[Senate Hearing 112-878]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 112-878
 
                 MEDICAL DEVICES: PROTECTING PATIENTS 
                        AND PROMOTING INNOVATION 

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

                                   ON

    EXAMINING MEDICAL DEVICES, FOCUSING ON PROTECTING PATIENTS AND 
                          PROMOTING INNOVATION

                               __________

                           NOVEMBER 15, 2011

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


      Available via the World Wide Web: http://www.gpo.gov/fdsys/


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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                       TOM HARKIN, Iowa, Chairman

BARBARA A. MIKULSKI, Maryland              MICHAEL B. ENZI, Wyoming
JEFF BINGAMAN, New Mexico                  LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington                   RICHARD BURR, North Carolina
BERNARD SANDERS (I), Vermont               JOHNNY ISAKSON, Georgia
ROBERT P. CASEY, JR., Pennsylvania         RAND PAUL, Kentucky
KAY R. HAGAN, North Carolina               ORRIN G. HATCH, Utah
JEFF MERKLEY, Oregon                       JOHN McCAIN, Arizona
AL FRANKEN, Minnesota                      PAT ROBERTS, Kansas
MICHAEL F. BENNET, Colorado                LISA MURKOWSKI, Alaska
SHELDON WHITEHOUSE, Rhode Island           MARK KIRK, Illinois
RICHARD BLUMENTHAL, Connecticut
                                       

                    Daniel E. Smith, Staff Director

                  Pamela Smith, Deputy Staff Director

     Frank Macchiarola, Republican Staff Director and Chief Counsel

                                  (ii)



                            C O N T E N T S

                               __________

                               STATEMENTS

                       TUESDAY, NOVEMBER 15, 2011

                                                                   Page

                           Committee Members

Harkin, Hon. Tom, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina.......................................................    15
Franken, Hon. Al, a U.S. Senator from the State of Minnesota.....    18
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of 
  Pennsylvania...................................................    19
Bennet, Hon. Michael F., a U.S. Senator from the State of 
  Colorado.......................................................    21
Mikulski, Hon. Barbara A., a U.S. Senator from the State of 
  Maryland.......................................................    24
Blumenthal, Hon. Richard, a U.S. Senator from the State of 
  Connecticut....................................................    26
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah......    30
Hagan, Hon. Kay R., a U.S. Senator from the State of North 
  Carolina.......................................................    32

                            Witness--Panel I

Shuren, Jeffrey, M.D., J.D., Director of the Center for Devices 
  and Radiological Health, Food and Drug Administration, Silver 
  Spring, MD.....................................................     3
    Prepared statement...........................................     5

                          Witnesses--Panel II

Hall, Ralph F., B.A., J.D., Professor of Practice, University of 
  Minnesota Law School, Minneapolis, MN..........................    36
    Prepared statement...........................................    38
Challoner, David R., M.D., Vice President for Health Affairs, 
  Emeritus, University of Florida and Chair, Committee on the 
  Public Health Effectiveness of the FDA 510(K) Clearance 
  Process, Institute of Medicine of the National Academies, 
  Gainesville, FL................................................    51
    Prepared statement...........................................    52
Curfman, Gregory D., M.D., Executive Editor, New England Journal 
  of Medicine, Boston, MA........................................    54
    Prepared statement...........................................    56

                          ADDITIONAL MATERIAL

Response to questions of Senator Bennet by David R. Challoner, 
  M.D............................................................    70

                                 (iii)

  


     MEDICAL DEVICES: PROTECTING PATIENTS AND PROMOTING INNOVATION

                              ----------                              


                       TUESDAY, NOVEMBER 15, 2011

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 2:34 p.m. in Room 
SD-G50, Dirksen Senate Office Building, Hon. Tom Harkin, 
chairman of the committee, presiding.
    Present: Senators Harkin, Franken, Merkley, Casey, Bennet, 
Mikulski, Blumenthal, Hagan, Hatch, and Burr.

