[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]








  MEDICAL DEVICES: ARE CURRENT REGULATIONS DOING ENOUGH FOR PATIENTS?

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 18, 2009

                               __________

                           Serial No. 111-52










      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov

                                _____

                  U.S. GOVERNMENT PRINTING OFFICE

74-086                    WASHINGTON : 2012
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing 
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC 
area (202) 512-1800 Fax: (202) 512-2104  Mail: Stop IDCC, Washington, DC 
20402-0001








                    COMMITTEE ON ENERGY AND COMMERCE

                 HENRY A. WAXMAN, California, Chairman

JOHN D. DINGELL, Michigan            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois       SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA CHRISTENSEN, Virgin Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE BRALEY, Iowa
PETER WELCH, Vermont

                                  (ii)
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
BART GORDON, Tennessee                   Ranking Member
ANNA G. ESHOO, California            RALPH M. HALL, Texas
ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    HEATHER WILSON, New Mexico
DIANA DeGETTE, Colorado              JOHN B. SHADEGG, Arizona
LOIS CAPPS, California               STEVE BUYER, Indiana
JAN SCHAKOWSKY, Illinois             JOSEPH R. PITTS, Pennsylvania
TAMMY BALDWIN, Wisconsin             MARY BONO MACK, California
MIKE ROSS, Arkansas                  MIKE FERGUSON, New Jersey
ANTHONY D. WEINER, New York          MIKE ROGERS, Michigan
JIM MATHESON, Utah                   SUE WILKINS MYRICK, North Carolina
JANE HARMAN, California              JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas           TIM MURPHY, Pennsylvania
JOHN BARROW, Georgia                 MICHAEL C. BURGESS, Texas
DONNA M. CHRISTENSEN, Virgin 
    Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
  












                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     1
Hon. Nathan Deal, a Representative in Congress from the State of 
  Georgia, opening statement.....................................     3
Hon. Lois Capps, a Representative in Congress from the State of 
  California, opening statement..................................     3
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     3
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................     4
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     6
Hon. Donna M. Christensen, a Representative in Congress from the 
  Virgin Islands, opening statement..............................     7
Hon. Phil Gingrey, a Representative in Congress from the State of 
  Georgia, opening statement.....................................     8
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     9
Hon. John P. Sarbanes, a Representative in Congress from the 
  State of Maryland, opening statement...........................    10
Hon. Kathy Castor, a Representative in Congress from the State of 
  Florida, opening statement.....................................    11
Hon. Bruce L. Braley, a Representative in Congress from the State 
  of Iowa, opening statement.....................................    11
    Prepared statement...........................................    14
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, prepared statement..............................    92

                               Witnesses

Marcia Crosse, Director of Health Care, Government Accountability 
  Office.........................................................    17
    Prepared statement...........................................    20
    Answers to submitted questions...............................    93
William H. Maisel, M.D., Ph.D., Director, Medical Device Safety 
  Institute, Department of Medicine At Beth Israel Deaconess 
  Medical Center.................................................    42
    Prepared statement...........................................    44
Phillip J. Phillips, M.D., MPH., Independent Consultant..........    52
    Prepared statement...........................................    55
    Answers to submitted questions...............................    95
Peter Lurie, M.D., M.P.H., Deputy Director, Health Research 
  Group, Public Citizen..........................................    58
    Prepared statement...........................................    62
    Answers to submitted questions \1\...........................

----------
\1\ Mr. Lurie did not respond to submitted questions for the 
  record.

 
  MEDICAL DEVICES: ARE CURRENT REGULATIONS DOING ENOUGH FOR PATIENTS?

                              ----------                              


                        THURSDAY, JUNE 18, 2009

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:30 a.m., in 
Room 2322 of the Rayburn House Office Building, Hon. Frank 
Pallone Jr. [Chairman of the Subcommittee] presiding.
    Members present: Representatives Pallone, Dingell, Green, 
Capps, Matheson, Barrow, Christensen, Castor, Sarbanes, Murphy, 
Space, Braley, Deal, Buyer, Pitts, Burgess, and Gingrey.
    Staff present: Steve Cha, Professional Staff Member; Sarah 
Despres, Counsel; Elana Leventhal, Policy Advisor; Karen 
Nelson, Staff Director for Health; Alvin Banks, Special 
Assistant; Caren Auchman, Communications Associate; Karen 
Lightfoot, Communications Director; Clay Alspach, Counsel; and 
Chad Grant, Legislative Analyst.

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

    Mr. Pallone. The subcommittee is called to order, and I 
will recognize myself initially for an opening statement. 
Today's subcommittee is meeting to discuss the FDA's regulation 
of and authorities over medical devices. The goal of today's 
hearing is to determine if the current regulations are doing 
enough for patients while ensuring that these very important 
and sometimes life-saving devices are truly safe and effective.
    We are here to hear about where the current system works 
well and where shortfalls might be. There is evidence of an 
approval system that is broken, that its standards, its 
procedures and its rules don't meet modern needs of getting 
medical devices to those in need with confidence in their 
safety.
    We have made huge advances in medicine over the last few 
decades. Many illnesses that were once a death sentence are now 
preventable, curable or at least manageable through modern 
medical treatments. New and emerging technologies hold promises 
that our great-grandparents could never have imagined, and the 
medical device industry is one of the main drivers of this 
progress.
    From pacemakers to artificial hips to tongue depressors, we 
can't enter the health care system without coming into contact 
with these devices. And we need an approval process that keeps 
pace with new technologies, a modern process consistent with 
progress in medicine. We have to maintain the delicate balance 
between wanting to put these new technologies in the hands of 
patients who desperately need them and ensuring that the 
devices are actually safe for use in humans.
    Now, last month this subcommittee held a hearing on the 
issue of preemption in the wake of the Regal versus Metronix 
Supreme Court decision. The Supreme Court ruled that patients 
could not receive compensation for their injuries, medical 
expenses, and lost wages caused by defective, pre-market 
approval or PMA devices or inadequate safety warnings.
    While state product liability provides incentives for 
companies to make safe products, it should not be the only tool 
we have to ensure that the medical devices that are on the 
market today are safe. We need to know that the approval 
process and the regulatory standards are strong and enforceable 
and that the agency is empowered with the ability to ensure the 
safety of these products.
    It is for this reason that we are here today at this 
hearing on the medical device approval process. I want a 
comprehensive overview of the major issues and potential 
problems that may arise in the regulation of medical devices. 
Of greatest importance to me is to find out what the FDA needs 
to ensure that the medical devices on the market are safe and 
effective.
    In the FDA Amendment Act of 2007, I requested a GAO study 
to look specially at the 510(k) process and in particular focus 
on the pre-amendment devices that have never been through the 
FDA approval process.
    The GAO is here today and will talk about that report in 
more detail. And I am interested to hear how the FDA is moving 
to review the high risk class three devices that have yet to 
ever be approved formally, as Congress instructed the FDA to do 
in the Safe Medical Device Act of 1990.
    Why is it taking so long for the FDA to act, and what is 
the consequence of this inaction? Are there devices being 
cleared onto the marketplace that shouldn't be?
    But beyond this particular study, the GAO has written other 
reports on medical devices. These studies have highlighted some 
of the successes and possible failures in FDA's ability to 
properly assess the safety and effectiveness of devices as well 
as maintain sufficient post-market surveillance and controls to 
ensure the devices patients are using continue to work the way 
they are supposed to.
    And I am looking forward to hearing more about these 
findings as well. I also look forward to other witness 
testimony and hope that they give our committee members an in-
depth look into how the process is working and where it may 
need to be fixed either through legislation or through 
increased and enhanced oversight at the FDA. At the end of the 
day, we are all talking about real people here, patients who 
need to know that these devices will do what they say, that 
they are supposed to do, and they won't cause them avoidable 
harm.
    I want to thank particularly Dr. Marcia Crosse from the GAO 
and her team's tireless efforts to ensure that we are 
responding to the needs of patients. And now I would recognize 
Mr. Deal, our ranking member, for an opening statement.

  OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Deal. Thank you, Chairman Pallone. Thanks to our 
witnesses for being here today. Since we have several of you, I 
will not take too much time in my opening statement but simply 
to reiterate that all of us, I think, share a concern that in 
this area of medical devices that they be safe and that they do 
what they are supposed to do and that the approval process is 
adequate and that the approval process is not unduly delayed. 
So there is a delicate balance that has to be reached in terms 
of the approvals.
    I am especially concerned in light of what this committee 
has placed on the FDA in recent weeks from tobacco regulation 
to yesterday an enhanced food safety bill. All of us understand 
the importance of all of these areas and support it. But I 
think one of the critical questions that always has to be asked 
is are we giving the FDA the resources and the abilities, 
legislatively or otherwise, to do what we are asking them to 
do.
    Each of you share an insight into those questions, and I 
look forward to your testimony and I yield back my time. Thank 
you.
    Mr. Pallone. Thank you, Mr. Deal. Next is our subcommittee 
vice chair, Ms. Capps, from California.

   OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Ms. Capps. Thank you, Chairman Pallone, and we have great 
witnesses here so I will be brief as well. But I am very 
pleased and I want to note that we are holding this very 
important hearing today.
    I believe that members of Congress do have a duly to 
evaluate and reevaluate regulations to make sure that we are 
doing all we can to get safe and effective medical devices to 
American patients. However, safety and effectiveness are not 
the only things we need to keep in mind as we consider these 
regulations.
    We must also ask do the rules in place pose any barriers to 
technological innovation, barriers that might hamper the 
improvement of prevention, diagnosis, and treatment of disease. 
Ultimately our evaluation must include assessing the pre-market 
and post-market processes for safety and effectiveness as well.
    And I am glad that our committee takes seriously our role 
in the oversight on that process. I am eager to hear 
recommendations from our witnesses on what works, what doesn't, 
and how we can adequately address both. I yield back.
    Mr. Pallone. Thank you. The gentleman from Indiana, Mr. 
Buyer.
    Mr. Buyer. I reserve my time.
    Mr. Pallone. Gentleman from Georgia, Mr. Barrow.
    Mr. Barrow. I waive.
    Mr. Pallone. Gentleman from Pennsylvania, Mr. Pitts.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Pitts. Thank you, Mr. Chairman. Thank you for convening 
this hearing. More than 8,000 new medical devices come to 
market in the U.S. each year ranging for syringes and surgical 
gloves to pacemakers and heart valves.
    The medical device amendments of 1976 gave FDA the 
responsibility of ensuring that medical devices are safe and 
effective and provided a risk-based framework for FDA to 
evaluate the wide variety of devices seeking approval.
    The majority of class two or moderate risk medical devices 
come to market through pre-market notification, also known as 
the 510(k) process. 510(k) submission must demonstrate that the 
new device is substantially equivalent to one or more similar 
devices legally marketed in the U.S. And this excludes pre-1976 
grandfathered medical devices.
    And the new device cannot be found substantially equivalent 
to a device that has been deemed misbranded or adulterated or 
removed from the market. To be substantially equivalent, the 
product must be at least as safe and effective as the legally 
marketed or predicate device, must have the same intended use 
and technological characteristics as the predicate, or if the 
intended use is the same but the technological characteristics 
differ, the technical differences must be shown to raise no new 
questions of safety and effectiveness.
    510(k) submissions must include descriptive data or 
specifications, performance testing, and in approximately 10 
percent of cases, clinical data. The 510(k) process has evolved 
over the last 30 years and has served the American public well. 
It provided FDA the discretion and flexibility to apply the 
proper amount of oversight to each device submission. It 
provides for timely product review, and it encourages 
technological innovation and evolution of device technology.
    GAO released a report in January of this year. It said 
``shortcomings in FDA's pre-market review, post-market 
surveillance, and inspections of device manufacturing 
establishments'' and I anticipate that Ms. Crosse will have 
more to say on the matter. But I believe the criticisms 
outlined in the report have more to do with FDA's actions and 
inactions its lack of resources than the statutory approval 
process for medical devices itself.
    I look forward to hearing from the witnesses, and thank 
you. And yield back my time.
    Mr. Pallone. Thank you, Mr. Pitts. Chairman Dingell.

