
    Agreements that will benefit the rare disease patient
    community. In MDUFA, this includes increased patient
    engagement. This is perhaps more tangible with medical devices
    because the size and convenience of a medical device directly
    impacts patients' quality of life, even if it doesn't
    necessarily affect a device's effectiveness. Similarly, I think
    the additional real-world experience evidence and data will
    help incorporate the patient experience in a quantifiable way.
        Dr. Shuren, can you talk about how additional patient
    engagement, as well as real-world evidence through the NEST
    program, will help advance devices for patients with rare
    diseases?
        Dr. Shuren. Well, first, I fully agree with you that those
    two pieces will be important for rare diseases. You know, one
    of the challenges is gathering information and evidence to
    support that that device, in fact, meets the standard for a
    rare disease coming on the market. And it can be very hard to
    get the patients enrolled and in studies. But, if we are able
    to leverage data that may be part of their routine care, then
    we can maybe get that evidence and help bring those products to
    market and to do so in less time and lower cost.
        And by the same token, too, we should be measuring the
    things that really matter most to patients. When we decide is
    the evidence sufficient, because there is always going to be
    uncertainty in the evidence on benefit and risk, then for
    patients and often with rare conditions, they are willing to
    accept more uncertainty for treatment. And so, we need to be
    willing to accept that uncertainty, too. I think that will
    help.
        The last plug I will put in is I think 21st Century Cures
    is going to help patients with rare disorders as well,
    broadening the definition of what constitutes a rare disorder
    for purposes in medical devices. So, again, thank you to the
    subcommittee for that.
        Ms. Matsui. Thank you very much.
         Many patients use medical devices every day, everything
    from surgical plants like knee replacements or pacemaker to
    wound care technology, to lab and diagnostic equipment. In
    recent years, we have seen some headlines about equipment that
    ends up contaminated or defective. This is generally a post-
    market problem, meaning that the devices themselves are safe
    and effective, but that something happens at the facility or a
    hospital that compromises that.
        While I understand that MDUFA is meant to address only pre-
    market issues, I think that post-market review is an important
    part of what FDA does to keep us safe. In fact, it is a good
    reason to keep funding FDA using appropriated dollars and not
    just user fees.
        Dr. Shuren, I would like to ask about the NEST program and
    how the incorporation of post-market clinical data, such as
    patient registries, may help ensure that devices are safe and
    effective throughout their life cycle.
        Dr. Shuren. Well, while in the MDUFA agreement, the
    commitment letter, we talk about pilots that are primarily pre-
    market, that is because, for purposes of the user fee
    reauthorization, we have to stay within the confines of the
    scope of MDUFA. However, NEST is operated by the independent
    Coordinating Center, and they can and are planning to also look
    more broadly in terms of leveraging for post-market safety. And
    it can address two of the challenges we have today.
        First off, for post-approval studies, we know that
    patients, once a device has been approved, lack incentives to
    enroll in clinical trials. So, clinical trials, often they may
    not get conducted; they may not get finished. In fact, we are
    making phone calls now on some of our 522 studies to encourage
    people, hospitals and practitioners, to enroll patients. But,
    if that data is being collected like in a registry, as we are
    finding today, then we get that data and we get it in a more
    timely manner. That is great for the company. It is great for
    patients. It is great for us.
        The other is today, for safety problems, we often rely on
    adverse event reports. That means somebody had to identify that
    a problem occurred and may be associated with a device and take
    the time to report it. And there are a lot of things. You may
    get information that is not right.
        Now, when we move toward larger datasets that will allow us
    to use software tools to try to look for are there particular
    problems and, then, do a deeper dive on it, that ultimately
    enhances patient safety and reduces liability for companies.
    That is a win all around.
        Ms. Matsui. Well, thank you, Dr. Shuren.
        And I yield back.
        Mr. Burgess. The Chair thanks the gentlelady. The
    gentlelady yields back.
        The Chair recognizes the gentleman from Georgia, Mr.
    Carter. Five minutes for questions, please.
        Mr. Carter. Thank you, Mr. Chairman.
        And thank you, Dr. Shuren, for being here. We appreciate
    it.
        I am from the State of Georgia. We have got quite a few
    medical device companies in our State, as well as the CDC. So,
    I appreciated your comments earlier about the relationship with
    the CDC and how you work closely with them. That is very
    important, and we are very proud of the work that they do for
    our country, located right there in the State of Georgia.
        I want to ask some basic questions. OK? I am not going to
    go by my notes that my staff provided me. They do such an
    outstanding job. But I just want to ask you something.
        I am new to the committee. As I understand this process, it
    is somewhat of a process that is just kind of a speeding-up
    process, if you will, that manufacturers, the medical device
    companies, agree to pay if they can help to get the process
    sped up. Am I correct in saying that?
        Dr. Shuren. That has been a main focus without jeopardizing
    the quality of----
        Mr. Carter. And that is what I want to ask you. I want to
    ask you--and I want your true opinion here--have there been
    instances where you have looked back and you have said, ``Gee,
    I wish we would have slowed down some. I wish we would have
    done something else.''?
        First of all, have there been any recalls of devices that
    were approved that, through this process, through the MDUFA
    process, have there been any recalls?
        Dr. Shuren. Yes.
        Mr. Carter. OK. In those instances, have you asked
    yourself, you know, had we slowed down some, would this have
    happened?
        Dr. Shuren. I don't believe so. That has not come up. And
    again, the way the goals are designed, it is also it is not 100
    percent. So, we know, too, if we need to take additional time
    to make a decision, then we will do it in the individual case.
    I think, if anything, if there isn't enough time, the pressure
    is, then, we are going to say no if there are issues. But the
    way they are designed is that it gives us flexibility that a
    percentage may go a little bit beyond the timeframes. And so,
    if we do need to take additional time, we will take the
    additional time.
        Mr. Carter. OK. Well, in those cases where there was a
    recall, I am sure you went back--I would hope you did--and
    reviewed what you did and said, could we have done anything
    differently to have prevented this?
        Dr. Shuren. So, we do take a look, what was the cause for
    the recall? Was it something that maybe we should have picked
    up when we were doing review? Most of the things are a lot of
    times issues that either come up after the product is on the
    market. Or anytime you review a product and you have the
    evidence, you don't have 100 percent certainty on the true
    benefit/risk profile of that technology. You would have to
    study it so in-depthly, you would never get a single product
    out there on the market.
        And sometimes, with more use, you find out there may have
    been some issue in the design that could affect performance,
    and we need to deal with it post-market.
        Mr. Carter. OK. Let me shift gears here for just a second.
    The President has made it clear that he wants to cut down on
    regulations. Earlier you heard someone say his Executive Order;
    you are aware of it. You know, for every new regulation that
    you pass, you have got to cut two.
        If, indeed, this President is cutting back, and if, indeed,
    as I hope we do cut back on a lot of regulations, isn't that
    going to cut back, if you don't have to follow as many
    regulations, are you going to have to have as many people? Are
    you going to have to have as much of a staff? I mean, should we
    reauthorize this for 5 years in anticipation of you having the
    staffing levels that you have right now for the next 5 years?
        Dr. Shuren. So, our workload, first of all, continues to go
    up. We have seen that. One of the most popular programs is our
    pre-submission meetings. That has been going up, like requests,
    by about 10 percent a year. And we are seeing more of the
    innovative medical device submissions come in the door.
        Part of MDUFA IV is a recognition that the program needs
    additional funding just to keep pace with the work we currently
    have, as well as strategic investments in programs like patient
    engagement and real-world evidence that can help enhance and
    speed access to safe and effective devices.
        Mr. Carter. OK. One last question. I am a pharmacist,
    currently the only pharmacists serving in Congress. A lot of
    the clinical tests that we sell in the drugstores, they are
    very important to me to make sure that what I am selling to a
    patient is actually legitimate. And I know this is, from what I
    understand--and again, I am new member of the committee--but,
    from what I understand, this has been somewhat of a debate
    within the FDA about what role they should play in approving
    some of these.
        I will tell my age here. There was a time when I sold Drano
    in my pharmacy and it wasn't to unclog drains. For those of you
    who don't know, before we had gender tests, that is the way a
    lot of people tested to see if they were having a boy or a
    girl. That is folklore.