                  Opening Statement of Senator Harkin

    The Chairman. Good afternoon. The Senate Committee on 
Health, Education, Labor, and Pensions will come to order. This 
is the third hearing we have convened as part of our ongoing 
process to authorize the FDA user fee legislation. Today we 
examine the FDA's regulation of medical devices.
    As the sponsor of the American's Disabilities Act, now 21 
years old, I recognize that these devices often enable 
individuals to live their lives to the fullest. It's hard to 
imagine modern medicine functioning without them, and countless 
patients who have had their lives changed for the better by 
medical devices. Accordingly, it is essential that we encourage 
the continued development and improvement of medical devices, 
and that efficient regulatory processes get these innovative 
devices to patients as quickly as possible. However, there is 
no virtue in getting devices to patients quickly if the devices 
don't work or, worse, if they cause injury or death.
    I think most Americans would be alarmed if they understood 
the current process we use to approve most medical devices. 
People probably imagine that for every moderate or high-risk 
device--certainly anything that's implantable in the human 
body--that experts at FDA examine clinical data, and conclude 
that the device has been demonstrated to be safe and effective. 
But that's not what happens. Most devices are cleared by FDA 
through a process in which a device must merely show to be 
``substantially equivalent'' to another device that's already 
on the market, even if that device was substantially equivalent 
to a previous device, and that previous device was 
substantially equivalent to a previous device--and on and on 
and on and on.
    This process gets devices to patients more quickly, but 
sometimes with catastrophic consequences for patients. 
Recently, for example, all-metal hip implants were cleared 
through the 510(k) process, in many cases without clinical 
data. As it turns out, when the metal ball rubs against the 
metal socket, tiny metal particles can wear off, cause damage 
to the bone and tissues surrounding the implant, and the metal 
ions can get into the bloodstream and cause problems in the 
heart, nervous system and thyroid gland. Today, there are 
around a half a million Americans walking around with a 
dangerous hip implant, and no great options. Do they have 
surgery to have implant removed, or keep it and risk becoming 
another victim of the rush to get these products to market?
    There's been a great deal of talk lately about promoting 
innovation, and I'm all for that, especially when innovation 
leads to the creation of jobs and even entirely new industries. 
But promoting innovation doesn't just mean, willy nilly, 
getting products to market so that device companies can make a 
profit. In a recent article, one of our witnesses today, Dr. 
Gregory Curfman, made the point that true innovation is not 
just the matter of getting products to market quickly, but also 
of ensuring that they are safe and effective. A device is only 
a worthy innovation if it works, and it doesn't hurt people. 
Speeding medical devices to market without adequate data and 
testing might be good for business in the short-term. It might 
even create some jobs in the short-term. But if the device is 
faulty, patients will pay the price, business will be hurt, and 
those jobs will disappear. As Dr. Curfman noted in his article, 
and I quote: ``Our regulators should not be in the business of 
creating jobs in the manufacture of dangerous devices.'' That 
is not a good business model at all. I want to do everything 
possible to help U.S. manufacturers to create innovative and 
safe devices, and get them to market as expeditiously as 
possible. To that end, the FDA must strike the appropriate 
regulatory balance.
    At a minimum, FDA should reserve its streamlined 510(k) 
process for devices that are truly of moderate risk. Any high-
risk device should be required to submit a premarket approval 
application. Over 20 years ago, in the Safe Medical Devices Act 
of 1990, Congress made it clear that FDA should use its 
premarket approval process for high-risk class III devices, or 
it should reclassify them to a lower-risk category. Despite 
this direction from Congress, high-risk devices continue to 
slip by this requirement.
    If we're going to retain a system in which devices can be 
cleared based on substantial equivalence to predicate devices, 
we need to create assurance that the predicate device is safe, 
and works. We need to follow cleared devices throughout their 
lifecycle so that we know how they perform in the real world. 
That way, when a follow-on device seeks approval based on a 
predicate, we know something about how that predicate worked, 
and we will be more confident that ``substantial equivalence'' 
tells us something about safety and effectiveness. Certainly, 
if a device turns out to be dangerous, if it's withdrawn or 
recalled for safety reasons, it is absurd to continue to allow 
that dangerous device to be used as a predicate for later 
products.
    So, I intend to work with FDA and my colleagues on this 
committee to strengthen and improve FDA's postmarket 
authorities, so that we all can have more confidence in the 
510(k) system's ability to ensure patient safety.
    This afternoon, we'll hear from several expert witnesses 
who approach this important issue from a variety of 
perspectives. I thank you all for being here, and I look 
forward to your remarks.
    We have two panels. On panel one we have just one witness, 
Dr. Jeffrey Shuren, who is the Director of the FDA Center for 
Devices and Radiological Health.
    Dr. Shuren became the Director in January 2010. He 
previously served as Acting Center Director beginning in 
September 2009. Dr. Shuren is both a medical doctor and a 
lawyer, having earned his medical degree at Northwestern 
University, and his law degree at the University of Michigan.
    He has had a long and distinguished career at FDA. He's 
held a variety of policy positions at the agency, including 
Acting Deputy Commissioner for Policy Planning and Budget, 
Associate Commissioner for Policy and Planning, Special Counsel 
to the Principal Deputy Commissioner, Assistant Commissioner 
for Policy, and a Medical Officer in the Office of Policy.
    In the last 18 months, he's led FDA's effort to improve 
both the performance of the Center for Devices for Radiological 
Health, and the 510(k) review system. We're pleased to have him 
here today. We welcome you here, Dr. Shuren. And without 
objection, your full statement will be made a part of the 
record. And if you could sum it up in, oh, 5, 7 minutes, or 
so--we'd certainly appreciate it.
    Dr. Shuren, please proceed.

