[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:]
    
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    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:]
    
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    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:]
    
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    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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