        So, I guess my question is, I know that is a big, big
    discussion about the FDA's role in approving some of these. And
    I didn't know if you had an opinion on that or not.
        Dr. Shuren. So, our perspective has been that tests,
    regardless of what is out there, you want tests that are simply
    accurate, reliable, and clinically meaningful. And that is just
    good for our patients. It is good for healthcare practitioners.
        Mr. Carter. Are all of them coming through you? Are you
    approving all of them? I mean, we had the situation with
    Walgreens and fairness and some of the tests that were being
    sold there.
        Dr. Shuren. No, they don't all come through us.
        Mr. Carter. Do you think they should?
        Dr. Shuren. Well, I think that issue is one that we know is
    of great interest to many Congressional Members, to
    stakeholders, and it is a topic that we will talk about with
    our colleagues at HHS. We haven't had that conversation yet.
    So, I am just not in a position now to talk about it.
        Mr. Carter. Right. Well, I appreciate it very much.
        Thank you, Mr. Chairman. I appreciate your indulgence.
        Mr. Burgess. The gentleman yields back. The gentleman's
    time has expired.
        The Chair recognizes the ranking member of the full
    committee, Mr. Pallone of New Jersey. Five minutes for
    questions.
        Mr. Pallone. Thank you, Mr. Chairman.
        Dr. Shuren, let me ask--and I think I said some of this
    before--but the Medical Device User Fee Amendments, or MDUFA,
    was first established in 2002. Prior to that, the medical
    device program was suffering from long-term loss of resources,
    lag in medical device review timetables, out-of-date guidance,
    and a lack of expertise among FDA personnel. And MDUFA has been
    a success in addressing these issues, reducing the average
    total time to a decision on a pre-market approval in 2015 by 35
    percent over 6 years, and for a 510(k) in 2015 by 11 percent
    over 5 years. And I understand that in 2016 FDA approved 91
    novel devices, the highest since the creation of MDUFA.
        As you know, the statute outlines a detailed process for
    reauthorization that requires FDA to not only negotiate with
    industry to develop recommendations, but also to solicit public
    input, hold public meetings, consult periodically with Congress
    and patient and consumer groups, among others. The
    recommendations that are the result of this process must also
    be available publicly for a period of public comment and,
    ultimately, are required by statute to be transmitted to
    Congress.
        So, can you discuss further the process FDA undertakes to
    prepare recommendations for reauthorization of the User Fee
    Agreements and, in particular, the timeline for these
    activities?
        Dr. Shuren. We will quick establish a team, an interagency
    team. We have senior leadership for the agency that provides
    strategic direction and advice. We engage in discussions with
    the device industry. Usually, start-to-finish, when we first
    sit down to when a package comes to Congress is about 18
    months. Along the way, we have a public meeting in the
    beginning; at the end, opportunity for public comment on the
    proposed package. And we also have monthly meetings with
    patient and consumer groups. So, a very interactive, thoughtful
    process.
        Mr. Pallone. I thank you.
        So, you mentioned that if we do not reauthorize MDUFA by
    September 30th, CDRH would lose about one-third of its
    personnel. Can you discuss further the types of positions and
    personnel that would be subject to RIF notices?
        Dr. Shuren. Physicians, nurses, engineers, a whole variety
    of scientists from, you know, biologists, physicists, chemists.
    It will run the gamut.
        Mr. Pallone. OK. Now the User Fee Agreements between FDA
    and industry are the end result of many months of negotiations
    which are submitted to Congress after careful consideration of
    public comments and consultation with patients and consumers.
    And there are very real implications in terms of patient access
    to treatments and the personnel at FDA if Congress doesn't
    authorize this program before it expires on September 30th. And
    I am committed to working with my colleagues across the aisle
    and across the Capitol to ensure that we meet this deadline.
        But I wanted to ask you, also, Dr. Shuren--and I know we
    are running out of time--FDA has increasingly focused on
    shifting data from the pre- to post-market setting for devices
    to facilitate innovation. However, central to this approach is
    an assurance that FDA and manufacturers will have the data they
    need to detect safety problems that are harming patients. FDA
    envisioned the creation of the National Evaluation System for
    health Technologies, or NEST, to help collect the information
    using electronic health records, registries, and claims data.
    There is already considerable progress and momentum in adding
    unique device identifiers to EHRs, and there are now positive
    steps in adding unique device identifiers to health insurance
    claims data.
        So, speaking specifically to adding unique device
    identifiers in health insurance claims, what are the benefits
    unique to the incorporation of device identifiers to claims
    data from which FDA researchers and others can benefit?
        Dr. Shuren. Well, one of the challenges with some of the
    other data sources like registries is they collect data on a
    patient for a short period of time. Claims data would allow us
    to have more long-term information on that patient, what is
    happening to them with the medical device. In some respects,
    linking up the claims data with other data sources, then,
    becomes a rich bod of evidence to use.
        Mr. Pallone. OK. I actually didn't run out of time. Thank
    you, Mr. Chairman.
        Thank you, Dr. Shuren.
        Mr. Burgess. The Chair thanks the gentleman. The gentleman
    yields back.
        The Chair recognizes the gentleman from Florida, Mr.
    Bilirakis. Five minutes for questions, please.
        Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it
    very much.
        Dr. Shuren, in the 21st Century Cures Act, we were able to
    pass reform language to modernize the Office of Combination
    Products. As you know, combination products are products on the
    market that have elements of a medical device and a drug, like
    inhalers or insulin injectors. Many patients need and rely on
    combination products.
        While we worked on the 21st Century Cures, I asked FDA
    about the innovation in the drug and device space, as more and
    more innovative products may be combination products. At the
    time, there were complaints from innovators about the slow and
    burdensome FDA process for approving combination products. At a
    hearing, you stated that this problem with combination products
    was a place that does require probably further discussion, and
    whether or not there are changes to be thought about it to make
    that intersection work better than it currently does.
        I was able to have language in the 21st Century Cures,
    again, to address some of these problems with combination
    products. Can you update us on what the FDA is doing on the
    device side to implement the Cures language for combination
    products and what was agreed to in the Medical Device User Fee
    Agreement?
        Dr. Shuren. So, first off, let me say thank you for that
    provision, and I think it will be important, helpful in the
    work that we do on combination products, which we agree
    increasingly are becoming more and more important in our health
    care.
        So, we are working. The agency has an interagency group,
    first off, coordinated on implementation. We are a part of that
    group, and we will be engaged in the various pieces that have
    to be implemented for combination products.
        We have also, prior to that, set up a Combination Product
    Policy Council that already started to make improvements in how
    we handle combination products. For starters, we have had a
    pilot underway that will be a full-fledged program very soon on
    streamlining consults between the involved centers, so that we
    are better working together, let's say us and our Center for
    Drugs and our Center for the Biologics. So, again, getting the
    right expertise in a timely manner to facilitate those reviews
    of combination products.
        Mr. Bilirakis. Very good. Thank you.
        This question is a little bit outside the full scope of
    FDA. But what are the challenges that patients wrestle with for
    the coverage of FDA-approved medical devices? I have had
    conversations with doctors and patients who wanted to get an
    FDA-approved medical device, but CMS hasn't approved that
    device for coverage.
        CMS lack of coverage for PET scans, for example, for
    Alzheimer's diagnosis is, again, one example of backwards-
    thinking from Medicare. There are a number of FDA-approved
    medical devices that CMS has been slow to cover.
        I know that FDA was working with CMS on these types of
    payer issues with the Parallel Review Program. Can you update
    us on where things stand with your work with CMS and other
    payers? Do we see a reduction in devices getting covered? Do
    you have any metrics or data on how things have changed or
    improved?
        Dr. Shuren. Well, this is an area we have devoted a lot of
    time and attention to because true patient access isn't just a
    technology on the market. Particularly for our more expensive
    technologies, if there isn't adequate reimbursement, then
    patients don't have real access to it.
        That said, CMS and payers operate under a different
    standard that is appropriate for payers versus a regulator like
    us. So, we have been working with CMS and others, how do you
    streamline that pathway to market, and from market to coverage
    reimbursement?