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Dingell. Mr. Chairman, good morning. Thank you for 
holding this hearing on the current state of medical device 
regulation. I want to thank today's witnesses and look forward 
to their informative testimony. I also want to thank you for 
yesterday's work and my colleagues on the committee for what we 
did with regard to Food and Drug in the area of foods. This is 
a worthy successor for that undertaking, and I am delighted to 
see the way that you are leading on this matter. It is very 
important that we address the concerns that are developing with 
regard to the balance of the responsibilities at Food and Drug 
on pharmaceuticals, cosmetics, and devices.
    In response to the question that you propose in the title 
of this hearing, I am convinced that more could be done to 
protect patients. This year alone, there have been nine class 
one recalls of medical devices. It is to be noted that these 
recalls are occurring in a very badly staffed, indeed 
understaffed, agency without the resources to properly monitor 
its responsibilities.
    Class one recalls, as we know, are the most serious type of 
recall. It involves situations in which there is a reasonable 
probability that use of these products will cause serious 
injury or death.
    I would note that the device industry is a responsible 
institution and is composed of responsible people. And I know 
they will want to work with us to make progress in terms of 
assuring safety of the American consumers and the competition 
in that particular portion of the medical services industry and 
is conducted in a way which does not constitute a race to the 
bottom.
    Examining the regulatory framework that we currently 
confront for medical device approval, a few questions come to 
mind. First, is the current medical device approval standard 
``reasonable assurance of safety and effectiveness'' rigorous 
enough? Second, does FDA rely on quality clinical studies 
during the medical device approval process? Third, is the 
current 510(k) review able to adequate ensure that devices that 
are marketed through this abbreviated approval process are safe 
and are being handled in a way consistent with the public 
interest? Last, is there too much discretion allowed to FDA in 
determining whether, through the 510(k) process, new device has 
the ``safe intended use'' or whether it has different 
technological characteristics?
    This is a matter of no small importance. FDA premarkets 
notification process for medical devices has been in place 
since 1976. Low-risk and moderate-risk devices are subject to 
abbreviated 510(k) process. With some exceptions, high-risk 
devices require premarket approval, PMA, process. Devices that 
were on the market prior to the Medical Device Amendments, MDA, 
were allowed to remain on the market with the assumption that 
FDA would later determine the product's safety. We need to know 
whether this has been done, and I don't think anybody can 
answer that question at this particular time.
    Unfortunately, it appears that many of these products did 
not undergo rigorous review mechanisms, and unfortunately, we 
have other devices coming on the market using pre-MDA devices 
as a reference device. That is something that imposes 
substantial risk and peril on American consumers.
    I also have concerns with the frequency of inspection of 
medical device establishments, and this is something we ought 
to listen to carefully. GAO estimated that FDA inspects foreign 
manufacturers of modest-risk devices only once every 27 years. 
And foreign high-risk manufacturers every six years despite the 
fact that there are more registered device manufacturers in 
China than any other foreign countries.
    Chinese firms--listen to this--can expect FDA to visit them 
only once every 50 years. I don't think anyone in this room can 
find that to be acceptable.
    Yesterday, we were pleased that this committee unanimously 
passed the Food Safety Enhancement Act in a bipartisan fashion, 
which will give FDA greater authorities and resources to 
protect our food supply. I intend to build on this bipartisan 
success as we turn our next focus to medical devices and 
pharmaceuticals. As you know, we worked on this matter in a 
bipartisan way, and we worked cooperatively with the industry. 
And I call on all of my colleagues to show the same 
extraordinary cooperation they did while we worked on this 
legislation and also on the industry to understand that we seek 
to see to it that they prosper but at the same time that the 
consumers are protected. We hope we will have their help.
    Mr. Chairman, the FDA Globalization Act of 2009, 
legislation that you and I introduced earlier this year, will 
provide a solid foundation as we move forward to addressing the 
safety of medical devices and I will add also safety of 
pharmaceuticals and cosmetics.
    I want to thank the witnesses for joining us today as we 
take a close look at this important topic. I want to thank you, 
Mr. Chairman, and I want to thank my colleagues for the good 
work we did yesterday. And I want you to know I look forward to 
working with all of you to try and see to it that we carry 
forward for the protection of the American consumers on the 
balance of Food and Drug's rather shabbily handled and rather 
under-financed resources and efforts. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Chairman Dingell, and thank you for 
all you have done on this issue and others. Next is the 
gentleman from Texas, Mr. Burgess.

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

    Mr. Burgess. Thank you, Mr. Chairman. It is my firm opinion 
that this hearing should be about science and solutions, so I 
would just simply ask the question where is the Food and Drug 
Administration today? The Food and Drug Administration 
regulates more than 100,000 different medical devices 
manufactured by more than 15,000 companies. This number 
represents a spectrum of devices from all three medical device 
regulatory classes as defined by the Medical Device Amendments 
of 1976.
    As often as I complain about how many times the Food and 
Drug Administration appears before the Energy and Commerce 
Committee, and it is no small investment of their funds that 
when we bring them up here. My complaint is aimed at wasting 
the Food and Drug Administration's resources to continue 
answering questions about competence when it is clear that 
resources are the real remedy.
    If we are going to gavel in a hearing merely looking for a 
solution to any real or perceived gaps in the medical device 
approval process, then clearly I think we need to hear from the 
commissioner of the Food and Drug Administration or their 
surrogate so they can inform us what tools they need to address 
any gaps in regulatory authority to continue to ensure the 
safety of medical devices for all Americans.
    When informed of the use and possible misuse of the 510(k) 
process, the previous commission of the Food and Drug 
Administration, Dr. Andrew Von Eshenbach, dramatically stated 
that the 510(k) system is ``out of control.'' Has the approval 
process simply improved with the change of administration, or 
are there still lingering issues? That is why we should have 
the presence of the Food and Drug Administration here today.
    I am also noticing a troubling trend in our conversation 
about both devices and drugs. Last year, we held a hearing on 
biosimilars. And did we have the Food and Drug Administration 
present? No, we had the Federal Trade Commission. Now, I would 
like to think that is merely an oversight, but a pattern does 
seem to be developing which I think we should stop.
    The Food and Drug Administration is not immune from 
interference. In the 1990s, it was noted the Food and Drug 
Administration took too long to approve devices, and we may 
have the opposite situation now. And none of us must forget 
that speed sometimes kills. The evidence points to the problem 
lying in the exceptions process to the device approval, known 
as the 510(k) application, which the Food and Drug 
Administration will grant for those devices which have 
substantial equivalents on the market. We want ingenuity and 
creativity in the marketplace, and we don't want the government 
to stand in the way of that process. But safety must always be 
our foremost concern. If safety is compromised, patients will 
never seek out the treatment which these devices--and I will 
tell you as a practicing physician for over 25 years, in 
today's medical legal climate, no doctor wants to place or 
implant a device which would be less than safe.
    This is why the premarket approval process, as lengthy and 
arduous as it is, should not be overturned simply because the 
process is long. Safety cannot be timed. The device approval 
process is long for a reason. The science must rise to the 
level of trust Americans place in the stamp which says approved 
by the Food and Drug Administration.
    There are questions that need to be answered, Mr. Chairman, 
which only the Food and Drug Administration can answer, and I 
hope we will take careful consideration of what the Food and 
Drug Administration has to say before we enact any laws or make 
changes to current authority. I will yield back the balance of 
my time.
    Mr. Pallone. Thank you. Next is the gentlewoman from the 
Virgin Islands, Ms. Christensen.

       OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 
       REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS

    Ms. Christensen. Thank you, Mr. Chairman. The approval 
process for medical devices is an important issue, and I thank 
you, Chairman Pallone, for holding this follow up hearing on 
it.
    Any concerns with the approval process, application process 
needs to be resolved so that we can continue to bring these 
lifesaving products quickly and safely to the American public.
    In the practice of medicine, we are always taught to weigh 
the benefits of treatment versus the risk, and while this is 
true for devices as well as for pharmaceuticals, the approach 
to approval, both in the primary product and the secondary one, 
trying to use the pharmaceutical model for medical devices is 
perhaps worse than comparing apples to oranges and, in my 
opinion, should be avoided.
    I also think it is important to recognize that we are 
having this hearing as we are emerging from the previous 
administration and that today we are in a different 
administration, a different place, a different mindset, a 
different vision. Between 2001 and 2009, we watched scientists 
and sound science be replaced or significantly influenced by 
industry special interests and political and even religious 
ideologues on several scientific panels. And it is my sense 
that from previous hearings and the examples raised in 
testimony that the problem has not been so much the use of the 
510(k) application process but the failure to adhere to the 
process and the dictates of sound science.
    Also from what I have read thus far, what I have seen is 
that there is a backlog in the work that FDA is already 
authorized and required to do. I am sure that does have 
something to do with prior staffing and funding levels. There 
may be some minor fixing of the medical device approval process 
that needs to be done, but for the most part, it seems sound. 
And if we adhere to science and use what is already provided 
for in the process, I think we will successfully protect the 
public's health and safety. I look forward to the testimony and 
dialogue with our panelists. Thank you. I yield back.
    Mr. Pallone. Thank you. Gentleman from Georgia, Mr. 
Gingrey.

  OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Gingrey. Thank you, Mr. Chairman. Today as a result of 
advances in medical technology, we Americans enjoy access to a 
quality of health care that most nations do not. While some 
countries restrict or ration the types or amounts of drugs and 
devices that patients can access, American patients can receive 
the latest, the most advanced medical technology, such as an 
artificial hip or a knee or the latest cancer medication that 
will drastically improve and extend their lives. My 91-year-old 
mother, for example, recently had knee replacement surgery, and 
her quality of life has been dramatically improved over the 
last several months because of this surgery.
    Mr. Chairman, ensuring the safety of medical devices is an 
absolute necessity for our continued access to quality health 
care. The FDA is charged with making certain that all medical 
devices have been thoroughly tested for safety and 
effectiveness before coming to the market. It is one of the 
FDA's primary responsibilities, and I support increased efforts 
in this area.
    Unfortunately, there is an inherent risk associated with 
most modern medical procedures regardless of advances in 
technology or indeed effective oversight. It goes without 
saying that there are few absolutes in this world. Mr. 
Chairman, I am especially concerned with the GAO report 
submitted for testimony today, the report citing an FDA report 
in 2006 that cites ``the agency's ability to understand the 
risks related to the use of medical devices is limited by the 
fact that the volume of submitted reports exceeded the FDA's 
ability to consistently enter or review the reports in a 
routine manner.''
    We have spent a few months in this committee examining ways 
to expand FDA's oversight of tobacco, a product that is, by all 
accounts, outside of the agency's core mission or it was. This 
new authority will further burden an agency that, by GAO 
standards, has had shortcomings in other areas of its current 
oversight responsibilities.
    With this thought in mind, I will look forward, of course, 
to hearing the testimonies of our witnesses today. Mr. 
Chairman, I thank you for calling the hearing. And with that, I 
will yield back my time.
    Mr. Pallone. Thank you, Mr. Gingrey. Gentleman from Ohio, 
Mr. Space.
    Mr. Space. Thank you, Mr. Chairman. Very briefly, I 
appreciate you calling this hearing on what is obviously a very 
important issue, the safety of medical devices available on the 
market. I look forward to working with the committee as we 
continue to enhance a system that ensures that our consumers 
are safe while creating avenues for innovation and avenues to 
help consumers with their illnesses and afflictions and to 
strike that proper balance. I look forward to the testimony, 
and once again, thank you and Chairman Dingell for your work on 
this issue.
    Mr. Pallone. Thank you. Gentleman from Connecticut, Mr. 
Murphy.
    Mr. Murphy. Thank you, Mr. Chairman. I am looking forward 
to today's hearing as a new member of this subcommittee. In 
particular, I am looking forward to getting a better 
understanding particularly from our friends at the GAO, what 
they found as it relates to the FDA's current authorities to 
regulate varying classes of devices. Importantly, I believe we 
must determine whether the current processes that FDA uses, the 
510(k) process and the PMA process, are adequate in their 
design but have been flawed in how aggressively the FDA uses 
its authority, or if the processes themselves need to be 
updated.
    Often what Congress has found in a number of areas is that 
the regulations we intend and pass are only as good as the 
regulators and the agencies that are meant to enforce them. 
With a new administration in office, I believe that it is going 
forward to hear from them directly about their intentions as it 
relates to these processes and how they intend, if at all, to 
enforce current regulations differently than their 
predecessors.
    Again, Mr. Chairman, I thank you very much for convening 
this hearing which is fundamentally about patient safety and 
improving our response to that but also about sustaining 
important advances in medical technology. I yield back the 
balance of my time.
    Mr. Pallone. Thank you. Gentleman from Texas, Mr. Green, is 
recognized for an opening statement.