STATEMENT OF JEFFREY SHUREN, M.D., J.D., DIRECTOR OF THE CENTER 
      FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG 
               ADMINISTRATION, SILVER SPRING, MD

    Dr. Shuren. Thank you, Mr. Chairman and members of the 
committee.
    As mentioned, I am Dr. Jeff Shuren, Director of the Center 
for Devices and Radiological Health at the Food and Drug 
Administration. Thank you for the opportunity to testify today.
    In late 2009, and soon after I came to CDRH, The Center for 
Devices and Radiological Health, we initiated a review of our 
medical device premarket programs in response to concerns 
expressed by industry and others. We conducted an honest and 
frank self-assessment to these processes, including the 510(k) 
program.
    As part of that process, CDRH has begun to undertake a new, 
more systematic approach to device regulation--one that 
continues to focus on protecting public health by assuring that 
devices are safe and effective, but also focuses on promoting 
public health by facilitating device innovation. In fact, last 
year, innovation became one of our top four strategic 
priorities.
    This new approach required that we move away from the 
traditional misperception that safety, effectiveness and 
innovation are incompatible. Rather than focus on more 
regulation or less regulation, we began to focus on smart 
regulation--how to most effectively achieve both aspects of our 
mission as both a regulator and a facilitator.
    We realized that FDA should help to create a regulatory 
environment that allows innovation to thrive by eliminating 
undue regulatory obstacles, while also ensuring consumer 
confidence that our medical technologies are safe and 
effective.
    In 2010, we released two reports that concluded we at FDA 
had not done as good a job managing our premarket programs as 
we could have. The No. 1 problem we found was insufficient 
predictability which can lead to inefficiencies, increased cost 
for industry and the FDA, and sometimes in delays in bringing 
safe and effective products to market.
    These circumstances may also create challenges for smaller 
startup companies in securing venture capital funding for new 
early stage technologies.
    We identified several root causes of these problems, and 
they include very high reviewer and manager turnover at CDRH--
which is almost double that of our Center for Drugs and our 
Center for Biologics, insufficient reviewer training, extremely 
high ratios of front-line supervisors to reviewers, 
insufficient oversight by managers, a rapidly growing workload 
caused by increase in complexity of devices, and the rapidly 
increasing overall number of submissions we receive, sometimes 
unnecessary or inconsistent data requirements imposed on device 
companies, insufficient guidance for industry and FDA staff, 
and poor quality of submissions from industry.
    We identified proposed solutions to these problems, and 
after extensive public input last January, we announced a plan 
of action detailing 25 specific actions that CDRH would take in 
2011 to improve the predictability, consistency and 
transparency of our premarket programs, and since then, we've 
announced additional efforts.
    The actions we are taking fall into three main areas of 
emphasis: first, we must create a culture change toward greater 
transparency, interaction, collaboration and the appropriate 
balancing of benefits and risks; second, we need to focus on 
ensuring predictable and consistent recommendations, 
decisionmaking and application of the least burdensome 
principal; and third, we need to take steps to implement more 
efficient regulatory processes, and user resources.
    Last month, we reviewed the progress we've made thus far, 
and issued a 26-page report summarizing many of the concrete 
actions that have already been implemented or will be 
implemented, at least in part, in the first half of 2012.
    We believe that these actions will have a visible positive 
impact within the coming year by providing greater 
predictability about data requirements through guidance, 
reducing unnecessary or inconsistent data requests through 
training, and policy and process changes, implementing policies 
that lead to appropriately balanced benefit-risk determinations 
using external experts more extensively and effectively, 
creating incentives to create clinical studies first in the 