        You mentioned Parallel Review, and that started as simply a
    process change, so that CMS could start engaging on a national
    coverage decision before we had approved the product. What we
    have now made available is, for interested companies, and on a
    voluntary basis, and if CMS and we agree, they can come and
    talk to us before they have done their big pivotal clinical
    trial, so that they can design their evidence generation to
    meet the needs, the standards for FDA and the standard for CMS.
    And we have had some interest, and one product, in particular,
    went through that and probably saved 2 years for their time to
    ultimately get reimbursement.
        We have been working with CMS also about can we better
    leverage real-world evidence. This case of transcatheter aortic
    heart valve replacement, when we first approved it, we worked
    with two healthcare professional societies on setting up a
    registry and with CMS. So, when we approved that device,
    Medicare covered it under a coverage with evidence development
    decision. And now, every time we approve a new indication, it
    is automatically covered by Medicare, which is different than
    many other countries.
        The other thing we have done is set up a similar
    opportunity with private payers. Again, if a company would like
    to do it and the payer would like to do it, we are happy to
    have a meeting and share what our respective needs may be.
        Mr. Bilirakis. Very good. Thank you, Doctor.
        I yield back. Thank you, Mr. Chairman.
        Mr. Burgess. The Chair thanks the gentleman. The gentleman
    yields back.
        The Chair recognizes the gentlelady from Illinois, Ms.
    Schakowsky. Five minutes for questions, please.
        Ms. Schakowsky. Thank you, Mr. Chairman.
        I want to thank you, Dr. Shuren, for being with us today.
        Over the past few months, I have become increasingly
    concerned with the safety of two defibrillators manufactured by
    St. Jude Medical, which was recently acquired by Abbott. This
    issue first came to my attention when a staff member of mine
    was forced to undergo surgery to have her St. Jude
    defibrillator replaced because her device was no longer working
    properly. This is a young woman who has a congenital heart
    condition.
        Last October, FDA released a safety communication regarding
    battery depletion for two of St. Jude's devices. At the time,
    two patients had died as a result of this faulty device and
    another 47 had reported dizziness or fainting. The rapid
    draining of a battery can happen in a matter of days, leaving
    patients with little time to rectify this issue before facing
    possibly grave consequences.
        Then, in January, FDA released another communication
    detailing a possible cybersecurity threat for these same
    devices manufactured by St. Jude's Medical. Given the severity
    of these issues, I am very concerned for patients with these
    devices.
        In addition, I am appalled that patients are left to figure
    out how to pay for the required surgery to replace the device,
    despite finding themselves in that circumstance through no
    fault of their own.
        Finally, it is concerning that in some cases patients will
    learn about the problems with their device in the news before
    hearing about it from their doctor.
        So, Dr. Shuren, how are patients notified when there are
    problems with their device, and how does the FDA ensure that
    patients are given this information in a timely way? And if the
    safety communication is given to doctors, how do you ensure
    that doctors are communicating that information to patients?
        Dr. Shuren. First of all, let me say that I am sorry to
    hear about what happened with your staffer.
        In terms of communications, while we can't compel
    physicians to tell their patients, what we do is we put out
    information like with the safety communication, put it up on
    our Web site, but, then, we push it out to other organizations
    who push information or where healthcare professionals and
    patients get their information. Also, one of the reasons you
    will see it in newspapers is because patients get their
    information from the news. So, we push it out to those news
    services as a way of getting into patients, since, otherwise,
    it is hard for us to reach into people's homes to get it there.
        And then, we try to provide the best information possible
    for both patients and healthcare professionals to make the best
    informed decisions that is right for their particular care.
        Ms. Schakowsky. Let me ask you--I have a few more
    questions--how is the FDA notified of these problems in the
    first place? Do you rely on the device manufacturer to report
    any issues?
        Dr. Shuren. So, sometimes we hear from the device
    manufacturer. We get adverse event reports. We get complaints.
    We can go in the door, conduct an inspection. We may identify
    problems. There is a lot of tools that we have.
        Ms. Schakowsky. Are they required, though, however, the
    manufacturers, are they required, if they discover a problem,
    to report it?
        Dr. Shuren. If they discover a problem of that kind of a
    serious nature, then, yes, they would be contacted.
        Ms. Schakowsky. And did St. Jude's?
        Dr. Shuren. We did have conversations with St. Jude and we
    have been working with St. Jude on the steps to take to address
    those two particular issues.
        Ms. Schakowsky. How does the FDA plan to improve their
    post-market surveillance system, to improve notification of
    problems with medical devices, and to better track cases of
    patients who have been impacted by faulty devices?
        Dr. Shuren. Yes. So, first off, in terms of better
    communication out, there are certain tools--there is a
    limitation of the tools that we may have, but our healthcare
    system may start driving that more and more. I have seen
    increasingly patients having access, if you will, to their own
    record and healthcare professionals communicating directly to
    them. Even my wife just had that instant messaging between her
    and her treating physician.
        In terms of how we have a better sense of patients who are
    affected, NEST is one of those areas that can help how we are
    better able to leverage data that is out there that is being
    collected on patients. Including a unique device identifier in
    like electronic health records will make it easier for us to
    link the specific device that is being used that may be subject
    to a recall, let's say, with the patients who get them.
        But, that said, it is absolutely critical----
        Ms. Schakowsky. Let me ask about a recall. So, if a device
    manufacturer continues to manufacture defective devices or has
    an ongoing recall or safety notification, what tools or
    authority does FDA have available to ensure patient safety?
        Dr. Shuren. So, we have a variety of enforcement tools. The
    first thing we will do with the company is will they work with
    us to resolve the problem. So, in a recall, most of them are
    voluntary because, if we contact the company and they work with
    us, we can address that problem much more quickly than if we
    went with an FDA-mandated recall, which is going to take a lot
    more time.
        If a company is not working with us, then we may move to a
    variety of steps. There may be a warning letter if products
    shouldn't be on the market. We may have an injunction. We may
    have a seizure. If there are issues more broadly with the
    company, we may put them under a consent decree.
        Ms. Schakowsky. Thank you. I yield back.
        Mr. Burgess. The Chair thanks the gentlelady. The
    gentlelady yields back.
        The Chair recognizes the gentleman from Missouri, Mr. Long,
    for 5 minutes for your questions, please.
        Mr. Long. Thank you, Mr. Chairman.
        And, Dr. Shuren, there are a number of commitments in this
    agreement that complement provisions in the 21st Century Cures.
    Can you highlight a few of these provisions and speak to
    whether FDA would be able to implement them if Congress did not
    reauthorize this User Fee Agreement by September?
        Dr. Shuren. So, there are several provisions in there on
    patient engagement in MDUFA IV and real-world evidence. While
    the complementary provisions in 21st Century Cures do not apply
    to devices--they are focused on drugs--we consider them
    important and they dovetail with what Congress would like to
    see more generally.
        I think as well the provisions on clinical trials and their
    moving from local IRB to a central IRB is going to help speed
    the conduct of clinical trials that are going to support coming
    through market and review under the User Fee Program. I think
    some of the clarity around valid scientific evidence also is
    related to the work that we do under the User Fee Program. The
    same for combination products because those two are subject to
    the User Fee Program. So, I see lots of synergy between 21st
    Century Cures and MDUFA IV.
        In terms of what happens if we are not able to reauthorize
    MDUFA IV, then we are going to lose a third of our staff
    immediately. We will see more that leave afterwards, and we
    will not be able to make good on not only our current MDUFA
    commitments, which would all sunset, but just running the
    program to do anything is going to be challenging.
        Mr. Long. Several consumer groups have raised concerns that
    the use of real-world evidence could ultimately result in FDA
    approving products based on insufficient clinical data. Can you
    please address those concerns?
        Dr. Shuren. No, I don't think either MDUFA IV or anything
    else that has come on the table is going to adversely impact
    the data that we are able to rely on to make informed
    decisions. So, for example, real-world evidence, part of this
    is looking at the pilots not only for setting up the program
    and looking at return on investment, but nothing says that we
    have to accept a particular data source.
        Mr. Long. OK.
        Dr. Shuren. That evidence still has to be relevant to the
    question. It has got to be sufficiently reliable for us to make
    a decision. So, this doesn't change any of the standards on
    which we make decisions. It doesn't change what we will expect
    to have adequate evidence to make a decision.