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

    Mr. Green. Mr. Chairman, I want to thank you for holding 
the hearing on the regulation of medical device safety. In 
1976, the FDA was given the authority to regulate medical 
devices by Congress. Congress directed the FDA to characterize 
the devices into three categories: class one, class two, and 
class three. In order for a manufacturer to market a device for 
sale and use, it must demonstrate to the FDA the device is safe 
and effective for its intended use.
    The manufacturers can do this in a premarket application 
process or a process which is known as 510(k) clearance 
processes. 510(k) clearance is used to bring devices marketed 
that are substantially equivalent to a previous device that the 
FDA has already cleared for marketing. The premarket 
application process is more stringent than the 510(k) process. 
The premarket application can require clinical trials to 
demonstrate the safety of the device.
    Much has been said by this committee over the past year 
with regard to safety and monitoring of our food and drug 
systems at the FDA. I could argue that the device section of 
FDA has a good system in place to monitor the safety of medical 
devices compared to food and drugs. This is one of the few 
sectors the FDA has the ability to issue mandatory recalls in 
the instance of an adverse event, and they can require the 
reporting of adverse events by hospitals, nursing homes, and 
clinical labs.
    Additionally, the FDA requires manufacturers to identify 
and monitor significant adverse events in the manufacture and 
user facility device experience database. I am looking forward 
to hearing from the witnesses today on the current state of the 
medical device safety at the FDA.
    I would also like to say we have a new FDA commissioner, 
and I am sure the new team at the FDA will be making some 
changes in all sectors of the FDA. I would think we could 
identify the issues in this hearing today that need to be 
addressed, and I hope this new team will certainly consider it. 
And again thank you for the hearing. I yield back my time.
    Mr. Pallone. Thank you, Mr. Green. Gentleman from Maryland, 
Mr. Sarbanes.

OPENING STATEMENT OF HON. JOHN P. SARBANES, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MARYLAND

    Mr. Sarbanes. Thank you, Mr. Chairman. I am looking forward 
to the testimony here today from the panel. This is another 
hearing that goes under the heading of the FDA is back or the 
FDA is coming back, however you want to look at it.
    We have had a number of hearings and markups of legislation 
designed to make sure that the FDA has the sufficient 
regulatory authority it needs to ensure that Americans have the 
confidence that these kinds of devices are safe and other 
things that are safe. That is essentially all the average 
person is looking for, that government is looking out for them 
in the way that they expect.
    I have been impressed, I guess is the word, maybe struck by 
discovering the things that the average person out there would 
assume are in place are not in place. So a lot of what we are 
doing is getting back to meeting the expectation of the 
consumer out there, that these protections are available.
    So this hearing, as others have done, is looking at whether 
there is, as I have said, the sufficient regulatory authority, 
whether the resources are in place at the FDA to do the job 
that they need to do, whether the talent is there. I believe 
that talent pool is becoming deeper and deeper by the day. And 
whether this attitude of vigilance that needs to be part of the 
agency's approach is in place. So we are very encouraged by the 
direction things are moving, and your testimony today will help 
shed even further light on that. And I yield back my time.
    Mr. Pallone. Thank you. Gentlewoman from Florida, Ms. 
Castor.

  OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF FLORIDA

    Ms. Castor. Thank you, Mr. Chairman, very much for calling 
this important hearing on medical devices and the FDA. In 
reading the GAO report on the current status of the FDA 
regulation of medical devices, I am concerned about the 
efficacy of the practices used to approve devices, particularly 
those that may impose life-or-death consequences on the 
patients that use them.
    I am also concerned that the FDA has thus far been unable 
to implement the more stringent premarket review of certain 
devices as intended by the 1976 law. FDA has not been able to 
review all of the reports of adverse events caused by devices 
released into the market, and this lack of oversight in the 
market poses a heightened risk for consumers.
    Now Americans certainly appreciate the lifesaving medical 
devices and the great innovations over the past decades. But 
with these innovations, we have seen many more advance products 
entering the market that require scrutiny and attention. And 
while we want to ensure that product review is completed in a 
timely manner, we do not want to allow under-reviewed devices 
into the market that may impose risks that could be avoided 
with a more responsible review.
    Thank you to the witnesses for being here today. I look 
forward to your testimony and recommendations. I yield back.
    Mr. Pallone. Thank you. The gentleman from Iowa, Mr. 
Braley.

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF IOWA

    Mr. Braley. Thank you, Mr. Chairman, for holding this 
hearing on medical device regulations. The safety of American 
patients is a matter of utmost importance to me and every 
member of this committee, and the issue before us today is 
truly a matter of life and death.
    The January 2009 GAO study of the 510(k) premarket 
notification process was eye-opening to say the least. As many 
here are aware, the report made the recommendation that the FDA 
expeditiously take steps to issue regulations for class three 
device types currently allowed to enter the market through the 
510(k) process by requiring premarket approval or reclassifying 
them to a lower class.
    It is astonishing to me that the 94th Congress envisioned 
that the FDA would approve class three devices through the PMA 
process, and here we sit in the 111th Congress wondering why 
this hasn't happened. Since the GAO report, FDA did take the 
step of requesting information on the safety and effectiveness 
of these devices. However, there are few details available and 
no timeframe that I am aware of outlining FDA's next steps to 
help ensure the safety of those devices.
    In addition, it is my understanding that the FDA has 
struggled with its postmarket surveillance of devices, and it 
is not meeting statutory requirements for inspecting certain 
manufacturers. This is not a good record of oversight of 
medical devices by the FDA. Amazingly, despite the limitations 
on FDA's ability to keep Americans safe, we have seen other 
efforts here in Washington undermine the only other check on 
the safety of medical devices: judicial recourse for injured 
patients. For decades Congress has recognized the importance of 
keeping American patients safe by maintaining complementary 
systems to protect consumers through the FDA and American 
courts.
    Those who oppose ensuring patient safety through judicial 
accountability often make the argument that the FDA approval--
    Mr. Pallone. I am just afraid that your mike is not on. 
What is going on? Did you press a button?
    Mr. Braley. I did.
    Mr. Pallone. It is not working.
    Mr. Braley. Is it on now? The light is lit.
    Mr. Pallone. Does that mean you can't record it or--you 
want to move to another--we don't want you not to be recorded.
    Mr. Braley. Where would you like me to begin?
    Mr. Pallone. Start there.
    Mr. Braley. You want me to start over? I apologize to 
everyone in the room for having to go through this again.
    Thank you, Mr. Chairman, for holding the hearing today on 
medical device regulations.
    Mr. Pallone. You can just continue where you were.
    Mr. Braley. All right, I think where I was right at the 
time of the interruption was talking about the importance of 
maintaining our complementary system of accountability to 
protect consumers through both the FDA and American courts.
    Those who oppose ensuring patient safety through judicial 
accountability often make the argument that FDA approval of a 
medical device is enough to ensure the safety of the device, 
yet here we sit in a hearing about FDA shortcomings, and the 
evidence is clear that we should not be betting lives on the 
efficacy of the FDA.
    That is why, in addition to ensuring a stringent medical 
device approval process through the FDA, we must pass H.R. 
1346, The Medical Device Safety Act. This legislation is needed 
to ensure that every American patient has the ability to hold 
manufacturers of defective medical devices accountable for 
injuries and deaths caused by unsafe products.
    And, yes, many of these unsafe products did receive FDA 
approval yet still resulted in recalls, injuries, and deaths. 
The Medical Device Safety Act clarifies the intention of 
Congress to keep American patients safe by maintaining our 
complementary systems to protect patients through the FDA and 
American courts.
    Many medical safety experts agree that patient safety is 
compromised when we allow the FDA to have the final say on 
device safety, and the examination today of the FDA's 
shortcomings is only further evidence of this. Strong state 
laws are critical to maintaining accountability for device 
manufacturers, and allowing the FDA to preempt these state laws 
is a surefire way to place sales over safety and profits over 
people.
    When it comes to patient safety, we must now lose sight of 
the fact that the single most important priority that all of us 
share is saving lives. So thank you, Mr. Chairman, for holding 
the hearing. I thank the witnesses, my colleagues, and the 
audience here today for recognizing the importance that this 
issue has on individual Americans' health and safety.
    [The prepared statement of Mr. Braley follows:]





    Mr. Pallone. Thank you, and I would ask unanimous consent 
that Mr. Braley's entire statement be included in the record. 
Without objection, so ordered. And I believe that concludes our 
opening statements by members of the subcommittee. So we will 
now turn to our witnesses, and I obviously want to welcome all 
of you. Let me introduce each of you. Starting on my left is 
Dr. Marcia Crosse, who is with the GAO. I don't have your 
title. What is your title?
    Ms. Crosse. Director of health care.
    Mr. Pallone. Director of health care. Okay, thanks. And 
then we have Dr. William Maisel, who is director of the Medical 
Device Safety Institute, Department of Medicine at Beth Israel 
Deaconess Medical Center in Boston and also Harvard University, 
I believe. And then we have Phillip J. Phillips who is 
independent consultant and Dr. Peter Lurie who is deputy 
director of Health Research Group for Public Citizen.
    And what we do is we have five-minute opening statements, 
and I think you know that. They become part of the hearing 
record, and then we may give you some written questions 
afterwards, hopefully within 10 days after the hearing, that we 
would ask you to respond to as well. And I will start with Dr. 
Crosse.

     STATEMENTS OF MARCIA CROSSE, DIRECTOR OF HEALTH CARE, 
  GOVERNMENT ACCOUNTABILITY OFFICE; WILLIAM H. MAISEL, M.D., 
PH.D., DIRECTOR, MEDICAL DEVICE SAFETY INSTITUTE, DEPARTMENT OF 
 MEDICINE AT BETH ISRAEL DEACONESS MEDICAL CENTER; PHILLIP J. 
   PHILLIPS, INDEPENDENT CONSULTANT; AND PETER LURIE, M.D., 
 M.P.H., DEPUTY DIRECTOR, HEALTH RESEARCH GROUP, PUBLIC CITIZEN

                   STATEMENT OF MARCIA CROSSE

    Ms. Crosse. Mr. Chairman and members of the subcommittee, I 
am pleased to be here today as you consider issues related to 
the regulation of medical devices. Americans depend on FDA to 
provide assurance that medical devices sold in the United 
States are safe and effective.
    FDA's responsibilities span premarket review of devices, 
postmarket surveillance, and inspections of manufacturing 
establishments. We have done work to examine aspects of all 
these areas and have identified a number of concerns and made 
recommendations for improvements.
    Earlier this year, GAO added FDA's oversight of medical 
products including medical devices to its list of high-risk 
areas warranting attention by Congress and the executive 
branch. Today I will provide some general background and touch 
on the findings from a number of GAO reports.
    As you know, FDA classifies medical devices into three 
classes with class one including devices with low risk to 
patients, such as bandages, and class three, including devices 
with high risk such as pacemakers. About two-thirds of medical 
devices are exempt from any FDA premarket review. These are 
mostly low-risk class one devices and some class two devices. 
FDA does little to monitor these devices including rarely 
inspecting their manufacturing facilities. I will focus my 
remarks on the remaining one-third of devices, which require 
greater regulation and oversight.
    Almost all of these devices, mostly class two, are reviewed 
by FDA through its premarket notification process known as the 
510(k) process. The remaining one percent of medical devices 
are class three devices that are subject to FDA's premarket 
approval or PMA process.
    Medical device regulation follows a least burdensome 
approach. The 510(k) process is less stringent than the PMA 
process. For 510(k) submissions, the manufacturer must 
demonstrate that the new device is substantially equivalent to 
a device legally on the market. Clinical data are generally not 
required, and substantial equivalents will normally be 
determined based on comparative device descriptions including 
performance data.
    For the more stringent PMA process, the manufacturer must 
supply evidence providing reasonable assurance that the device 
is safe and effective. Manufacturers typically submit clinical 
data for a PMA application, but FDA does not always require 
clinical data even for implantable devices. FDA may approve a 
class three device solely on the basis of engineering data. FDA 
clears or approves the vast majority of both 510(k) and PMA 
submissions. Some 90 percent of the class one and class two 
510(k) submissions are cleared for marketing, and roughly 80 
percent of PMA applications for class three devices are 
approved by FDA.
    In January 2009, we reported on a key area of concern 
regarding FDA's premarket reviews. When Congress established 
FDA's premarket review system for medical devices in 1976, it 
envisioned that all class three devices would be subject to the 
more stringent PMA process. Nonetheless, we found that more 
than 30 years after Congress acted, FDA had still not completed 
the regulatory steps necessary to require PMA reviews for some 
two dozen types of class three devices, including certain hip 
joints and other implantable devices.
    In the five-year period we reviewed, almost one-quarter of 
the class three device submissions that were cleared went 
through the less stringent 510(k) process. We recommended that 
FDA move expeditiously to address this issue, and in response, 
in April 2009, FDA began the necessary steps. However, the 
agency has not specified a timeframe for how quickly it will 
act on these devices.
    The least burdensome approach relies on postmarket studies 
to identify problems. However, FDA also faces challenges in 
postmarket surveillance of medical devices. For example, the 
agency's ability to understand the risks related to the use of 
medical devices is limited because the volume of adverse event 
reports submitted has exceeded FDA's ability to consistently 
review the reports.
    We have also found shortcomings in FDA's monitoring of 
manufacturers' compliance with postmarket study and reporting 
requirements.
    Finally, we have found that FDA has not conducted required 
inspections of manufacturing establishments which are FDA's 
primary means of assuring that the safety and effectiveness of 
devices are not jeopardized by poor manufacturing practices. In 
2008, we reported that FDA has not inspected domestic 
establishments on schedule, and inspections of foreign 
establishments greatly lagged domestic inspections.
    FDA has begun to take steps to address shortcomings related 
to inspections including opening foreign offices and hiring 
additional inspectors. However, FDA has stated that it will be 
several years before inspectors are sufficiently trained to 
conduct foreign inspections.
    Taken together, our work raises concerns about the current 
premarket and postmarket activities that are necessary for 
ensuring the safety and effectiveness of medical devices. Mr. 
Chairman, this concludes my prepared remarks. I would be happy 
to answer any questions that you or other members of the 
subcommittee may have.
    [The prepared statement of Ms. Crosse follows:]





    Mr. Pallone. Thank you, Dr. Crosse. Dr. Maisel.