United States, speeding up clinical trial approval decisions, 
and implementing the innovation pathway.
    We understand that in order to best serve patients, both 
the medical device industry and FDA must have the flexibility 
to be innovative, to be entrepreneurial, and ultimately 
successful.
    For this to happen, three things must occur. We must 
continue to make the critical improvements to our device 
program that we described in last month's report. Just as 
important, CDRH and industry must work together to assure that 
the Center receives high quality premarket submissions. And 
finally, CDRH must have adequate and stable resources to get 
the job done right, and as quickly as possible. This is the 
subject of the upcoming user fee reauthorization.
    We at CDRH believe that if these three things are 
accomplished, we will provide the kind of value that patients 
deserve and come to expect from FDA. Timely access to safe and 
effective devices that address their healthcare needs, and the 
medical device industry will have the kind of predictable, 
consistent, transparent and efficient pathways to market that 
spur continued innovation and success.
    Mr. Chairman, I commend the committee's efforts, and I'm 
pleased to answer any questions the committee may have.
    [The prepared statement of Dr. Shuren follows:]
            Prepared Statement of Jeffrey Shuren, M.D., J.D.
                              introduction
    Mr. Chairman and members of the committee, I am Dr. Jeffrey Shuren, 
director of the Center for Devices and Radiological Health (CDRH) at 
the Food and Drug Administration (FDA or the Agency). I am pleased to 
be here today to discuss CDRH's premarket review process and the 
activities that we are undertaking to improve the predictability, 
consistency, and transparency of our regulatory processes.
The Impact of Regulation on Device Innovation
    FDA is charged with a significant task: to protect and promote the 
health of the American public. To succeed in that mission, we must 
ensure the safety and effectiveness of the medical products that 
Americans rely on every day, and also facilitate the scientific 
innovations that have the potential to save patients' lives. Our 
ability to work with innovators to translate discoveries into safe and 
effective products that can be cleared or approved in a timely way is 
essential to public heath, as well as the growth of the medical 
products industry and the jobs it creates. Importantly, FDA's premarket 
review of medical devices gives manufacturers a worldwide base of 
consumer confidence, both domestically and internationally.
    U.S.-based companies dominate the roughly $350 billion global 
medical device industry. The U.S.-medical device industry is one of the 
few sectors, in these challenging economic times, with a positive trade 
balance.\1\ In 2000, the U.S.-medical device industry ranked 13th in 
venture capital investment--now, a decade later, it's our country's 
fourth largest sector for venture capital investment.\2\ In fact, more 
than 62 percent of the $631.4 million that venture capital invested in 
the life sciences in the third quarter of 2011 went to medical device 
companies.\3\ And, the medical device industry has produced a net gain 
in jobs since 2005, even while overall manufacturing employment has 
suffered.
---------------------------------------------------------------------------
    \1\ PwC (formerly PriceWaterhouseCoopers), ``Medical Technology 
Innovation Scorecard'' (January 2011) at page 8, available at http://
pwchealth.com/cgi-local/hregister.cgi?link=reg/innovation-
scorecard.pdf.
    \2\ PriceWaterhouseCoopers/National Venture Capital Association, 
MoneyTreeTM Report, Data: Thomson Reuters, Investments by Industry Ql 
1995-Q4 2010, available at http://www.nvca.org.
    \3\ ``Medical Device Developers Attract Cash: Venture Capital 
Increases Its Funding of Medical Technology,'' The Burrill Report (Oct. 
14, 2011), available at http://www.burrillreport.com/article-
medical_device_developers_attract_cash.html.
---------------------------------------------------------------------------
    As noted in a January 2011 report on medical technology innovation 
by PwC (formerly PriceWaterhouseCoopers), the U.S.-regulatory system 
and U.S.-regulatory standard have served American industry and patients 
well. As that report states,