        Mr. Long. OK. Thank you for being here and thank you for
    your testimony today.
        Mr. Chairman, I yield back.
        Mr. Burgess. The gentleman yields back. The Chair thanks
    the gentleman.
        Just a note. We will be going immediately to the second
    panel after the conclusion of Dr. Shuren's questions.
        Now I would like to recognize the gentleman from New
    Jersey. Five minutes for questions, please.
        Mr. Lance. Thank you very much, Mr. Chairman.
        Good morning to you, Dr. Shuren.
        I understand that in the most recent MDUFA Quarterly Report
    FDA's total time metrics to review pre-market approval devices
    is rising. This is not the direction any of us wish to see
    things go. Do you know what is behind the increase and what
    sort of tools are included in the new MDUFA agreement that
    might help prevent these sorts of total time increases in the
    future?
        Dr. Shuren. Yes, we have seen a small uptick, but we are in
    the process of looking into it. We are looking into a variety
    of factors. One I had mentioned is the increased workload we
    saw in MDUFA III, particularly, for example, submissions from
    some of the most innovative technologies.
        So, on the one hand, we are seeing more innovative
    technology come to the U.S. That is a good sign. It also means
    the workload goes up with it, and that might be one of the
    contributors. But we will have a better sense in the coming
    weeks.
        I think MDUFA IV is going to help in terms of providing
    more resources for the people that we need for doing the work,
    to enhance some of our IT systems, to establish a quality
    management system which also can drive greater efficiencies,
    and other steps that I think will drive greater consistency as
    well in our work. And all of that will help us have a better-
    running program.
        Mr. Lance. Thank you very much, Doctor.
        I have heard from many device companies that the pre-
    submission process has been a positive addition. It was
    established in the previous MDUFA agreement, and that it helps
    improve consistency and predictability in the device review
    process.
        Doctor, would you please explain what the pre-submission
    process is and how the next MDUFA agreement will improve upon
    it?
        Dr. Shuren. So, pre-submission process is an opportunity
    for a company to request to meet with the agency to have
    specific questions answered. You know, traditionally, a lot of
    times this is around what evidence do they need to bring a
    product to market.
        What MDUFA IV will do is it puts in performance goals for
    the timing of those meetings. It would have us commit to
    provide answers to the questions that are being asked at least
    five days before the meeting. And then, a company may be, ``You
    know what? We don't even need to meet.'' Or we can meet, but we
    will have a better-informed discussion because we already got
    feedback from the Center.
        Mr. Lance. Thank you very much, Dr. Shuren.
        And, Mr. Chairman, I yield back 2 minutes, 34 seconds.
        Mr. Burgess. The Chair thanks the gentleman for his
    generosity. The gentleman yields back.
        Dr. Shuren, this was not a plant, I guess, but on Gene
    Green's desk was a printout of the Houston Chronicle from I
    guess this morning, today's Houston Chronicle. And you were
    asked the question about what is on the horizon, and you
    mentioned robotics; you mentioned minimally invasive surgery.
    So, you are on the front page of the Houston Chronicle, where,
    after all, heart surgery was invented, right, Mr. Green? Well,
    maybe not, but maybe a little bit of poetic license. I went to
    medical school in Houston, so I have got a lot of affection for
    the city.
        But there is an article on the front page about doing just
    what you talked about, replacing an aortic valve through a
    tiny, little incision in the chest, and sparing that patient
    what used to be a much more major operation just to expose the
    operative field in order to replace the valve. So, it is really
    a game-changer, really groundbreaking, and we have been part of
    it this morning, for which we are all extremely fortunate.
        Mr. Green. Mr. Chairman, since you mentioned that, you
    know, Dr. DeBakey and Dr. Cooley, who have since passed away,
    but they set--for heart surgery, it is just amazing in the
    Texas Medical Center, one at Baylor College of Medicine,
    another one at University of Texas, the Health Science Center
    there.
        So, thank you. Thank you for that plug.
        Mr. Burgess. Again, Dr. Shuren, seeing no other Members
    wishing to ask questions, we are going to conclude this portion
    of the hearing. As we transition to our second panel of
    witnesses, Dr. Shuren, especially we want to thank you for
    spending so much time with us this morning, for being willing
    to come back to our committee, our subcommittee, and give us
    the current update on the Medical Device User Fee Agreements.
        Again, I would just stress that we all look forward to
    having that accomplished, and I realize there may be people who
    talk about improvements along the way. We welcome that
    discussion. But, make no mistake about it, we are going to get
    our work done, and we will have it done in a timely fashion.
        So, thank you much, Dr. Shuren, for your time this morning.
        And we will go immediately to our second panel who I will
    introduce in just a moment.
        Dr. Shuren, you are excused. Thank you.
        And again, as we transition to our second panel, I want to
    thank our second panel of witnesses for being here with us
    today and taking time to testify to the subcommittee on this
    important topic.
        As a reminder, each witness will have the opportunity to
    give an opening statement, followed by questions from Members.
        Our second panel of witnesses today include Ms. Cynthia
    Bens, vice president of public policy for the Alliance for
    Aging Research; Mr. Robert Kieval, founder and chief
    development officer at CVRx; Mr. Patrick Daly, president and
    CEO of Cohera Medical, and Ms. Diane Wurzburger, executive,
    Regulatory Affairs, U.S.-Canada Global Strategy, Policy, and
    Programs at GE Healthcare.
        We appreciate all of you being here with us today. We thank
    you for your forbearance during the first panel.
        And we will begin this panel with you, Ms. Bens, and you
    are recognized for 5 minutes for an opening statement, please.

    STATEMENTS OF CYNTHIA A. BENS, VICE PRESIDENT OF PUBLIC POLICY,
     ALLIANCE FOR AGING RESEARCH; ROBERT KIEVAL, FOUNDER AND CHIEF
     DEVELOPMENT OFFICER, CVRx, PATRICK DALY, PRESIDENT AND CHIEF
       EXECUTIVE OFFICER, COHERA MEDICAL; AND DIANE WURZBURGER,
     EXECUTIVE OF REGULATORY AFFAIRS, GE HEALTHCARE, ON BEHALF OF
               THE MEDICAL IMAGING & TECHNOLOGY ALLIANCE

                      STATEMENT OF CYNTHIA A. BENS

        Ms. Bens. Mr. Chairman, Ranking Member Green, and members
    of the subcommittee, it is an honor to speak to you today about
    the reauthorization of the Medical Device User Fee Program on
    behalf of the Alliance for Aging Research.
        The Alliance is the leading nonprofit organization
    dedicated to accelerating the pace of scientific discoveries
    and their application to improve the experience of aging and
    health.
        Right now, approximately 10 percent of the U.S. population
    is age 80 or older. This 80-plus age group will triple by 2050.
    Many older adults are fortunate to experience better health as
    they age than the previous generation. But the truth is that
    most older adults still face significant periods of disability
    and illness later on life.
        The develop one or more forms of cardiovascular disease,
    cancer, diabetes, bone and joint degeneration, muscle wasting,
    vision and hearing loss, neurological diseases, and
    incontinence. In our view, the need for innovative medical
    devices that help diagnose and better respond to the physical
    declines people face as they age have never been greater.
        And we believe we will only realize the benefits of these
    medical technologies if the FDA has access to the resources and
    expertise necessary to evaluate them, the medical device
    industry is certain that their products are going to be
    assessed in a timely manner, and, most importantly, that
    patients are at the center of new product development.
        Thanks to you and your colleagues in Congress, the Alliance
    and other groups were represented throughout the patient/
    consumer/stakeholder consultation phase leading up to the third
    reauthorization of MDUFA. We had two goals for MDUFA III, and
    we are pleased to report that both were achieved.
        The first was to make sure that CDRH had sufficient
    resources to conduct timely reviews, and the second was to
    secure support for a process through which CDRH would include
    patient fees on the benefits and risks of devices during their
    product reviews.
        MDUFA III allowed for the application of user fees to
    higher additional reviewers, reduce the ratio of reviewers to
    managers, and continue the FDA's third-party review program.