                  STATEMENT OF WILLIAM MAISEL

    Dr. Maisel. Thank you. Chairman Pallone, Ranking Member 
Deal, distinguished members of the committee, my name is Dr. 
William Maisel. I am a practicing cardiologist at Beth Israel 
Deaconess Medical Center and assistant professor of medicine at 
Harvard Medical School in Boston. I also direct the Medical 
Device Safety Institute, an industry-independent, non-profit 
organization dedicated to improving the safety of medical 
devices. I have served as a consultant to the FDA's Center for 
Devices and Radiologic Health since 2003, and I have previously 
chaired the FDA's postmarket and heart device advisory panels.
    Thank you for the opportunity today to speak about medical 
device regulation and to discuss areas where improvements can 
be made to the benefit of millions of Americans who utilize 
medical devices every day.
    Recently several high-profile device safety issues have 
raised concerns about the FDA's ability to properly evaluate 
and monitor the safety and effectiveness of medical devices. 
FDA has been criticized for taking too long to identify medical 
device safety concerns and for failing to implement robust 
scientific standards for device clearance and approval.
    FDA device physicians and scientists have alleged serious 
wrongdoing at FDA, including the alteration and distortion of 
scientific and technological findings and conclusions. 
Unfortunately, these allegations divert attention from the many 
superb FDA engineers, physicians, scientists, and public 
servants who work tirelessly to ensure that only safe and 
effective medical devices reach the American public.
    We are fortunate to have the preeminent medical device 
regulatory system in the world. The U.S. Food and Drug 
Administration regulates more than 100,000 different medical 
devices manufactured by more than 15,000 companies. They 
annually receive several thousand applications for new and 
modified devices, and they are mandated by Congress to complete 
their premarket evaluations in a timely fashion.
    Unlike drugs, the medical device product life cycle from 
conception to obsolescence is short. While a drug may remain on 
the market essentially unaltered for decades, rapid 
technological device advances offer the potential to improve 
medical device performance, reduce patient suffering, improve 
health, and sometimes treat previously untreatable conditions.
    Unnecessarily slowing the device regulatory approval 
process would be akin to leaving medical device patients with 
an outdated antique telephone in an iPhone world. Nevertheless, 
it is evident that to best protect the health of American 
medical device users, the FDA must promote and enforce a higher 
scientific standard for device clearance and approval, 
particularly for higher risk devices whose abnormal performance 
is likely to have adverse effects on patient health.
    Unfortunately, due to the current FDA premarket evaluation 
process, unanswered questions regarding device safety and 
effectiveness often remain at the time of FDA clearance or 
approval. This creates the potential for a large number of 
patients to be rapidly exposed to a newly approved product in 
the absence of long-term follow-up data.
    For example, close to 268,000 patients have been implanted 
with the Medtronic Sprint Fidelis implantable defibrillator 
lead before it was recalled in October 2007 after it was 
determined that the wire was prone to fracture. A fracture of 
the lead which connects the implantable defibrillator to the 
heart may result in serious health consequences including 
painful electrical shocks or death.
    Mr. Sidney Engler, a patient of mine, was one of the 
unfortunate people to receive this lead when he had an 
implantable defibrillator placed in February 2006. Mr. Engler 
is a decorated World War II veteran, having served in Europe 
from 1943 to 1945, and on the evening of August 14, 2008, while 
preparing to retire for the evening, the simple act of removing 
his shirt over his head caused his defective defibrillator lead 
to fracture. Mr. Engler suffered a cardiac arrest in front of 
his wife. He required CPR and received numerous unnecessary 
painful shocks from his defibrillator. Fortunately due to the 
prompt response of his local EMTs, Sidney survived. Despite a 
prolonged hospital stay and months of rehabilitation, he has 
still not fully recovered.
    The FDA approved the Medtronic Sprint Fidelis defibrillator 
lead, the one in Mr. Engler's heart, as a PMA supplement in 
2004 on the basis of no human clinical data. The original 
Medtronic defibrillator lead PMA was submitted in 1992. More 
than 30 supplements had been submitted in the interim, and the 
Fidelis lead bears little resemblance to its original 
counterpart.
    In addition to a lack of human clinical performance data, 
the FDA failed to require a postmarket study to monitor the 
device's performance. The result was the widespread 
distribution of a defective product to hundreds of thousands of 
patients.
    Medical devices have enriched and extended the lives of 
countless people. The safety and performance of medical devices 
must be improved, and the frequency of medical device 
malfunctions and adverse events must be reduced. Additional 
consumer safeguards are needed. By demanding more thorough 
scientific device evaluations, the FDA can reestablish consumer 
confidence and improve its ability to protect the public's 
health. Thank you.
    [The prepared statement of Dr. Maisel follows:]





    Mr. Pallone. Thank you, Dr. Maisel. Mr. Phillips.

                STATEMENT OF PHILLIP J. PHILLIPS

    Mr. Phillips. Mr. Chairman, Mr. Ranking Member, 
subcommittee members, thank you for the opportunity to share my 
testimony with the subcommittee today. For the record, I am 
here as an independent consultant. I am not representing any 
companies, trade associations, or any special interests, and I 
receive no compensation from any source connected with any 
related to my appearance today.
    As I understand it, I am here simply to express my views of 
FDA regulation of devices based upon my 28 years of experience 
dealing with the regulation of medical devices. 24 years of 
that was with the Food and Drug Administration, and since then, 
I have had four years with the private sector.
    Keep in mind it was just a mere 33 years ago that devices 
were not subject to the regulations that they are subject to 
today. There was no FDA premarket authorization 33 years ago. 
No premarket authorization, registration listing, GMP 
inspections, and there was very little postmarket surveillance 
or postmarket vigilance.
    The 94th Congress did actually a remarkable job in 
designing the Medical Device Amendments of 1976. They created a 
three-tiered classification system for medical devices where 
the level of FDA regulation is commensurate with the risks 
associated with the devices. The system appears complex, but 
from my vantage point, it is actually very simple.
    Under the 1976 authorities, the simplest of devices were 
placed into class one subject to general controls. General 
controls include prohibitions against adulteration, 
misbranding, good manufacturing practices, labeling, 
registration listing, and a few others.
    Devices that were of greater complexity were put into class 
two subject to, at that time, it was required to meet 
performance standards. The distinction between class two and 
class three devices was that the agency has confidence that 
they knew sufficiently enough about the technologies and the 
use to conclude that performance standards could be developed 
to assure safety and effectiveness.
    The most complicated devices or complex devices, the 
higher-risk devices, where they did not have the confidence 
that general controls and special controls would assure safety 
and effectiveness were to be placed into premarket approval 
where a device-by-device demonstration of safety and 
effectiveness would be required.
    Lastly, under the medical device authorities, Congress 
provided the agency the ability to adjust classification over 
time based upon the experience and knowledge gained from the 
use of medical devices. And that was through reclassification 
processes.
    Initially there were 16 expert advisory panels that looked 
at over 1,600 generic types of devices. A generic type of 
device could include dozens of manufacturers and literally 
hundreds of individual models, not to mention components and 
accessories. The recommendations of these committees fueled the 
rule-making process and FDA-generated classification 
regulations for each and every one of these generic types of 
devices. Today I believe that there are over 1,800 generic 
types of classification regulations in the Code of Federal 
Regulations.
    The original framework exists; although, it has expanded to 
accommodate the diverse nature of medical technologies and also 
the rapidly advancing technology.
    What is a 510(k)? We have all talked about 510(k). It is a 
means for FDA to classify devices. It is not an approval. In 
fact, there is a prohibition for industry to refer to a 
clearance through a 510(k) as an approval of a device. The 
device is found substantially equivalent to go to market 
subject to the requirements that are associated with the 
generic class in which they are assigned.
    In 1981, I was a review scientist with FDA. I can remember 
my first 510(k)s. I looked at them. They were very simple 
submissions. We did side-by-side comparisons of descriptive 
data, one device versus an old device. It was actually very 
simple in the earlier days, but as technology evolved, we 
realized we had to have a greater framework and structure in 
which to render substantial equivalence determinations.
    Today's 510(k)s are replete with performance data on the 
new devices. Simply examine any 510(k) or look at FDA guidance 
document, and you will see what FDA's scientific expectations 
are for new devices. Reviewers get largely what they demand, 
and again, simply look at the number of additional information 
requests and look at the responses. You will find industry 
provides the reviewers exactly what they need in order to be 
able to support their clearances.
    The PMA process is very rigorous and demanding. It is not 
only high standards to get to market, but it is almost like a 
mortgage on a home. Once you are successful and you get your 
PMA application, it is actually a significant burden to stay on 
the market because of the filing of voluminous reports and 
supplements to the Food and Drugs Administration.
    It is sort of an interesting dichotomy that I will bring to 
your attention because innovations come from generally small 
entrepreneurial companies, and those are the least able to 
comply with the rigorous PMA requirements. With rare exception, 
only the large companies are able to play in the PMA arena. My 
bottom line is I think that there is a place for the PMA 
process, and it should be used whenever it is warranted.
    As far as my recommendations, I will leave you with just 
simply four. We have new administration at the Food and Drug 
Administration, and I think that we should empower Dr. Hamburg 
and Dr. Sharpstein to look at the medical device program, 
identify any gaps that exist and formulate a strategy for 
dealing with those gaps.
    The class three devices, I agree completely with the 
General Accounting Office. They need to be dealt with either 
through reclassification or premarket approval, one or the 
other.
    There is another interesting issue that I will bring to 
your attention, which I think is also a gap. It is a deficit in 
the way that devices are regulated. For class two devices, they 
were supposed to be performance standards. The agency has never 
promulgated performance standards, actually one dealing with 
the safety of leads associated with electrical products that 
come in contact with patients. But by and large, there are no 
performance standards, and there are a relatively small number 
of special controls. Special controls replaced performance 
standards with the Safe Medical Devices Act of 1990.
    I believe that the agency should develop special controls 
for everything that is in class three, just like there should 
be premarket approval for everything that is--excuse me. There 
should be special controls for everything in class two just 
like there should be premarket approval for every class three 
medical device.
    The last thing I will say is that the reclassification 
process needs to be vitalized, not revitalized because it has 
never been a really functional system. The agency and consumers 
need to have the ability to adjust the classification of 
devices based upon new information. With that, that is the end 
of my remarks, and I look forward to questions.
    [The prepared statement of Mr. Phillips follows:]





    Mr. Pallone. Thank you, Mr. Phillips. I want to hear from 
Dr. Lurie, and we will right now. But I did want to mention 
unfortunately that that bell was for 26 amendments that we will 
be--28 amendments that we will be voting on. So we are going to 
hear from Dr. Lurie. Then we are going to go to the floor. It 
says right now that the first is 15 minutes, and each of them 
are five. I am hoping that when we get there, they will reduce 
it to two. But we are talking probably at least an hour and a 
half.
    So we are going to hear from Dr. Lurie and then we will go 
vote. Hopefully be back by around noon, maybe earlier. I doubt 
it. And then we will take questions. Dr. Lurie.