          ``U.S. success in medical technology during recent decades 
        stems partially from global leadership of the U.S. Food and 
        Drug Administration. FDA's standards and guidelines to ensure 
        safety and efficacy have instilled confidence worldwide in the 
        industry's products. Other countries' regulators often wait to 
        see FDA's position before acting on medical technology 
        applications and often model their own regulatory approach on 
        FDA's.'' \4\
---------------------------------------------------------------------------
    \4\ PwC (formerly PriceWaterhouseCoopers), ``Medical Technology 
Innovation Scorecard'' (January 2011), available at http://
pwchealth.com/cgi-local/hregister.cgi?link=reg/innnovation-
scorecard.pdf.

    In terms of time to market, an industry-sponsored analysis \5\ 
shows that low-risk 510(k) devices without clinical data (80 percent of 
all devices reviewed each year) came on the market first in the United 
States as often as, or more often than, in the European Union (EU). The 
EU typically approves higher-risk devices faster than the United States 
because in the EU, manufacturers must demonstrate safety and 
performance, while in the United States the standard for approval is 
safety and effectiveness.\6\
---------------------------------------------------------------------------
    \5\ California Healthcare Institute and The Boston Consulting 
Group, ''Competitiveness and Regulation: The FDA and the Future of 
America's Biomedical Industry'' (Feb. 2011 ), available at http://
www.bdg.com/documents/file72060.pdf.
    \6\ See ``Recast of the Medical Devices Directives: Public 
Consultation,'' available at http://ec.europa.eu/consumers/sectors/
medical-devices/files/recast_docs_2008/public_consultation
_en.pdf; European Commission, ``Guidelines on Medical Devices: Clinical 
Evaluation: A Guide for Manufacturers and Notified Bodies'' (Dec. 
2009), at p. 4, available at http://ec.europa.eu/health/medical-
devices/files/meddev/2_7_Irev_3_en.pdf.
---------------------------------------------------------------------------
    FDA has been meeting or exceeding goals agreed to by FDA and 
industry under the Medical Device User Fee Amendments (MDUFA) for 
approximately 95 percent of the submissions we review each year. FDA 
completes at least 90 percent of 510(k) reviews within 90 days or less. 
In the few areas where FDA is not yet meeting its MDUFA goals, the 
Agency's performance has generally been improving--despite growing 
device complexity and an increased workload--without a commensurate 
increase in user fees.
    However, average total days for the review of 510(k)s has been 
increasing since 2005 (as described later in this testimony), and has 
been increasing for Premarket Approval (PMA) applications since 2004, 
with early indicators of longer review times, such as the average 
number of cycles to review a 510(k), starting to increase since 2002.
    FDA recognizes that, if the United States is to maintain its 
leadership role in this area, we must continue to streamline and 
modernize our processes and procedures to make device approval not just 
scientifically rigorous, but clear, consistent, and predictable without 
compromising safety.
Smart Regulation's Role in Facilitating Medical Device Innovation
    Nearly 2 years ago, CDRH recognized that, given the growing 
complexities of medical product development, we needed to re-evaluate 
and modernize our regulatory review processes in order to ensure that 
patients had timely access to safe and effective medical devices. At 
that time, CDRH began to undertake a new systematic approach to device 
regulation, moving away from the traditional misperception that safety 
and effectiveness and innovation are incompatible. Rather than focus on 
more regulation or less regulation, we began to focus on ``smart 
regulation.''