        CDRH engaged with the patient advocacy community to best
    characterize disease severity and unmet need. And this led to
    the benefit/risk guidance that we heard a lot about this
    morning that broadly defines the benefits CDRH is interested in
    understanding and started the process for incorporating these
    views into product reviews.
        Recognizing that there were many process improvements
    instituted through MDUFA III, we sought further support for
    CDRH's workforce, expansion of the patient-centered device
    development, and the utilization of real-world evidence in
    MDUFA IV.
        MDUFA IV contains critical commitments and funding for the
    FDA that will benefit patients. We are pleased that the
    reauthorization of the User Fee Agreements is a priority for
    this committee.
        MDUFA IV will lead to significant reductions in the time it
    takes the FDA to review the most common types of medical device
    applications, and that is not only going to benefit industry;
    it is going to accelerate patient access.
        Having expert FDA staff to carry out user-fee-funded
    activities is paramount, and the MDUFA IV agreement permits
    CDRH to apply user fees to increase the retention of high-
    performing supervisors, reduce the ratio of review staff to
    supervisors, and hire new medical device application reviewers,
    as well as to recruit additional HR support services, which is
    something that we were all encouraged by in 21st Century Cures.
        The MDUFA IV agreement seeks to bolster and ensure the
    integrity of the third-party review program, and we are glad
    that CDRH continues to have the resources and flexibility to
    employ outside experts as needed under MDUFA IV.
        CDRH will further advance patient involvement in the
    regulatory process. They will expand staff capacity to respond
    to device submissions containing validated patient preference
    information and patient-reported outcomes.
        CDRH will hold public meetings to discuss approaches for
    incorporating this type of information into device submissions,
    as well as other methods for advancing patient engagement.
        CDRH will explore ways to use patient input to inform
    clinical study design and reduce barriers to patient
    participation in clinical trials.
        MDUFA IV will elevate CDRH's ability to further real-world
    evidence generation for the purposes of informing regulatory
    activities.
        The collection of data generated through routine clinical
    care can help broaden our understanding of how products are
    working, support the incremental process of medical product
    development, and optimize care.
        CDRH can utilize MDUFA IV fees to hire staff with expertise
    in the utilization of real-world evidence and further establish
    the Coordinating Center for the National Evaluation System for
    health Technology. NEST will link health claims, electronic
    records, and registry data.
        MDUFA IV funds, the NEST Coordinating Committee, they are
    going to be able to establish a patient-incorporated pilot
    program to explore the usability of real-world evidence for
    determining expanded access as well as new device approvals,
    and better understand how devices are malfunctioning.
        The NEST public program is particularly meaningful for our
    organization since older adults are not adequately represented
    in clinical studies. The MDUFA IV agreement actually specifies
    that industry will have 25-percent representation on the NEST
    Governing Board, and we hope that the enacting legislation will
    further specify the remaining 75 percent of the Governing Board
    composition and give particular attention to patient
    populations most likely to be affected by increased utilization
    of real-world evidence.
        The MDUFA IV agreements will increase efficiency of the
    regulatory process, reduce the time it takes to bring safe and
    effective medical devices to market, and put patients at the
    heart of medical product developments.
        So, I am going to close by offering our support for the
    continuation of the MDUFA program.
        Thank you for the opportunity to present our views today.
        [The prepared statement of Ms. Bens follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Burgess. And we thank you for your testimony.
        Mr. Kieval, you are recognized for 5 minutes. Summarize
    your opening statement, please.

                       STATEMENT OF ROBERT KIEVAL

        Mr. Kieval. Thank you, Mr. Chairman Burgess, Ranking Member
    Green, and members of the subcommittee, for this opportunity to
    testify today.
        My name is Robert Kieval, and I am the founder of CVRx, a
    small company that provides implantable medical technologies to
    treat patients suffering from heart failure and problematic
    high blood pressure. These are among the most prevalent
    debilitating and expensive diseases for our healthcare system
    to manage, and our therapy which is available today in Europe--
    and, hopefully, will be soon here in the U.S.--stands both to
    improve patients' lives and significantly reduce the staggering
    costs associated with their care.
        I have also been asked to testify here today on behalf of
    the Medical Device Manufacturers Association, founded in 1992
    to be a voice of the innovative and entrepreneurial sector of
    our industry. CVRx is also a proud member of AdvaMed, whom my
    colleague Mr. Daly is testifying for today.
        Ninety-eight percent of medtech companies have fewer than
    500 employees, while more than 80 percent have less than 50.
    Yet, we are the major source of innovation and America's
    competitive advantage in medical technology. Together, we
    comprise a diverse group of engineers, physicians, and
    entrepreneurs who dedicate our lives to alleviating human
    suffering and improving patient care.
        My personal journey with CVRx is now in its 16th year. As a
    small company with one product and no other revenue streams,
    CVRx, like many others in our position, is dependent on outside
    investment to be able to continue our work. To garner
    financing, our investors need assurance that the regulatory
    process be reasonable and consistent. Our capital is limited
    and precious, and regulatory delays can have devastating
    consequences for our company and for the patients who we are
    working to serve.
        Over the past 5 years under MDUFA III, the FDA Safety and
    Innovation Act, and FDA's commitment to those reforms, the
    regulatory process has become more reasonable, consistent, and
    transparent. With the additional resources provided in MDUFA IV
    and, if implemented correctly, we believe that this proposed
    agreement can help further improve access for American citizens
    to safe and effective new medical technologies.
        While speed is always important when lives hang in the
    balance, our membership overwhelmingly endorsed prioritizing
    quality, predictability, and transparency in our negotiations.
    MDUFA IV includes important updates and new elements to
    strengthen and balance the regulatory environment. Here are a
    few highlights:
        There are new provisions to include consideration of
    patient's perspectives in the design of clinical trials, which
    will help tie product evaluation to outcomes that are important
    to patients.
        A pilot to establish the value of real-world evidence and
    linkages among data sources to enable greater use of this
    information, to accelerate patient access in a pre-market
    setting.
        To help keep the review process focused, reviewers would
    now be asked to cite the specific justification and applicable
    regulation for any deficiency letter or data requests that they
    issue. This will ensure that queries are meaningful and that
    time spent by both parties to resolve them is productive.
        A new quality management program will help FDA remain
    efficient as it continues to grow and evolve. The quality team
    will monitor and report on performance across the various
    branches of the agency and help ensure that deficiencies and
    inefficiencies are identified and addressed. This will provide
    more transparency within the FDA and help ensure that our new
    heart failure therapy receives the same quality of review in
    the Cardiovascular Division that a new incontinence treatment
    would in the Urology Division.
        Finally, the agreement establishes new performance goals
    aimed at placing new technologies into the hands of patients
    and providers within a reasonable period of time. These include
    updated decision time targets for 510(k)s and PMAs and now also
    review time goals for de novo technologies and pre-submissions.
        We believe that MDUFA IV can strengthen and provide
    increased confidence in the regulatory process. We also
    acknowledge that it is incumbent upon our industry to ensure
    that our work and our submissions are also of the highest
    quality.
        We thank FDA for these productive negotiations, and we look
    forward to continuing to work with them and with you to
    maintain a regulatory environment that rewards innovation while
    ensuring patient care.
        Surely our healthcare system will continue to face pressing
    challenges in the 21st century. Patients and providers will
    continue to seek therapies that alleviate suffering and save
    lives. My colleagues and I remain committed to finding the
    solutions they need and to working with our fellow stakeholders
    in the healthcare ecosystem to deliver these as quickly and
    efficiently as possible.
        Thank you very much.
        [The prepared statement of Mr. Kieval follows:]

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        Mr. Burgess. The Chair thanks the gentleman for his
    testimony.
        Mr. Daly, you are recognized for 5 minutes to summarize
    your opening statement, please.

                       STATEMENT OF PATRICK DALY

        Mr. Daly. Thank you, Chairman Burgess and Ranking Member
    Green and members of the committee, for the opportunity to
    testify today.
        My name is Patrick Daly, and I am the president and CEO of
    Cohera Medical. Cohera Medical is a rapidly growing, North-
    Carolina-based medical device company with 36 full-time
    employees and over 18 contract employees. Cohera Medical
    develops surgical adhesives and sealants, including the first
    synthetic adhesive approved for internal use.