                    STATEMENT OF PETER LURIE

    Dr. Lurie. Chairman Pallone, members of the committee, 
thank you for the opportunity to address you. Our comments this 
morning are primarily about the premarket review of medical 
devices and not about postmarket issues at all.
    I can summarize my comments as follows. The bad news is 
that device review, particularly with respect to effectiveness 
at the FDA is severely damaged. But the good news is that 
actions that the FDA could take today without any additional 
regulatory or statutory authority, in addition to the powers 
that could be granted by this committee and by the Congress, 
could make an enormous difference in improving the quality of 
medical device review.
    We are going to look at three separate problems in medical 
device review and give examples from recent regulatory 
proceedings to illustrate each of those. Problem one, the 
standard for approval of medical devices is lower than the 
standard of approval for drugs. By statute, the approval 
standards for devices is--for drugs, I am sorry--is 
``substantial evidence of effectiveness.'' Whereas the sponsor 
of a new device need only demonstrate ``a reasonable assurance 
of safety and effectiveness.''
    What this means is that whereas you might get two clinical 
trials for a drug to be approved, a single study, if you even 
get that, is the norm for devices. In fact, FDA regulations 
even permit the absence of well-controlled investigations under 
PMA.
    In practice for consumers what this means is that data that 
would never be considered sufficient to support the approval of 
a drug can result in the approval of a device and thus to treat 
the very same condition as my example will show, thus 
potentially diverting patients from effective and well-proven 
devices to less effective and less--excuse me--from diverting 
patients from effective and well-proven drugs to less effective 
and less well-proven devices.
    Consider the Cyberonic's vagus nerve stimulator. It is a 
surgically implanted device for depression. A randomized 
control trial was done, and it failed to demonstrate any 
significant impact upon depression. However, the company was 
allowed to rely upon the kind of data that the drug division at 
the FDA would not even look at. They were allowed to look at 
follow-up data at a year using a control group that was not 
randomized. It was not blinded, using patients that were 
recruited at different times, and in which the patients were 
allowed to modify the antidepressant drugs and even get 
electroshock therapy.
    An expert at the FDA's drug center told the device center 
that with similar data for an antidepressant drug, that the 
drug center would not even have allowed the filing of an NDA. 
Yet instead what happened was the center for devices, the 
director consulted with more than 20 FDA scientists and 
officials, not one of whom recommended approval of the device. 
And he overruled all of them, and the product got approved.
    Fortunately, CMS has taken the position that the product is 
in fact not effective and is not reimbursing. So it has not 
been widely used.
    Now, the second two problems that I want to talk about deal 
with the 510(k). We have already heard a lot about them. We 
have heard already how, according to the GAO, the 510(k) 
process is generally less stringent, less expensive, and 
faster. We have heard how only a small minority of 510(k) 
submissions contain any clinical data.
    In fact the FDA says ``it does not attempt to address all 
of the issues that would be answered in a PMA in its review of 
510(k)s.'' Now, the 510(k) pathway itself is not the problem. 
The problem is that there are two ways to get into the 510(k) 
process, and in practice, in part because of legislation and in 
part because of FDA practice, these are not interpreted in a 
rigorous way. And so products that ought to be going through 
PMA instead go through 510(k).
    So that leads to problem two, permissive interpretation of 
same intended use. That is one of the two elements that can get 
you into 510(k). The best example here is ReGen's Menaflex 
Collagen Scaffold, which is a device implanted during 
arthroscopic surgery to replace damaged knee cartilage.
    Now, after consulting with the FDA, ReGen began a trial to 
support a PMA, which was a well-done, two-year, randomized 
trial comparing partial meniscus removal to partial meniscus 
removal with the product, the MCS. Only problem was this study 
was stone cold negative. Absolutely no evidence of benefit 
whatsoever.
    Now, after the trial was complete, the FDA allowed the 
company to shift courses and submit a 510(k). Why were they 
able to do this? Because current agency practices provide for 
permissive interpretations of same intended use. They say ``our 
scientific expertise enables us to exercise considerable 
discretion in construing intended uses.''
    Now, the first two 510(k)s were rejected, and in a third 
one, ReGen said that the predicate device, the device to which 
it needs to be shown to be substantially similar, were surgical 
meshes, surgical meshes that do not plainly seem to be for the 
same intended use at all. Rotator cuff mesh in the shoulder, 
anal fistula plug, and hernia repair graft. These don't sound 
like devices that belong in the knee.
    In fact, an FDA reviewer pointed out that none of these 
meshes that the company had cited was implanted in a weight-
bearing joint or intended to facilitate the regrowth of 
articular cartilage. So the result was these plainly dissimilar 
devices counted as ``same intended use.''
    Of course, the company downplayed the results from the 
randomized control trial. It said that the bench testing data, 
like whether or not you could pull the cartilage replacement 
apart, or whether it could hold sutures well, should provide 
the primary basis even though it had already done a well-done 
randomized control trial that showed that the product had no 
public health benefit whatsoever.
    And it made this point before an advisory committee saying 
that the decision for the advisory committee should be based 
upon the function of this device as a surgical mesh and not the 
ultimate clinical outcome. Let me tell you, as a doctor, this 
is really very painful even to think about. The clinical 
outcomes are ones that matter to us, and we hear Dr. Hamburg in 
particular talking about putting the agency on a public health 
footing, this is what, I think, she must be talking about.
    Subsequently a number of irregularities in the advisory 
committee review of this product came to light. It turned out 
that ReGen was permitted early input into the questions posed 
to the advisory committee, into who made the FDA presentation 
at the meeting, people who were not the original reviewers of 
the product, and even standing advisory committee members who 
were available to attend the meeting were replaced by 
clinicians thought more likely to favor the device. And all of 
the positive votes for this device came from the replacement 
advisory committee members. So there really were very large 
irregularities here. FDA is looking into this, and we hope that 
some of this will be explored further.
    The third problem which might get you into 501(k) if not 
properly enforced is different technological characteristics. 
The 1990 amendments to the Food, Drug, and Cosmetic Act provide 
for products with different technological characteristics to be 
predicates as long as no new issues of safety or effectiveness 
are raised.
    The problem is that this has lead to predicates which are 
plainly different from the device up for approval, and thus 
products go through 501(k) when they should instead be going 
through PMA. The example here is transcranial magnetic 
stimulation, or TMS, also a device intended to treat 
depression. The agency permitted TMS to be reviewed under 
501(k) with electroshock therapy as the predicate device, even 
though electroshock is toxic involves the administration of the 
electrical currents to produce a generalized seizure, whereas 
TMS simply applies a magnetic field to a specific region of the 
brain.
    They did a randomized control trial. The results showed 
that the effectiveness of this product was statistically 
nonsignificant and clinically minor. I am not going to get into 
the details here, but this product was eventually approved 
through a process called the de novo process, which is not the 
subject of my testimony today. But suffice it to say they 
couldn't have got to de novo had they not got to 510(k). And 
they could not have got to 510(k) without invoking the 
different technological characteristics provision. So one thing 
leads to another, and now we have this device that barely works 
that is on the market.
    Let me conclude with two contextual matters and then the 
final conclusion. The two contextual matters are that the 
matter of the least burdensome means of showing effectiveness 
for devices that I believe Dr. Crosse referred to.
    Mr. Pallone. Mr. Lurie, I just want the members to know 
there is only about three minutes left. I want to hear the rest 
of it, but just so you know there is only three minutes left.
    Dr. Lurie. I will certainly finish well within that time.
    Mr. Pallone. OK.
    Dr. Lurie. This gives the industry recourse to challenge 
many requests that it regards as onerous. Indeed, ReGen evoked 
this very language when the FDA was considering the unfavorable 
findings of its randomized trial. So that is the first 
contextual issue.
    The second is that in general the FDA has permitted 
scientific approaches that fall well short of rigorous, and we 
have listed a number of things just from the examples cited in 
this testimony are really unacceptable from a scientific point 
of view.
    Depending on the specific case, these lax scientific 
standards can be the result of any combination of the lower 
standard for device approval, the inappropriate routing of 
devices through 510(k) instead of PMA, the least burdensome 
requirement, or simply the lack of rigor at the agency level.
    Now, each of the issues that have been identified in this 
testimony can be remedied by a combination of agency practice, 
regulation, and legislation. And to the former, even today 
under existing authority, the agency can require greater 
scientific rigor. It can send more devices through the PMA, and 
it can tighten the same intended use requirements.
    But legislation could also make a difference. It could 
address all three of the problems that I focused on today: the 
lower approval standards for devices than for drugs, the 
permissive interpretation of same intended use, and the 
different technological characteristics loophole. We call on 
the Congress to pass exactly those three kinds of legislation. 
Thank you.
    [The prepared statement of Dr. Lurie follows:]