    Our goal has been to ensure that safety and effectiveness and 
innovation are complementary, mutually supporting aspects of our 
mission to promote the public health. As part of our process to improve 
CDRH's internal systems, we first reached out to stakeholders to hear 
their concerns and listen to their recommendations about our premarket 
programs. This is what we heard: industry felt that inadequate 
predictability, consistency, and transparency were stifling innovation 
and driving jobs overseas; and consumer groups, third-party payers, and 
some health care professionals believed that one of our premarket 
pathways--the 510(k) program--did not provide adequate protection for 
American patients and did not generate 
sufficient information for practitioners and patients to make well-
informed 
treatment and diagnostic decisions. In turn, CDRH employees expressed 
concerns that the 510(k) program had not adapted to the increasing 
complexity of devices, and that poor-quality 510(k) submissions, poor-
quality clinical studies conducted in support of PMA applications, and 
an ever-growing workload were straining already overburdened premarket 
programs.
    We also began two assessments of our premarket programs to identify 
issues, their root causes, and the appropriate solutions. One 
assessment focuses on the 510(k) program. The other looks at how we use 
science in regulatory decisionmaking, touching on aspects of several of 
our premarket review pathways, such as our clinical trials program. In 
addition, we contracted with the Institute of Medicine (IOM) to conduct 
an independent evaluation of our 510(k) program.
    In August 2010, following extensive public input, we released two 
reports that identified issues regarding our premarket programs and 
proposed potential actions for us to take to address the underlying 
root causes. The No. 1 problem we found was insufficient predictability 
in our premarket programs, which can create inefficiencies, increase 
costs for industry and FDA, and delay bringing safe and effective 
products to market. We identified several root causes of these issues. 
They include very high reviewer and manager turnover at CDRH (almost 
double that of FDA's drug and biologics centers); insufficient training 
for staff and industry; extremely high ratios of employees to front-
line supervisors; insufficient oversight by managers; CDRH's rapidly 
growing workload, caused by the increasing complexity of devices and 
the number of overall submissions we review; unnecessary and/or 
inconsistent data requirements imposed on device sponsors; insufficient 
guidance for industry and FDA staff; and poor-quality submissions from 
industry.
    While it is true that providing more user-fee resources alone won't 
solve the problems with our premarket programs, insufficient funding is 
at the root of, or a contributing factor to several of these problems. 
Adequate and stable funding is one key component to our and industry's 
success in bringing safe and effective devices to market quickly and 
efficiently.
    After considering extensive and varied public input on our 
recommendations, in January 2011, FDA announced a Plan of Action that 
included 25 specific actions that we would take this year to improve 
the predictability, consistency, and transparency of our premarket 
programs. The following month, we announced our Innovation Initiative, 
which included several proposals to help maintain the position of the 
United States as the world's leader in medical device innovation, 
including the creation of a new approach for important, new 
technologies called the Innovation Pathway.
    Since then, we have announced additional efforts to improve our 
premarket programs, including actions to improve our program for 
clinical trials and the Investigational Device Exemption (IDE) program. 
The actions we are taking can be grouped into three main areas of 
emphasis. Overall, our actions seek to:

     Create a culture change toward greater transparency, 
interaction, collaboration, and the appropriate balancing of benefits 
and risks;
     Ensure more predictable and consistent recommendations, 
decisionmaking, and application of the least-burdensome principle; and
     Implement more efficient processes and use of resources.

    Specific steps that we are taking include:

     Issuing guidance clarifying the criteria used to make 
benefit-risk determinations a part of device premarket decisions. This 
will provide greater predictability and consistency and apply a more 
patient-centric approach by considering patients' tolerance for risk in 
appropriate cases (draft guidance issued August 15, 2011);
     Creating standard operating procedures for when a reviewer 
can request additional information regarding a premarket submission and 
identifying at what management level the decision must be made. These 
steps are intended to provide greater predictability, consistency, and 
the appropriate application of the least-burdensome principle by 
reducing the number of inappropriate information requests (Standard 
Operating Procedures issued November 10, 2011);
     Developing a range of updated and new guidances to clarify 
CDRH requirements for predictable, timely, and consistent product 
review, including device-
specific guidance in several areas such as mobile applications (draft 
guidance released July 19, 2011) and artificial pancreas systems (to be 
completed by the end of 2011);
     Revamping the guidance development process through a new 
tracking system, streamlined processes, and, to the greatest extent 
possible within available resources, core staff to oversee the timely 
drafting and clearance of documents (to be completed by the end of 
2011);
     Improving communication between FDA and industry through 
enhancements to interactive review (some of these enhancements will be 
in place by the end of 2011);
     Streamlining the clinical trial (IDE) processes by 
providing industry with guidance to clarify the criteria for approving 
clinical trials, and the criteria for when a first-in-human study can 
be conducted earlier during device development. These actions aim to 
create incentives to bring new technologies to the United States first 
(guidances issued November 10, 2011) (IDEs are required before device 
testing in humans that involve significant risks may begin, and they 
ensure that the rights of human subjects are protected while gathering 
data on the safety and efficacy of medical products);
     Implementing internal business process improvements to 
ensure that decisions are made by the appropriate level of management, 
that decisions are made consistently and efficiently, and that we 
appropriately apply the least-burdensome principle. For example, CDRH 
created the internal Center Science Council to actively monitor the 
quality and performance of the Center's scientific programs and ensure 
consistency and predictability in CDRH scientific decisionmaking 
(Center Science Council established March 31, 2011);
     Creating a network of experts to help the Center resolve 
complex scientific issues, which will ultimately result in more timely 
reviews. This network will be especially helpful as FDA confronts new 
technologies (Standard Operating Procedures issued September 30, 2011);
     Instituting a mandatory Reviewer Certification Program for 
new reviewers (program launched September 2011);
     Instituting a pilot Experiential Learning Program to 
provide review staff with real-world training experiences as they 
participate in visits to manufacturers, research, and health care 
facilities, and academia (to begin in early 2012);
     Providing industry with specific guidance on how to ensure 
the quality and performance of clinical trials while applying the 
least-burdensome principle, so that industry conducts studies that are 
more likely to support the approval of their products (guidance 
released August 15, 2011); and
     Streamlining the de novo review process, the pathway by 
which novel, lower-risk devices without a predicate can come to market 
(draft guidance released October 3, 2011).