        I am pleased to testify today on the Medical Device User
    Fee Agreement on behalf of AdvaMed. Collectively, the medical
    device industry is committed to ensuring patient access to
    lifesaving and life-enhancing devices and other advanced
    medical technologies. I am very optimistic about what this
    industry can do for patients if the right policies are in
    place.
        I have been encouraged by the progress at FDA's Device
    Center in recent years, but the innovation ecosystem that
    supports our industry remains stressed. One key barometer of
    the health of our ecosystem is the level of investment in
    startup companies. Unfortunately, we have seen a sharp decline
    in the number of new medical device technology startup
    companies each year and decreased venture capital investment.
    The time horizon for getting a new innovation from the bench to
    the bedside remains far too long. And as a result, investors
    are looking elsewhere.
        Despite these concerning statistics, we believe we are on
    the right track at FDA's Device Center and that recent
    progress, combined with the provisions of this new User Fee
    Agreement, promise to keep things headed in the right direction
    and strengthen the medtech innovation ecosystem.
        Of course, there are many areas where FDA could further
    enhance the predictability and efficacy of its review process,
    and the new MDUFA IV agreement lays out the groundwork for
    further FDA performance improvements through five key areas:
    more ambitious goals, greater patient involvement, important
    process changes, and increased accountability, all supported by
    additional resources. And I would like to quickly describe
    these five key areas.
        First, MDUFA IV goals for total time reviewing product
    represent substantial improvements over current performances.
    Measuring the total time from submission to FDA decision to
    either make the technology available to the patients or deny
    approval is the most meaningful measure of progress.
        For 510(k) products, the total time goal of MDUFA IV
    decreased by 13 percent, which returns the total time to
    historical norms. For PMA products, which are the most
    innovative and high-risk products, the total time to decision
    goal was lowered by 25 percent.
        Second, as we all know, patients have a critical voice in
    product development and evaluation. This MDUFA IV agreement
    will have increased resources dedicated to supporting patient
    involvement in the medical device regulatory process.
        Third, the agreement includes process improvements that we
    anticipate will enhance the consistency and timeliness of the
    review process independent of the specific time goals. One
    example of a process improvement, that the agreement provides
    for meaningful pre-submission interaction between FDA and
    companies. Interactions between the sponsor of the medical
    device application and the FDA prior to formal submission of a
    product application can provide helpful guidance that aids the
    sponsor in ensuring their application contains all necessary
    information. This pre-submission process was first put into
    place 5 years ago in MDUFA III and has benefitted both industry
    and FDA. This MDUFA IV agreement builds upon this success by
    adding in specific time commitments tied to pre-submission
    meetings.
        Fourth, the agreement provides for greater accountability.
    Greater accountability means that FDA's success under the
    agreement will be transparent to FDA management, to industry,
    to patients, and to Congress and the administration, so that
    any problems that arise can be corrected promptly. New
    reporting tools and two independent management reports will
    provide key data to track FDA performance, highlight any
    failures to meet key goals, and provide the basis for
    corrective actions.
        Lastly, to give FDA additional tools to meet these goals,
    the agreement provides additional funds for FDA. These
    resources will give FDA what it needs to continue to improve
    performance. Each of the provisions of this agreement has the
    potential to make a difference in continuing to improve FDA
    performance, but the whole is truly greater than some of its
    parts. Each of the elements of the agreement reinforces the
    other. And, of course, no agreement, no matter how good on
    paper, is self-executing. Making it work as intended will
    require the full efforts of FDA's dedicated staff and managers.
    Our industry is committed to work with FDA in any way we can to
    make it a success. Continued oversight and interest from
    Congress will also be important. Patients are depending on us.
        Finally, I should note that we are appreciative of the
    efforts by all Members who seek to give the FDA the tools and
    structure it needs to succeed. Legislative reforms that do not
    alter the substance of the negotiated agreement between FDA and
    industry hold the potential to create a legislative
    reauthorization package that maximizes the opportunity for
    success at the agency.
        I appreciate the committee's work in considering these and
    other important measures that enhance and complement the
    underlying User Fee Agreement.
        I want to thank the committee for their time today.
        [The prepared statement of Mr. Daly follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Burgess. Thank you, Mr. Daly, for your testimony.
        And now, I recognize Ms. Wurzburger for 5 minutes to
    summarize her written testimony.

                     STATEMENT OF DIANE WURZBURGER

        Ms. Wurzburger. Chairman Burgess, Ranking Member Green, and
    distinguished members of the subcommittee, thank you for the
    opportunity to appear before you today to discuss the FDA's
    Medical Device User Fee Program.
        I am Diane Wurzburger, executive, Regulatory Affairs for GE
    Healthcare. I am here today to testify in support of the MDUFA
    IV agreement and on behalf of the Medical Imaging and
    Technology Alliance. I served as a MITA industry representative
    to the MDUFA IV negotiations with FDA.
        MITA is the collective voice of medical imaging equipment
    and radiopharmaceutical manufacturers, innovators, and product
    developers. These technologies include MRI, x ray, CT,
    ultrasound, nuclear imaging, radiopharmaceuticals, and imaging
    information systems.
        Advancements in medical imaging are transforming health
    care through earlier disease detection, less invasive
    procedures, and more effective treatments. The industry is
    extremely important to American health care and noted for its
    continual drive for innovation, fast-as-possible product
    introduction cycles, complex technologies, and multifaceted
    supply chains. Individually and collectively, these attributes
    result in unique concerns as the industry strives towards the
    goal of providing patients with the safest, most advanced
    medical imaging currently available.
        MITA continues our strong support for an effective, well-
    resourced FDA capable of fulfilling its mission to protect and
    promote the public health. The medical imaging industry
    supported enactment of FDA's User Fee Program in 2002 and its
    subsequent reauthorizations in 2007 and 2012. We participated
    in the MDUFA IV negotiations and believe that this agreement,
    if enacted, will improve FDA review of medical devices,
    assuring that American patients have timely access to safe and
    effective medical devices.
        User fees provide for a more efficient pre-market clearance
    process, allowing for lifesaving devices to get to market more
    quickly. We believe that enhanced FDA funding provides
    stability and predictability to the device review process and
    to timeliness. Without a consistent and timely FDA review
    process conducted by a well-trained staff, access to new
    diagnostic imaging equipment is delayed and industry's ability
    to deliver technological advancements is compromised.
        With this in mind, the medical imaging community has been
    consistent in its desire for more predictability, consistency,
    transparency, and timeliness throughout the device pre-market
    review process. MITA and its members believe that all MDUFA
    commitments should be backed by appropriate, measurable, and
    predictable performance goals that support these principles.
        We are particularly pleased to see performance metrics for
    reduction in total time to review for 510(k)s to 108 days. The
    MDUFA IV agreement will make key improvements to the device
    review program, providing the agency with resources necessary
    to expedite the pre-market process while maintaining FDA's
    standards for safety and effectiveness.
        Similarly, we support the metrics for the pre-submission
    program. A pre-submission provides the opportunity for a
    manufacturer to obtain feedback prior to the submission of a
    device application. This program has brought value to industry
    and will continue to do so in a more predictable, consistent,
    and timely way with specific measurable metrics under the MDUFA
    IV agreement.
        MITA fully supports the center-wide Quality Management
    Program. We believe that an effective quality management
    framework will support more consistent and predictable device
    review. The FDA will identify an annual audit plan and conduct
    those audits with an eye for sharing high-performing pre-market
    review processes between divisions in the agency. MITA believes
    that identifying good practices throughout the agency and
    sharing them will lead to improved efficiency and
    effectiveness.
        Included in the MDUFA IV agreement is the establishment of
    an accreditation scheme for conformity assessment program. This
    program allows for devices to be evaluated according to
    specific recognized standards by certified testing
    laboratories. FDA has agreed not to review full test reports
    from these laboratories except as part of a periodic audit.
    MITA is a strong proponent of the use of voluntary consensus
    standards and believes that the ASCA program will reduce time
    to decision and provide more predictability to the process.
        Finally, MITA believes that a third-party independent
    assessment is critical to determine whether the investment in
    the pre-market review program is providing a more consistent,
    predictable, and timely decision by the FDA. We look forward to
    participating in the comprehensive assessment of this process
    for the review of device applications and think it is important
    to not only complete the evaluation that was started under
    MDUFA III, but to also begin evaluating the programs funded by
    MDUFA IV.