    Mr. Pallone. Thank you, Dr. Lurie. Now, as I said, we have 
28 votes, so I am going to say at least an hour and 15 minutes, 
you know. We will probably be back around 12:00, between 12:00 
and 12:30. I think you all said you could stay beyond that 
though. So we should be all right. Without further ado, the 
subcommittee is in recess.
    [Recess.]
    Mr. Pallone. The subcommittee will reconvene. Let me 
apologize. We really thought we would be done by 12:00 or 12:30 
at the latest, and obviously that is not the case. So I really 
appreciate the fact that the three of you stayed. I know that 
Dr. Lurie said he actually had to leave at 12:30 anyway, but I 
appreciate the fact that you stayed here all this time.
    The process, basically each of us, each member is allowed 
to ask you questions for five minutes. And then, as said, there 
may be written questions after particularly since what happened 
today, there will probably a lot of written questions. And you 
should get those within 10 days or so.
    So I am going to start by recognizing myself for five 
minutes. You know what we are trying to do obviously is see if 
there is a need for legislation to correct the concerns that 
many of you have raised about the medical device approval 
process. And that is how you could be most helpful to us if you 
have suggestions. There is, of course, a bill that Mr. Dingell 
mentioned. Part of his--well it is actually his and Bart Stupak 
and my bill and others, but, you know, we separated out the 
food safety, but we still have the medical device and the drugs 
and the other provisions.
    But that, in my mind, is more oriented towards inspections, 
lack of inspection, lack of resources. I don't believe that it 
directly addresses whether we should change the procedure in 
terms of, you know, approval. I don't think it relates to that. 
So that is kind of what I want to get answers from you on, and 
I guess my concern is that I don't think the issue is whether 
or not we should have a 510(k) process, although if any of you 
feel we shouldn't, you know, tell us.
    But I don't think the issue is whether or not we should 
have it, but whether it is overly used and essentially abused, 
and whether or not this grandfathering, which was supposed to 
be essentially abolished, you know, or should be abolished and 
how long that should take or what the process should be to make 
sure that that is eliminated, if that is what you feel.
    And I guess I will start with Dr. Maisel, but I will ask 
any of you the same question. It sounds to me like the 510(k) 
process is appropriate for a product that has the same effect 
as products that are currently safely and effectively on the 
market, almost like a generic, which maybe I shouldn't use. But 
I will use it because I kind of understand that.
    But if a product has a new effect or is used in a new way, 
then it is important to go through the more rigorous premarket 
approval process so that the patient can know that this new 
technology will actually work and work safely.
    So I guess what I am asking is is my analysis of that 
correct? And if that is true, is the problem that, you know, we 
have essentially extended this 510(k) process beyond products 
that are currently safely and effectively on the market and the 
products that are going to be very similar to those, and that 
somehow we have gotten beyond that? And I am just asking that 
very generally. And I will start with Dr. Maisel.
    Dr. Maisel. Well, I think you have it essentially correct. 
I think Congress actually did a pretty great job in forming a 
device law that correlates the risk of the device and the risk 
to the patient with the degree of rigor in which a product is 
reviewed. The problem with the 510(k), you do have it right. In 
order to be substantially equivalent, it needs to have the same 
intended use and the same technological characteristics, and if 
the technological characteristics are different, then it 
can't--those changes can't affect the safety and effectiveness.
    What happens is that there is a lot of latitude that the 
FDA has in making those decisions. There is a lot of latitude 
in making a decision about whether a device has the same 
intended uses we have heard this morning already, and there is 
no real good definition of what differences in technological 
characteristics should warrant the more thorough evaluation.
    There is a lot of reliance on bench testing, on testing in 
the laboratory of these products, which is fine except that 
there is no great correlation that that bench testing predicts 
clinical performance. And so there is this disconnect between 
the tests that are being done and how the product actually 
performs.
    The other loophole that I think is a big loophole that we 
haven't really touched on is that companies can change their 
product and not file a 510(k) and not tell the FDA that they 
are marketing a different device. You do not have to file a 
510(k) if a company changes a device and the company decides 
that there is no change in the safety and effectiveness of that 
device. Not the FDA. If the company decides that there is no 
change in safety and effectiveness and it is the same intended 
use, then they don't even have to tell the FDA that they have 
modified their device.
    And there is a great example of this. The Edwards ET Logics 
valve was on the market for two and a half years. Many patients 
were implanted with it, and the FDA had no idea that it was 
even on the market. And finally they became aware it was on the 
market. They went to the company, and the company had followed 
FDA guidance that says if you change your device and there is 
no change in the safety and effectiveness, you don't need to 
tell us about it.
    I mean that is a huge loophole that needs to be closed, and 
it is not that hard to close it. It requires legislation that 
says companies need to tell the FDA whenever they change a 
device and whenever they are marketing a modified 510(k) 
product, whether or not it affects safety and effectiveness.
    Mr. Pallone. Now, I am going to ask the other two to 
respond to, although I know the time is almost up. But you have 
been waiting here for six hours, so I am not going to worry 
about the time much. But you basically feel that we should have 
a 510(k) process? None of you--well, I will ask the others, but 
you are not advocating we should not have it but that it is 
just overutilized. It is much too subjective.
    Dr. Maisel. I think it is overused, and it would have been 
interesting to ask Congress back in 1976, their vision of what 
percentage of products would have gone through the PMA process. 
I can't imagine that they imagined only one percent of the 
devices would go through PMA process.
    Mr. Pallone. All right, but now what about this 
grandfathering? I mean I get so confused because it seems to me 
that you could have a device that was pre-'74 I guess, whenever 
we first passed the approval act, and that is grandfathered. 
Then you use the 510 to get approval for a device that is based 
on that grandfathered one, and then you can even use another 
device to grandfather, you know, to piggyback on the second 
one. So we have like, you know, generations--tell me if I am 
wrong--generations of devices that go back to this grandfather 
and never went through premarket approval.
    I mean how would you have us deal with that?
    Dr. Maisel. I have to say that I would be interested in 
what Dr. Crosse has to say because she spent a lot of time 
obviously looking at the 510(k) program. I don't view that as a 
huge problem right now. I think the bigger problem is the FDA's 
assessment of the devices that are coming in front of them and 
the rigor with which they evaluate those devices, the level at 
which the bar is set for the evidence that the device is safe 
and effective. I don't lose sleep over the grandfather issue.
    Mr. Pallone. Okay. Well I will let the other two answer if 
you will, and then we will go to Lois, and we will see who else 
shows up. Go ahead, either one of you. Mr. Phillips?
    Mr. Phillips. I think there should be a 510(k) process 
because I will tell you I think that it has served consumers 
very well throughout the years. And I think that if you look at 
the totality of all decisions, we are talking about over a 
quarter million devices that have been cleared through the 
510(k) process since 1976. And I think by and large, the 
devices that have become controversial are actually very few. 
So I think that there is overwhelming evidence that the program 
is actually a very valuable program.
    Mr. Chairman, you asked a question about the 
grandfathering, and I appreciate Dr. Maisel's answer to that 
because I really don't think that it is a concern. All of those 
products that were grandfathered did go through an evaluation 
by experts both on independent advisory committees--and this 
is--in my testimony, I refer to 16 different expert advisory 
panels that reviewed all of these different types of devices. 
And they went through all of the different generic types. They 
looked at available information that was in the public domain 
at that time, which was published, peer-reviewed literature.
    And they also factored in their own expertise, and they 
made their recommendations to the agency regarding what 
classifications those products should be placed in. And I think 
that actually that process had a tremendous amount of 
integrity.
    As I said this morning, I think that part of the issues 
that we are all dealing with here or struggling with is the 
fact that in 1976 Congress envisioned that all of these class 
two products would be the subject of performance standards. And 
the agency was not successful in developing performance 
standards because the process was too resource-intensive. That 
was the agency's explanation then, and I can tell you it is the 
explanation today.
    Congress did allow the agency to switch from performance 
standards to what is called special controls, which are very 
flexible means of trying to mitigate risks associated with 
devices. And it can include actually clinical testing. So when 
I made the recommendation this morning that serious 
consideration be given to developing special controls for all 
devices in class three, what I was looking at was the situation 
that I think all of the panelists were dealing with, and that 
is these isolated incidents or clearances where there is 
criticism about not having proper clinical data or having 
proper testing.
    I think there is a means under the existing statute to 
actually get all of those things in place for all of these 
problems at least as an opening measure before somebody thinks 
about opening the statute.
    Mr. Pallone. Okay, thank you. Dr. Crosse, and thank you for 
all you have done with the GAO report and all.
    Ms. Crosse. Certainly. You know we looked at this issue 
quite extensively, and I would have to agree that the 510(k) 
process in general seems to be working well and as intended. 
When we looked at the percentage of device applications--not 
applications, I am sorry. Under the 510(k) process, device 
submissions that came in, you know, 86 percent of them were 
judged as having both the same intended use and the same 
technology, and only 14 percent as having a different 
technology that needed to be evaluated for whether it posed any 
risk to the safety of the device.
    So the vast majority there are coming in as the same 
intended use and the same technological characteristics. I 
think the question is exactly what Dr. Maisel said, is the 
evidence of that that FDA is accepting adequate. Where we have 
had some problems in looking at FDA's reviews of devices, both 
under PMAs and under the 510(k)s is the kind of information 
that FDA is accepting as sufficient to make their 
determinations.
    And that is really something that we are not qualified in 
any individual case to question, to say no, really we have a 
different opinion about this technology. So we are not coming 
out and pointing to specific devices, but I think overall you 
do have a question about whether or not there is a greater need 
for clinical data in some instances and whether FDA is 
accepting that small companies can't be expected to have the 
same level of clinical information as a large company would be 
expected to produce or that you can't have the same kind of 
studies being conducted and that this is enough.
    You know so we have seen some evidence of that, but it is a 
small number of cases where we have seen that occurring. And 
so, you know, it is not a question of legislative authority. It 
is a question of the application of that in the scientific 
review.
    Mr. Pallone. Okay, thank you. Our vice chair, gentleman 
from California, Ms. Capps.
    Ms. Capps. Thank you. Excuse me. I am going to try to avoid 
the questions that you have asked. Since it is just the two of 
us, we will try to see how much we can cover quickly. Thank you 
very much on my behalf as well for your patience with today's 
proceedings.
    I have two different topics to bring up. I will address the 
first one to Mr. Phillips, but I actually would love to get 
some comment from anyone who wants to on this topic, both of 
these topics.
    One, the 510(k) process is only one component of the 
regulatory controls composed on medical devices intended to 
ensure safety and efficacy. In fact, the U.S. medical device 
regulations have been models for regulatory processes developed 
in some other countries as well. Mr. Phillips, can you describe 
or does anyone want to describe other regulatory controls 
besides the 510(k) and their roles in protecting patients and 
health care professionals?
    And let me just ask the question, the second one on this 
topic. I know there are concerns about these different elements 
of the approval and regulatory process. Does anyone want to 
comment on how congressional efforts to give the FDA more 
funding and resources could help this 510(k) and other 
processes as well to improve and be more effective?
    Mr. Phillips. Yes, ma'am. If you look at the controls that 
are available to the agency to ensure safety and effectiveness, 
they actually have a wide variety of different controls. 
Premarket notification is actually what is referred to as one 
of the general controls for medical devices. That is under the 
1976 amendments.
    Other general controls include provisions against 
adulteration and misbranding. There are labeling requirements. 
There is registration listing, which basically identifies 
establishments so that they can do, the agency can do 
inspections. So GNP inspections would be part of the general 
controls.
    The same thing with some postmarket surveillance 
activities, for example, records and reports like medical 
device reporting. Those are referred to as the general 
controls, and they apply to all medical devices regardless of 
the class because they apply to class one, two, and three.
    It is interesting because premarket notification is a 
general control that applies to all products. But under the FDA 
Modernization Act of 1997, most class one devices were exempted 
from 510(k) review. In fact, the agency had the authority to 
reserve certain devices if they met what was called the 
reserved criteria. And there is probably 10 percent of the 
class one medical devices that still come in under 510(k).
    It is almost as if that action by Congress changed 
premarket notification or 510(k) from more than just a general 
control to a special control that would apply primarily to 
class two medical devices. I mean in reality that is what has 
really happened.
    It is also interesting because if you look at what the 
agency has under special controls as tools that can ensure 
safety and effectiveness, as I said in my morning testimony, 
they have a tremendous amount of controls that are available to 
them to apply to devices as they believe necessary from not 
just premarket notification but, you know, patient registries 
in a postmarket period.
    There can be clinical data that is required. There can be 
specialized labeling. There can be agency guidelines that are 
put into place. So there is a wide variety of different tools 
that can be applied.
    For the class two devices, it is difficult to describe how 
well those controls can ensure safety and effectiveness because 
by and large, class two devices today are not subject to 
special controls. And that was sort of the problem that I 
pointed to this morning because I think that would be one of 
the first things that I would think of is that there could be 
more special controls, guidance documents, that looks at the 
risks that are associated with class two devices and figuring 
out what are the proper mitigation measures that address those 
risks. And again I think that the agency has really a wide 
variety of things that are available to them should they elect 
to apply those for the regulation of devices.
    As far as, you know, what efforts or funding could Congress 
ensure that the agency has? I am not an advocate for just 
simply increasing FDA's budget by any specific amount or any 
specific percentage. I have heard of people saying well, the 
agency should have their budget doubled. I think that the 
agency should receive the funding that could allow them to take 
care of the priority issues that need to be taken care of.
    And clearly I think the two that come to my mind is 