        We believe that the MDUFA IV agreement will lead to an
    improvement in patient access to safe and effective medical
    devices. Most importantly, we are committed to ensuring the
    ultimate beneficiaries of these negotiations, the American
    public, benefit from continued improvements and timely access
    to the innovative devices and diagnostics necessary for the
    public health. MITA urges Congress to move quickly to
    reauthorize MDUFA IV.
        Thank you for the opportunity to present our views today. I
    am happy to answer any questions you have.
        [The prepared statement of Ms. Wurzburger follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Burgess. The gentlelady yields back, and the Chair
    thanks all of our witnesses for their testimony today.
        And the Chair would note that Dr. Shuren has remained in
    the audience, and I certainly thank him for that.
        As we move into the question-and-answer portion for our
    second panel, I want to recognize Dr. Bucshon of Indiana. Five
    minutes for questions.
        Mr. Bucshon. Thank you, Mr. Chairman.
        Mr. Daly, I know that the medical device industry is
    dominated by small companies. Indiana has over 300 medical
    device companies, including small companies all the way to some
    of the big-name companies that all of us know.
        So, my question is, I understand the MDUFA agreement has
    some provisions in there that are directed toward smaller
    companies. Can you explain these provisions that are helpful to
    smaller companies?
        Mr. Daly. Thank you very much.
        I think the overall climate at FDA is helpful for small
    companies. Obviously, we do not have the staff that a larger
    company would. So, one example is what Dr. Shuren mentioned
    this morning, the pre-IDE meetings, having those communications
    prior to the meetings. Right now, we get those now five days in
    advance. It allows us to prepare. More importantly, it allows
    FDA to ask questions in a timely manner. I will give you an
    example.
        Prior to this, when we were still in a slower stage, we had
    a personal example of we flew my team down here for a meeting
    that we got the questions the night before. I don't think it
    was as effective a meeting.
        And I do want to compliment Dr. Shuren, Dr. Maisel, and his
    entire staff, for really putting a lot of effort into this over
    the last 4 or 5 years to make that a better process.
        Mr. Bucshon. Thank you.
        And just a general question of interest to me, to anyone. I
    will start with you, Ms. Wurzburger. A more, what I would call,
    streamlined and effective review process that cuts down on the
    time to get a product to the marketplace, what would you
    estimate is the potential savings to overall medical costs and
    to your ability to get products to the market? Because if you
    stretch out a process and it takes you longer, it costs you
    more money. I mean, do you have any thoughts, just general
    thoughts, on that and the importance of a process that works as
    expediently as possible?
        Ms. Wurzburger. I believe an efficient process, a more
    predictable process allows a manufacturer to plan internally
    for their own quality system processes and those other testing
    requirements that are needed to prepare that submission
    effectively.
        I would say that, just generally, with diagnostic imaging
    and the technologies, as we are able to bring those to the
    market more efficiently and more timely, that there is an
    impact on the overall healthcare costs, I believe, on the
    system, as we are able to have innovations that will better
    diagnose patients and perhaps impact a patient's treatment plan
    more rapidly.
        Mr. Bucshon. Yes, I think I will just comment on it. I was
    a cardiovascular and thoracic surgeon before I was in Congress.
    You can't underestimate the long-term savings of getting really
    innovative products to patients earlier, and some people have
    mentioned that. If it improves people's quality of life and
    keeps them out of the hospital and keeps them from getting
    constantly more expensive medical care over a prolonged period
    of time, which could be decades even, that is something that I
    think is extremely important.
        Does anyone else have any comments on the--yes, Mr. Kieval?
        Mr. Kieval. Thank you.
        Yes, first off, with the diseases that we treat,
    particularly heart failure, you know, survival is a big
    problem. I mean, annual mortality rates and heart failure can
    be over 10 percent. Five-year mortality is over 50 percent. So,
    really, time is life with our therapies.
        And to your point, our therapies are intended to return
    patients to full life, keep them out of the hospital, which is
    a major source of financial burden to the healthcare system.
        Even as a small company with the most efficient operations
    that we can muster, our monthly burden rate exceeds a million
    dollars a month. So, every month of delay due to--whether it is
    for good reason or not for good reason--is another million-
    dollar turn of the crank for our company. That is money that is
    taken away from innovation and further efficiency in the
    system. So, I think that streamlining the system can have lots
    of benefits, from saving lives, improving lives, reducing
    costs, and fostering innovation.
        Mr. Bucshon. I think it was you that mentioned the ability
    to attract venture capital investment in startup companies or
    smaller companies is impacted by this also, by this process,
    right?
        Mr. Kieval. Absolutely. I think, as we look, two big
    hurdles for companies in our position have both been talked
    about, regulatory approval and, then, reimbursement. And
    reimbursement is not the focus of this panel.
        But the more that we can do to provide a sense of assurance
    and confidence to prospective investors in the function of
    these processes, not necessarily in the outcome, but in the
    efficient function of these processes, the more they are going
    to be interested in returning to participate.
        Mr. Bucshon. I yield back, Mr. Chairman.
        Mr. Burgess. The gentleman yields back. The Chair thanks
    the gentleman.
        The Chair recognizes the gentleman from Houston, Texas, Mr.
    Green, the ranking member of the subcommittee.
        Mr. Green. Only because he is from Denton, Texas. So, we
    don't have to have an interpreter----
        [Laughter.]
        Mr. Burgess. Recognized for 5 minutes for questions.
        Thank you.
        Mr. Green. Thank you, Mr. Chairman.
        Our committee and I worked on breakthrough pathway for
    device precision. It was in the 21st Century Cures. I am
    delighted the provision is now in law.
        Mr. Daly, in my understanding, your company received
    Expedited Access Pathway, or EAP, designation for one of your
    products which was a precursor to the breakthrough designation.
    Can you explain what the EAP program is and what it means for
    your company?
        Mr. Daly. Congressman Green, thank you for the question.
        As a sidebar, I was a sales representative for Dr. DeBakey
    down in Houston 25 years ago. So, you brought back some
    memories.
        Mr. Green. I have a picture that is probably 25 years old.
        [Laughter.]
        Mr. Daly. So, the Expedited Access Pathway, you know,
    basically, for us, as our company, our product is called Sylys.
    It is a second PMA product, a pre-market-approved product that
    we have. What it does is it is a sealant that goes around a
    stable or suture line for colorectal surgery or gastric bypass
    surgery. What this does is it reduces leaks by 70 percent.
        What this has been able to do through the EAP program is
    take about a year and a half off the process for us to get into
    a pilot study. As was mentioned here, at a million dollars a
    month, that is a significant savings.
        We are really excited that we were the first product
    approved through EAP program, and we are working through that.
    What it has done, too, for us, as an investor or as a company,
    is we have brought in some pretty significant investment. Over
    $50 million came because of our EAP designation. So, it has
    been a very big windfall for us.
        Mr. Green. It is not often that Members of Congress hear
    something that goes right. Normally, we hear that it goes
    wrong. And thank you and I am excited about the potential not
    only for you, but the breakthrough pathway for medical devices
    and these agreements here.
        Mr. Kieval, you mentioned in your testimony that agreement
    includes new performance goals aimed at getting new
    technologies to patients by including updated decision time
    targets for 510(k)s and PMAs and review time goals for de novo
    technologies and pre-submissions. Can you elaborate on these
    enhanced performance goals and how you feel they would benefit
    industry and the patients?
        Mr. Kieval. Yes, thank you for that question. By the way,
    we are also participating in the Expedited Access Pathway
    Program.
        Mr. Green. Great.
        Mr. Kieval. And I would echo Mr. Daly's comments on that.
        So, from my perspective, I think speed is a great byproduct
    of an improved regulatory process, but I am not sure that, you
    know, I interpret the new performance goals under MDUFA IV as
    speed for speed's sake. I think there are important
    improvements to the process, important efficiencies to be
    gained, and that we can expect, as a result, greater speed
    because there is less wasted time, less unnecessary questions
    in going back and forth between innovators and the FDA.