inspections because clearly there is no question. The agency 
has to have more of a presence in facilities, whether it is 
class one, two, or three, than what they do today. That is one.
    I think in the postmarket area, I think again that is an 
area where there needs to be resources applied at the agency, 
not just necessarily in personnel with the analysts that can 
look at MDR reports or adverse events that are coming into the 
agency, but also to improve the infrastructure that they have 
in order to be able to process the reports that come in. I 
think as Marcia Crosse indicated in her testimony, it is a 
tremendous amount of data that is coming into the agency. And I 
really don't think they are equipped to deal with that 
information as efficiently as what they really should. So I 
think that that is a big issue.
    In the premarket area, you know, we have already said that 
for the class threes, the agency has already moved out to take 
the very first steps to ensure that they get the class three 
devices subject to premarket approval. The steps that they have 
taken so far are the easy steps. The more difficult steps are 
assuming that the PMAs come in for all of these different 
products. The agency is going to have to be able to process 
those applications, and they are not going to be able to 
process them at existing staffing levels. So with that, I will 
close my answer.
    Ms. Capps. Okay, Mr. Chairman, do I have your permission to 
continue as though it was almost like a second round, or would 
you rather me stop? I have another question.
    Mr. Pallone. No, I think you continue and then Mr. Burgess 
is here. And we will let him continue. Are you able to stay a 
few more minutes, Dr. Maisel?
    Dr. Maisel. Yes, I am.
    Mr. Pallone. Okay, go ahead.
    Ms. Capps. Thank you very much. Since it has been this 
long, I feel like maybe we want to have a little more robust 
conversation than we might have otherwise. In other words, I am 
interpreting what you are saying, and I want to see if anyone 
else wants to add to it, the 510(k) model, while a good one, 
isn't offering--there might be some others like inspection and 
postmarkets that, if there were more resources, could also add 
to the robustness of the regulations and the evaluation in 
achieving the goals. Would you like to comment?
    Ms. Crosse. Well, yes, I would say in fact that the process 
requires the postmarket steps, and in fact, it is constructed 
to depend upon the postmarket steps. And that has been where 
the greatest problems have been with FDA's resources and 
ability to attend to the kinds of adverse event reports that 
come in that let them know about problems that couldn't 
necessarily be known in advance until they are out in 
widespread use.
    Ms. Capps. And you could make the correlation--I am not 
asking you to define it--between the amount of resources that, 
if you are limited you are going to put them into the 510(k). 
But if you had more, you would put more because inspections 
require more resources obviously.
    Ms. Crosse. Well, it is that, and it is structured under 
the user fees that there is funding for the premarket steps. 
The user fees are paying for the premarket steps----
    Ms. Capps. But not the postmarket.
    Ms. Crosse [continuing]. But had not been, until very 
recently, available to pay for some of these postmarket steps. 
There is now additional funding for the inspections, and I 
would concur that that has been a great area of weakness and 
that they are now beginning to address.
    They are also beginning to address some of their IT 
infrastructure problems that have limited their ability to 
analyze some of the information that they have even when they 
have received it. And so I think that they are beginning to 
take steps, but I see particular weaknesses on the postmarket 
side.
    Ms. Capps. Okay, any----
    Dr. Maisel. May I respond to that?
    Ms. Capps. Yes, please.
    Dr. Maisel. So I agree that certainly increased resources 
will undoubtedly help the FDA. I think it would be impossible 
to dispute that. And I agree that the postmarket area and areas 
like inspections will help. I think we would be naive to think 
that throwing money at the issue is going to solve the problem.
    Ms. Capps. I agree.
    Dr. Maisel. And I am not saying you are implying that, but 
we could give the FDA unlimited resources. But if we don't 
change their approach to evaluating products, if we don't 
change the science-based evaluations, then we are still going 
to be faced with problems.
    Ms. Capps. I see. I will turn to another topic then with 
permission. You know it is interesting. Usually when we think 
of FDA, we think of safety. But effectiveness is just--we 
always say safety and effectiveness. And today we focused 
primarily on safety, but whether a device works or not is, I 
would submit, equally important. I am sure you agree. The 
history of Food and Drug and Cosmetic Act includes many 
instances where Congress has had to tighten regulations because 
the products being marketed weren't living up to their goals 
and were, in fact, ineffective.
    Despite this history, we hear from some that we need to 
keep the barriers low even for potentially lifesaving devices 
to enter the market. To do otherwise, these critics argue, 
could stifle innovation and keep patients from treatments that 
may heal them.
    But what concerns me is that if there is not enough study 
of the effectiveness of devices before they are marketed, 
patients and their doctors are forced to make decisions about 
whether or not to use the device that really may have never 
adequately been demonstrated to work.
    Mr. Maisel, maybe I will start with you this time. In this 
case, I will just use an example because I was a coauthor. I 
have been a school nurse, and so I know about external 
defibrillators. This panel has endorsed Ms. Sutton's bill, the 
Josh Miller--and he was a student--Hearts Act in a bipartisan 
fashion because this bill would put lifesaving devices in every 
school. It is a big step. Don't always think of schools as 
being a place where they are needed, but there is evidence that 
they have been.
    I do agree with that policy, but I also am very concerned 
particularly with not fully developed people that these devices 
work. Dr. Maisel, can you tell us about that particular 
situation with your experience?
    Dr. Maisel. I think you have picked out a very important 
medical device, external defibrillators, which have been proven 
in well-conducted clinical studies to save lives.
    Ms. Capps. Yes.
    Dr. Maisel. Sudden cardiac deaths claim about 330,000 lives 
each year in this country. It kills more people than AIDS and 
breast cancer combined. I mean it is a huge deal, and we are 
fortunate to have a good therapy. Now, interestingly the 
automatic external defibrillator is one of the class three 
510(k) devices mentioned in the GAO report.
    And if you doubt that there is an issue with the 510(k) 
program, this is the poster child for the problem because since 
1996, there have been 52 recalls affecting automatic external 
defibrillators. There has been over 300,000 AEDs that have been 
recalled. One in five AEDs out in distribution in this country 
have been recalled.
    Ms. Capps. Yet they were put out.
    Dr. Maisel. They are put out, and the challenge of--I think 
it is unrealistic and impossible to think that every iteration 
of an external defibrillator is going to be clinically 
evaluated. I don't think it should be, and I don't think it can 
be. But we need to figure out a better way to evaluate these 
devices----
    Ms. Capps. You have an idea?
    Dr. Maisel [continuing]. Instead of approving them each 
time based on the fact that it is as good as the one that just 
came----
    Ms. Capps. Right.
    Dr. Maisel [continuing]. Down the line. I think another 
thing, another important point you made was the safety and 
effectiveness point.
    Ms. Capps. Right.
    Dr. Maisel. It is impossible to assess safety without 
knowing the effectiveness. If I told you a medical device kills 
two percent of the people who get it and ask you is that safe 
or not, you can't answer the question. Compared to what? You 
need to know, you know, maybe the disease is 100 percent fatal 
without the device and everyone lives who gets it. So two 
percent sounds great. Maybe no one dies without the device and 
two percent die with it, and then it is terrible. You need to 
know effectiveness if you are going to evaluate safety.
    Ms. Capps. I will ask all three of you. Do you think we 
have adequate resources or methodology to do that? Maybe that 
is too harsh a question. What should we be doing in this area 
that we are not doing now?
    Ms. Crosse. I am not certain that it is an issue of either 
resources or methodology. I mean it seems to me it is an 
application of current existing approaches or an ability 
perhaps in that particular instance for the agency to say, you 
know, you can only have so many iterations before you have to 
provide some other sort of information, which might be a 
different regulatory approach. But it is not clear that there 
is evidence to establish that. It is not something we have 
really directly looked at.
    Ms. Capps. Is it that there is not evidence to establish it 
or we have not asked those kind of questions?
    Ms. Crosse. I think probably either.
    Ms. Capps. Is it in that area that we should push?
    Ms. Crosse. We haven't got anything that I would be able to 
give you an answer about how one might go about or what would 
be necessary.
    Ms. Capps. Well, let me just focus on the recalls of the 
AED. Those came, I imagine, because people had untoward effects 
or didn't work when they were----
    Dr. Maisel. So the FDA and our country has a medical device 
reporting system, and so adverse events that manufacturers 
become aware of that cause harm to patients are required to be 
reported to the FDA.
    Ms. Capps. Right.
    Dr. Maisel. And companies become aware of these things, and 
so since 1996, there have been approximately 370 deaths 
associated with failure of AEDs. And so in response to device 
failures that get reported, companies become aware of them and 
recall their product because they have defects, whether they 
are related to the circuitry in the device, battery function. 
These are complicated devices, and things happen to them.
    Ms. Capps. Are they recalled at the insistence of FDA?
    Dr. Maisel. Virtually every recall of most devices are 
``voluntary'' recalls by the manufacturer, meaning that the 
manufacturer becomes aware of a problem and then chooses to 
issue a voluntary recall, sometimes with the coercion or urging 
by the FDA. And there are rare occasions where the FDA will 
issue a recall if the company doesn't. But most of them are 
voluntary.
    Ms. Capps. Is there anything within the Food and Drug 
Administration that has jurisdiction in this area, where, if 
there is a recall, that there is an action that is taken by the 
FDA?
    Ms. Crosse. Well, FDA has the authority both to order a 
recall or certainly to evaluate the information, urge the 
company, alert them to the problems that they are seeing and 
the adverse event data if the company is not aware of it 
already. Usually the company would become aware of----
    Ms. Capps. Right.
    Ms. Crosse [continuing]. Something first, but, you know, 
one could argue this is an example of the system working as it 
is designed that when adverse events are identified, recalls 
occur. I think the question then becomes what does FDA do with 
that information? If they see a pattern, what then feeds back 
into their evaluations of subsequent devices when those 
applications come in? And I can't answer that question for 
AEDs.
    Dr. Maisel. I would also say if I were designing the FDA in 
a postmarket surveillance system, I would want the FDA to be 
the one finding some of the problems. It is extremely rare that 
they are actually the ones that identify the postmarket problem 
despite the fact that they are asking for data.
    Almost always it is the clinical community that comes up 
with the problem or the manufacturer gets reports and 
identifies it and reports it to the FDA. It is very rare that 
the FDA combs their database and their reports and comes up 
with an a-ha moment where they have identified something.
    Ms. Capps. Well, Mr. Chairman, this is not a point I want 
to belabor, but it seems to me a point of perhaps interest of 
further discussion at another time. It appears to me that when 
something comes to light, when the public knows it, then 
something happens. But I am also mindful that you can't always 
count on that to happen necessarily. But I will leave it at 
that, and thank you very much.
    Mr. Pallone. Thank you. Thanks so much. Mr. Burgess.
    Mr. Burgess. Thank you, Mr. Chairman. I thank the witnesses 
for bearing with us. I hope you were able to watch the drama on 
television in the House floor all day, spellbinding. I am sure 
you were on the edge of your seats through all of those 
reconsiderations.
    Dr. Crosse, on the 510(k) process we have been discussing, 
that is only one component of regulatory controls imposed on 
medical devices intended to secure their safety and efficacy. 
What other controls are there, and what, if any, are the GAO's 
recommendations for the Food and Drug Administration to 
incorporate those if they haven't already done so.
    Ms. Crosse. Well, I think that the other key controls from 
our point of view are those postmarket controls, the ability of 
the agency to ask for further study, for additional data, for 
monitoring of the devices by the companies, and also the 
adverse event systems that FDA has. We have not pointed to 
legislative remedies being needed in this area. The kinds of 
problems that we have seen are ones that FDA currently has 
authority, but in some instances not resources to actually 
conduct, you know, the kinds of postmarket oversight as 
necessary.
    They have begun to take some good steps in that area. They 
have a Med Sun system that they have created where they have 
some additional surveillance, more active surveillance system 
ongoing. They haven't had the resources to be able to review 
all the reports that are coming in that are being generated by 
that system. So that kind of control, we think, would be 
important for them to be able to exercise to have a better 
understanding and, as was just stated, to be able to identify 
some of the problems that may be cropping up more quickly to be 
able to take actions more readily and to ensure that they are 
on top of whether companies are following through on the 
commitments that they have requested at the time that something 
is cleared or approved for marketing. So those kinds of 
controls.
    Mr. Burgess. Does that fit with, you know, your 
description? In a perfect world, the FDA would be the one that 
finds problems and alerts the health care committee to the 
problem. But the reporting system is such that after just a few 
adverse events, the FDA at least should develop some 
institutional curiosity as to investigate these.
    Dr. Maisel. Right, I mean I don't think the FDA should be 
the only one, and I think that Congress recognized that when 
they set up this system. We need people on the front lines 
reporting the adverse events and the device malfunctions. And 
for the most part, manufacturers actually do a really great job 
of taking their product and the reports of malfunctions and 
figuring out what goes wrong and fixing the devices and 
resubmitting 510(k) applications. That is what we want them to 
do.
    But it would be nice for the FDA to be able to take the 
200,000 device adverse event reports that they get and be able 
to sort through those and find a pattern of malfunction or 
devices that are going wrong with this large database they 
have. And there will be investments in information technology, 
and they are moving in that direction.
    Mr. Burgess. Well, I was just going to ask you. What is it 
that prevents that from happening today? Is it the IT 
architecture that is available?
    Dr. Maisel. I think that is a major component. The other 
component is that the quality of the data they get is suspect. 
An adverse event report could say patient had device implanted 
and died, and that could be the entire report. So a lot of 
times, they are spending time calling clinicians or trying to 
figure out what really happened. They might not even know the 
serial number of the device or the company that made the 
device. It is very difficult for them to connect the dots, and 
it is going to require significant investment.
    Mr. Burgess. Well, now you had a patient who had an 
implantable cardiac device and had an adverse event. Did you 
report that? How did you go about notifying the FDA that there 
was a problem, or was that problem already recognized so this 
was just one of many?
    Dr. Maisel. It was both. I mean the device had already been 
recalled. The patient had been informed that his device was 
recalled. We had had a discussion about the management options, 
and the lowest risk option for him was to leave the device in 
place. And unfortunately he had an adverse event. I reported it 
to the FDA via the Med Watch system, but for an outlier of all 
the adverse event reports reported to the FDA about over 95 
percent come from manufacturers. It is very rare that health 
care providers report adverse events. There is a little 
incentive for them to do it other than it is the right thing to 
do in the goodness of their heart. They don't get paid for it. 
It takes a considerable amount of time.
    Mr. Burgess. Would a provider limit future liability that 
they might incur if they went through the adverse reporting 
system, much like NASA has for the air traffic control system? 
There is a get out of jail free card if you report an adverse 
event in the nation's skyways. Do we have such a thing for 
adverse events?
    Dr. Maisel. No, and I am not really sure that that would 
have any impact on the reporting. I don't think physicians 
are--my sense is events aren't being reported because they are 
concerned about liability. They have, like you, a busy day, and 
there is 10 minutes of their day that they don't have to give 
away. They can go do something else, and no one is going to 
come after them. And they don't have to do it so it is not 
required.
    Mr. Burgess. Just one other observation on the AEDs because 
this has been important, and, yes, this committee has been 
involved. And I have been involved with my state legislators 
back home in Texas to get these devices at water parks and high 
school football games and what have you. And I will never 
forget a town hall meeting I had in South Lake, Texas one time 
when a man went into v-tac and v-fib sort of in the waiting 
area. And they fortunately had an AED, but it was locked up in 
the basement downstairs. So it really didn't do anyone any 
good. And I can tell this story because the paramedics arrived 
quickly, and the AED, in fact, saved his life.
    But after I got back up here to the capital, I began to 
look around. Where are our AEDs? I was informed that we had 
appropriated money and we had purchased the AEDs, and they were 
indeed locked up in a cabinet somewhere because we hadn't 
gotten permission from the architect of the Capitol to place 
the cabinets and we hadn't agreed on the type of cabinetry that 
should be placed in the historic buildings around the Capitol.
    So, you know, you can do all the right things and still be 
left with--at some point, the decision tree falls apart, and 
you don't get the information or the device into the hands of 
the people who need it.
    Dr. Maisel, based on your experience chairing the Food and 
Drug Administration's postmarket heart device advisory panel, 
on the panel, how long does it take you to review a device when 
it comes to your attention, when there is a report made?
    Dr. Maisel. The sponsor of the device in the FDA prepare a 
pretty remarkable panel pack that often runs into hundreds of 
pages that includes both the administrative record, our review 
of the bench testing and engineering, the clinical studies. And 
then we get it several weeks in advance, and, you know, it 
takes hours, you know, probably 10 hours or more to review. And 
then we usually have an eight-hour meeting to discuss the 
results.
    Mr. Burgess. So it is somewhat cumbersome and time 
consuming?
    Dr. Maisel. I guess it depends on your perspective.
    Mr. Burgess. Now, April this year, there were some Food and 
Drug Administration employees that sent a letter to the 
President saying that the device process was essentially 
broken. Now, is that a statement that you could find agreement 
with, or do you think that is an overreaction?
    Dr. Maisel. I don't know that I want to comment on what 
these individuals said because I don't know what their 
allegations were based on. I will say I think we are here today 
because we all feel that there are things that can be done 
better. I can say in working with literally hundreds of 
individuals at the FDA, I have yet to come across someone who I 
did not feel was trying to do the right thing for the American 
public.
    It is not like there are people walking around at the 
agency who are trying to circumvent the rules. I think they are 
trying to do the best they can with the resources that they are 
given.
    Mr. Burgess. So the motives are pure, but what about, then, 
the process itself? And what about the 510(k) process? And we 
have heard testimony that it may not even involve clinical 
testing in humans. It may be just simply bench testing, or it 
may be testing in laboratory animals.
    Dr. Maisel. I think, you know, I think Congress has done an 
amazing job of giving FDA a roadmap, a recipe book of what they 
are supposed to do for certain types of devices. But there is 
leeway in that roadmap. There is judgment that the FDA needs to 
apply to a given device in a given situation. And I think one 
of the problems is that judgment is applied inconsistently.
    And I think, for obvious reasons, we are focusing a lot on 
the 510(k), but I don't think we should completely ignore the 
PMA process. Yes, it represents only one percent of devices, 
but some of those individual devices go out to several million 
people. I mean there are tens of millions of people who get PMA 
devices. Four out of five PMA devices are approved via the PMA 
supplement pathway, not via the original PMA pathway. And the 
PMA supplement pathway, 80 percent of the PMAs approved is a 
much, much lower bar.
    A lot of those PMA supplements are 180-day PMA supplements, 
which is a class that Congress set up, and that doesn't 
necessarily require clinical data. The Sprint Fidelis lead that 
my patient had is a perfect example. That was approved via a 
PMA supplement, zero clinical data before this life-sustaining 
device goes into people.
    Mr. Burgess. Well, given that, and just speaking of the 
510(k) world for a moment, what changes to that process would 
you suggest? And are those changes within the purview of the 
FDA and within the tools that they have right now? Or is that 
going to require additional input from Congress?
    Dr. Maisel. I do believe that the FDA has most of the tools 
that they need. Whether they will use them and be applied is a 
different story, and so that is sometimes where Congress can 
obviously help and direct them to apply. I think that there 
needs to be better clarification of which type of 501(k) 
devices should have clinical data associated with them. I don't 
think it should be a case-by-case basis. I am a reviewer 
sitting at the FDA, and I am going to look at this device and 
make my best judgment.
    There need to be standards. There need to be guidance, I 
think from Congress, to the FDA about what you expect, what we 
expect to see for certain types of products. And it should be 
based on the risk of the product, and it should be based on the 
risk to patients. I think you could weigh in the effectiveness 
as well, as we spoke about. I mean for a product that is a 
life-sustaining product that is a really important product, I 
am willing to accept a different safety standard. I am willing 
to have less data if it is a really important product. And for 
products that are a me-too product, and we have other products 
that are just as helpful, I think the standards are different.
    But I think Congress can help by clarifying the standards 
for the FDA or at the very least, FDA needs to be more 
transparent about how they are going to apply their standards.
    Mr. Burgess. You may be overestimating the ability of 
Congress, but you can ask. I appreciate the acknowledgement. 
Let me ask you a question that is really not fair and it calls 
for rank speculation and you may regret----
    Dr. Maisel. I am good at that so----
    Mr. Burgess. Yeah, me too. You may regret that you stayed 
here all day, but we are faced now--this is an important issue 
that we are dealing with. And we need to get it right, and the 
fact that we have been here all day focusing on it indicates 
that there is a problem that we need to get right.
    Now, we are also in the process of looking at very complex 
biologic molecules, and I realize they are not devices. These 
are medications. The issue of follow-on biologics is coming up 
to our committee, and we are helping the FDA decide the best 
way to approach the assessment of so-called follow-on product.
    And it seems to me there are so many similarities here. I 
mean, although one is a device and one is a complex biologic 
molecule, we are talking about using a certification procedure 
that is somewhat abbreviated or at least has the flexibility to 
be somewhat shortened from what the normal procedure would be. 
In this case, in the biologics case, going through a new drug 
application. And in the device case, going through the full PMA 
rather than a 510(k) process.
    Is that an unfair analogy to draw between the issue of 
follow-on biologics and the issue that we are dealing with here 
today with the 510(k) process?
    Dr. Maisel. Well, I think you have described it well. I 
mean they do have components of both drugs and devices. I think 
the lesson would be we don't know a lot about them. There is a 
lot we still need to learn about biologics. And we need to have 
a total product life cycle. We can't just have a premarket 
evaluation and put them on the market and start having patients 
get them and then forget about them.
    At the same time, we don't want them to go into patients 
and just study them after they are into hundreds or thousands 
of patients. So I think that whatever program is established 
needs to carefully balance the benefit to patients or at least 
the potential benefit to patients so that we can get these 
important products out to them quickly, but at the same time 
study them. Require postmarket studies so that we can make sure 
that the products are doing what they are supposed to do and 
that patients are safe.
    Mr. Burgess. And the concept of the life cycle is one that 
is really extremely important because many of these devices are 
implanted in someone whose forward life expectancy may be two, 
three, or four decades. And is the device capable of holding up 
in conditions inside the human body over that time and 
particularly the artificial joint replacements that we have 
seen.
    And even getting into dental procedures. There can be 
analogous situations there. I really do appreciate you sharing 
that with us today. Mr. Chairman, I am going to ask that since 
Dr. Lurie, I guess, had to leave, and I had a set of questions 
that I wanted to pose to him. But can I do that in writing?
    Mr. Pallone. Absolutely, and I said to the panel that since 
a lot of the members didn't come back you should expect that 
you will get some written questions. Usually we ask the members 
to get them in within the next 10 days.
    Mr. Burgess. You can have them before I leave.
    Mr. Pallone. Well, we will, you know, open the record 
obviously for the written questions in light of--well, we 
always do anyway but particularly today because of the long 
day.
    Mr. Burgess. Let me just ask Mr. Phillips one final 
question because he has been so patient to sit here all day. 
Now, we have heard testimony, it seems like hours ago now, that 
only 10 to 15 percent of 501(k) submissions contain any 
clinical data, and you obviously have had some experience 
working at the FDA. Do you think that within the 501(k) 
approval process that there should be some clinical data 
available or some clinical trials performed?
    Mr. Phillips. I think without question the answer is yes 
because what we have seen is clearly over time evolution and 
technology changes. We talked about, Dr. Lurie talked about 
issues of intended use, and without question, when you start 
dealing with changes in intended use and changes in technology, 
invariably, there is going to be situations where you are going 
to have to have human experience.
    Mr. Burgess. And so you really answered the second part of 
that question. It should be human. It cannot be just bench 
testing or animal testing.
    Mr. Phillips. You know it is interesting because I, you 
know, through my career, I have hung out with a lot of 
engineers. And to a very large extent, you find that you can 
get a lot of precise information regarding engineering 
analysis. We talked about, for example, the breakage of a lead. 
There is a lot that you can do to characterize the strength and 
integrity of a lead.
    I think that, you know, for premarket evaluation, there has 
to be a balance that is struck. And I think that we talk about 
the total product life cycle, and I think from an FDA 
regulatory perspective, they have to have the controls in place 
to provide adequate assurance, reasonable assurance of safety 
and effectiveness in the short term. But I think there needs to 
be postmarket controls so that you can monitor in a very 
vigilant way performance once products get to market.
    I think that there are many situations where it is 
perfectly reasonable to allow a product to go to market based 
upon preclinical engingeering analysis and data. But in order 
to do that, you have to have high confidence that you have 
mechanisms in place that are going to be able to pick up 
problems once products are out and available in a much larger 
population.
    You know clinical trials with medical devices, a large 
clinical trial is 200 to 300 patients for a medical device. And 
clearly there is a limit as to how much you can even detect in 
a relatively small patient population. And keep in mind the 
duration of trials, a long trial is a two-year trial for a 
medical device. And many of these products, as you just 
indicated, are going to be placed into individuals for very 
lengthy periods of time, perhaps the rest of their life.
    So I think that there has to be a focus on trying to figure 
out what the proper premarket, postmarket balance is so that we 
don't develop a system which really becomes a deterrent to 
industry, innovating and developing new technologies but gives 
the American public the confidence that once products are made 
available, that there are mechanisms in place to pick up any 
kind of events that represent, you know, something of 
significance that they need to know about or other clinicians 
need to know about.
    Mr. Burgess. Well, Dr. Lurie also referenced a compound 
that was used for articular surfaces and the fact that this was 
a weight-bearing structure made a difference as well. So 
something like that where there is a long length of time for 
intended use in someone's body. And there is a special 
situation that this is a weight-bearing structure. It seems to 
me, and I think obviously I am no expert, but it seems to me 
that this is one of those situations that would not lend itself 
to a facilitated or abbreviated process but one where you would 
want to have the availability of all the data possible and then 
the longitudinal studies since again we are talking about 
something that exists over--is intended to be used over a long 
period of time, longitudinal studies become very important as 
well. Would you not agree with that?
    Mr. Phillips. Well, I would agree with that in concept, but 
let me also disclose that the example that Dr. Lurie was 
addressing in his remarks this morning, I am an actual 
consultant for that company. So I want to make sure that 
everybody is aware that there is that relationship.
    But, you know, it is interesting because I think that you 
need to look at the body of evidence that was provided on that 
particular device as well. It was a 510(k) clearance, but there 
was a tremendous amount of data, in fact a lot more data in 
that submission than what is in the vast majority of 501(k) 
applications.
    There can be a lot of discussion as to the quality of the 
data, what that data established, but I think for all practical 
purposes, the intended use of that device was well corroborated 
with the data that was included in this submission.
    I understand that Dr. Hamburg and Dr. Sharpstein are 
looking into that issue right now, and interested to find out 
what their assessment is.
    Mr. Burgess. Well, Mr. Chairman, I will just come back to 
where I started this morning. It begs the question where is the 
FDA. So I hope we will have a follow-up hearing at some point, 
and I know the calendar is condensed and compressed. And we are 
all pressed for time, but it is hard to have this type of 
hearing on this type of evaluation and evaluating rather the 
process the FDA uses without having the FDA here to weigh in on 
it.
    And, Dr. Maisel, let me just say too I am so grateful you 
are here. And we have heard so much from the science board on 
the FDA that yeah, we need to fund. They do need more money, 
but the procedures and the policies are things that need to be 
looked at as well.
    And then, of course, in the brave new world of the FDA 
regulating tobacco, and I don't know how you ever decide that 
it is--you can decide that it is effective, but I don't know 
how you ever decide that it is safe. And they have a mission 
that is--we have given them a mission that is virtually 
impossible for them to perform.
    But really appreciate all the witnesses being here today 
and staying with us so long. I will yield back to the chairman.
    Mr. Pallone. Thank you, Dr. Burgess. Again thanks, you 
know, for your patience, but I am glad that you came back and 
we were able to ask the questions that we did ask today. We 
will have some more written questions, but thanks again. Have a 
good and safe trip home. And without further ado, the 
subcommittee hearing is adjourned.
    [Whereupon, at 7:35 p.m., the Subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]