        So, the goals are meaningful because, once again, it is
    going to enhance access to patients whose lives hang in the
    balance, at least with the diseases that we are treating. It is
    going to make sure that resources are used most efficiently for
    innovation purposes. It is going to provide predictability for
    the investment community. So, I think it is going to have,
    these new goals are going to have myriad forms of benefits,
    but, again, as a byproduct of an improved process, not as a
    means to an end in and of themselves.
        Mr. Green. Thank you.
        Ms. Wurzburger, do you have anything to add to that
    question?
        Ms. Wurzburger. No, I would just echo that I think that,
    although we are a larger organization than some of the small
    companies represented by my colleagues here, for us as well an
    efficient process allows us to reinvest in our innovations, in
    our R&D, resources that we need internally to ensure our
    products are safe and effective coming out the door.
        Mr. Green. Ms. Bens, the Alliance for Aging Research has
    been a leading advocate for the inclusion of patient views on
    the benefits and risks of devices during the product reviews.
    Can you talk about how this agreement builds on MDUFA III to
    expand patient-centered medical device development?
        Ms. Bens. Absolutely. Thank you very much for the question.
        The one thing that I point to that was most beneficial to
    organizations like ours was the ability to interact with CDRH
    right from the start in defining what the unmet needs were for
    patients as well as what their most important benefits were
    that they were going to potentially see from medical products.
        And I would give Dr. Shuren and the rest of the staff at
    CDRH a lot of credit for how comprehensive that risk/benefit
    guidance really was and setting the stage for a framework where
    not only developers can really be pointing to the criteria that
    CDRH was going to use for evaluating benefit/risk, but also
    groups like ours could play more of a proactive role in
    identifying different types of research that could better fill
    those gaps and lead to endpoints that were going to be more
    meaningful to patients.
        And I would say the next step that CDRH really took was the
    establishment of their Patient Engagement Advisory Council.
    That is something that we are really excited about, and we know
    that they are already in the process of planning their first
    meeting. But this will take the additional step of really
    implementing that guidance in a way that is going to be
    transformative.
        I know there was a little bit of talk earlier about the
    issue of guidance and the FDA's ability to issue guidance. And
    this is one area where the PEAC is going to be a bit different
    from other types of patient engagement activities at the FDA.
    There is really going to be the opportunity for patients and
    their representatives to have a seat at the table in helping to
    provide guidance to the Commissioner on how they can develop
    guidances that are truly going to be patient-centered and lead
    to better studies. So, we are really excited about that. And
    the MDUFA fee funds really going hand-in-hand with funding
    those types of activities.
        Mr. Green. Thank you, Mr. Chairman, and I thank our
    witnesses for being here.
        Mr. Burgess. The gentleman yields back.
        The Chair recognizes himself for 5 minutes for purposes of
    questions. And let me ask a question of our three industry
    representatives, because this is apropos of you and, then, Ms.
    Bens, I am going to include you in something in just a moment.
        But, of course, we are talking about the FDA, what the FDA/
    CDRH can do to make its path more straightforward. But, as an
    industry, what are you all doing to make certain that your
    submissions are of the highest quality to lessen the likelihood
    of having to come back and retrace steps?
        Now, Ms. Wurzburger, let me start with you and, then, we
    will just go down the line.
        Ms. Wurzburger. Sure. Thank you for the question.
        Yes, I think, as we have heard through some of the
    testimony, a lot of the processes that are funded through this
    new User Fee Program, such as the pre-submission process, is
    very, very useful for us as manufacturers. That interactive
    dialog with the agency and discussion around the endpoints they
    expect and the data that they are looking for in those
    submissions allows us to go back into our internal processes
    and ensure that the submissions we are putting together are
    robust and contain that information on the first round. We are
    constantly improving that, as we acquire additional feedback
    from the agency and from other sources. So, it is very helpful
    for us.
        Mr. Burgess. Mr. Daly?
        Mr. Daly. Mr. Chairman, I think what you see collectively
    up here are companies that are part of trade organizations and
    organizations that really do, in my view, an excellent job,
    whether it is MITA or MDMA or AdvaMed, of taking the side that
    industry needs to also do a good job in presenting their either
    510(k) or PMA.
        And so, if you look across all three of these particular
    agencies, they do a very good job of training new companies,
    providing companies access to the bigger company information.
    As an example, I am chairman of, within AdvaMed, Excel, which
    is a part of AdvaMed that is companies that have less than $100
    million in revenue. It makes up about 80 percent of our
    membership for all of AdvaMed. So, they do a really good job of
    helping companies navigate and get the right information.
        Mr. Burgess. Thank you.
        Mr. Kieval?
        Mr. Kieval. Yes, I think my colleagues really summarized
    those very well. We are a small company. We are a single-
    product company. This is all we have got. If we run out of
    money before we get it across the goal line----
        Mr. Burgess. Can I ask you about that?
        Mr. Kieval. Sure.
        Mr. Burgess. Because, I mean, I was struck in your written
    testimony and your testimony here. I mean, you are right, you
    are a small company. You have got one thing. You have got one
    job, as they say. And so, if we make your life hard, harder,
    impossible, I mean, it has a profound effect, then, not just on
    you and your employees, but, of course, patients who depend on
    the products.
        And it sounds like--we haven't really gotten into what the
    products are that your particular company is dealing with--but,
    I mean, in your testimony you said that the sweetest
    grandmother waiting for the device and someone else who was
    waiting for it. And these are outside the country. And so, our
    patients inside the country are still waiting for those
    devices, is that correct?
        Mr. Kieval. So, in our own experience, our products have
    been on the market for a few years outside the United States,
    in Europe. We are excited about being able to treat patients
    there. We are very eager to have our products approved here in
    the United States.
        We are very fortunate to be, as part of the Expedited
    Access Pathway program, and we are in the middle of what we
    hope is our definitive clinical trial to bring our product to
    the U.S. market. So, we have continued throughout our 16-year
    history--it has always been a goal to bring our product here to
    the United States. I think it has been a difficult process. It
    has been a worthwhile process. We have welcomed the
    enhancements under MDUFA III. We are looking forward to the
    enhancements under MDUFA IV and working with the FDA to
    complete that development process to bring this innovation to
    U.S. patients.
        Mr. Burgess. Well, I think I have heard it said more than
    once today on the panel in front of us the words ``alleviate
    suffering''. And, Ms. Wurzburger, I think in your testimony you
    talked about things that were at one time science fiction are
    now the standard of care.
        And when I talk to groups of medical students, residents,
    people sometimes despair of what they see on the policy side up
    here and we never agree on anything and we are fighting about
    everything. But, honestly, the next generation of doctors is
    going to have tools at their disposal that no generation of
    physicians has ever known, thanks to the work of the agency and
    thanks to the work of the innovators and the advocacy groups,
    the things that all of you put your heart and soul into.
        So, for that, I want to thank you. I want to thank you for
    being here today.
        I was going to recognize Mr. Carter, but he is exiting. He
    is exiting stage right, and he will submit for the record.
        Mr. Green is already gone. So, I can't ask him for a
    followup.
        But it has been a fascinating day and a fascinating panel.
    I think you have heard throughout the discussion today how the
    goodwill exists to get this done. And while things may move
    into the headlines that like to highlight where we can't agree
    on a single thing, this is something where we all agree.
        We have heard it said other times during the hearing that,
    yes, we welcome submissions and inputs. If people have better
    ideas, if there is a better way, talk to us. But, make no
    mistake about it, we are getting our work done.
        And again, I think I credit Dr. Shuren for staying here
    through the industry testimony. I think that is indicative of
    how everyone wants this process to not just conclude, but to
    conclude successfully.
        So, seeing that there are no further Members wishing to ask
    questions, I do want to thank our witnesses for being here
    today.
        And pursuant to committee rules, I remind Members they have
    10 business days to submit additional questions for the record.
        I ask witnesses to submit their responses within 10
    business days of the receipt of those questions. And we had no
    unanimous consent requests? No unanimous consent requests.
        Without objection, the subcommittee is adjourned.
        [Whereupon, at 12:45 p.m., the subcommittee was adjourned.]
        [Material submitted for inclusion in the record follows:]

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        [Ms. Bens did not answer submitted questions for the record
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        [Mr. Daly did not answer submitted questions for the record
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