    To best serve patients, both the medical device industry and FDA 
must have the flexibility to be innovative and entrepreneurial. First, 
CDRH must continue making critical improvements to our device program. 
Second, the medical device industry and CDRH must work together to 
ensure that the Center receives high-quality submissions, which contain 
the information we need to make well-informed and timely decisions. 
Finally, CDRH must have adequate and stable resources to get the job 
done right and quickly. The latter is the subject of medical device 
user-fee legislation reauthorization and congressional appropriations.
    We believe that the actions we are taking now will have a positive 
impact within the coming year by providing greater predictability of 
data requirements through guidance, reducing unnecessary data requests 
through training and policy and process changes, implementing policies 
to appropriately balance benefit-risk determinations, using external 
experts more extensively, creating incentives to conduct clinical 
studies first in the United States, speeding up IDE approval decisions, 
implementing the Innovation Pathway 2.0 (a priority review program to 
expedite development, assessment, and review of important 
technologies), and instituting efficiencies in the premarket review 
process.
Performance Issues in the Premarket Review Process
    As noted above, FDA has been meeting or exceeding goals agreed to 
by FDA and industry under MDUFA for approximately 95 percent of the 
submissions we review each year. FDA completes at least 90 percent of 
510(k) reviews within 90 days or less. In the few areas where FDA is 
not yet meeting its MDUFA goals, the Agency's performance has generally 
been improving--despite growing device complexity and an increased 
workload--without a commensurate increase in user fees.
    However, MDUFA metrics reflect FDA time only; they do not reflect 
the time taken by device sponsors to respond to requests for additional 
information. As the graphs below illustrate, while the time FDA spends 
reviewing an application has improved (for both low- and high-risk 
devices), overall time to decision--the time that FDA has the 
application, plus the time the manufacturer spends answering any 
questions FDA may have--has increased steadily since 2001.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    FDA bears some responsibility for the increase in total time to 
decision, and we have been instituting management, policy, and process 
changes to address this issue. As a result, in 2011, CDRH for the first 
time began reducing what previously was an increasing backlog of 
unresolved 510(k) submissions.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    There has also been a prolonged increase, since fiscal year 2002, 
in the percentage of 510(k) submissions requiring an Additional 
Information (AI) letter after the first review cycle. The increasing 
number of AI letters has contributed to the increasing total time from 
submission to decision.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Submission quality problems are a driving force in this increase 
and we are pleased that, in response to FDA calls for improving the 
quality of premarket submissions, the medical device industry trade 
association, AdvaMed, is improving and making available more training 
courses for its companies to help them develop 510(k) and PMA 
submissions that meet FDA standards.
    We believe that the actions we are taking now will have a positive 
impact within the coming year by providing greater predictability of 
data requirements through guidance, reducing unnecessary data requests 
through training and policy and process changes, implementing policies 
to appropriately balance benefit-risk determinations, using external 
experts more extensively, creating incentives to conduct clinical 
studies first in the United States, speeding up IDE approval decisions, 
implementing the Innovation Pathway 2.0 (a priority review program to 
expedite development, assessment, and review of important 
technologies), and instituting efficiencies in the premarket review 
process.
Moving Forward: Reauthorization of MDUFA
    When MDUFA was last reauthorized in 2007, Congress directed FDA to 
take additional steps to ensure that public stakeholders would have 
adequate opportunity to provide input to any program enhancements. In 
addition to FDA receiving input from stakeholders during an initial 
public meeting in September 2010, Congress directed the Agency to meet 
with public stakeholders every month while conducting negotiations with 
regulated industry to hold discussions on their views about the 
reauthorization and hear their suggestions for changes to the MDUFA 
performance goals. We have been meeting with stakeholders, including 
representatives of patient and consumer groups, since January 2011.
    Since last January, we also have been holding discussions with 
regulated industry in an effort to develop a package of proposed 
recommendations for MDUFA reauthorization. Upon completion of these 
negotiations and discussions, the public will have an opportunity to 
comment on these proposals prior to our submission of final MDUFA 
recommendations to Congress.
    As the MDUFA reauthorization process moves forward, it is important 
to understand and keep in mind the significant differences between 
FDA's medical device premarket review programs--the 510(k) and PMA 
programs--and the Agency's program for review of drugs under the 
Prescription Drug User Fee Act (PDUFA). PDUFA fees account for about 
two-thirds of the drug review program's budget--nearly $568 million in 
fiscal year 2010--while user fees under MDUFA fund only about 20 
percent of the device review program.
    The structures of the user fee programs also differ in very 
significant ways. The fee for fiscal year 2012 associated with review 
of a New Drug Application (NDA) requiring clinical data is $1,841,500 
\7\--much greater than the $220,500 fee \8\ charged for review in 
fiscal year 2012 of a PMA for high-risk medical devices (a business 
with gross receipts under $30 million qualifies for the ``small 
business'' PMA fee of about $55,000--75 percent less than the full 
fee). For lower-risk devices cleared under the 510(k) review program, 
the fees are even lower: $4,049 per 510(k) application review ($2,024 
for small businesses).
---------------------------------------------------------------------------
    \7\ See U.S. FDA, ``Prescription Drug User Fee Rates for Fiscal 
Year 2012,'' 76 Fed. Reg. 45,831-45,838 (Aug. 1, 2011), available at 
http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/pdf/2011-19332.pdf.
    \8\ See U.S. FDA. ``Medical Device User Fee Rates for Fiscal Year 
2012,'' 76 Fed. Reg. 45,826-45,831 (Aug. 11, 2011), available at http:/
/www.gpo.gov/fdsys/pkg/FR-2011-08-01/html/2011-19335.htm.
---------------------------------------------------------------------------
    While we work with industry toward a reauthorization of medical 
device user fees in order to provide adequate and stable funding for 
the program, we also continue to move forward on CDRH program 
improvements, with a focus on smart regulation. As these new policies 
and processes continue to be implemented, we expect to see notable 
improvements in the consistency, transparency, and predictability of 
our premarket review programs.
Smart Regulation's Role in Assuring Patient Safety
    As we continue to look for ways to improve our ability to 
facilitate innovation and to speed safe and effective products to 
patients, we must not lose sight of the benefits of smart regulation to 
the medical device industry, to patients, and to society. Smart 
regulation of medical devices results in better, safer, more effective 
treatments as well as worldwide confidence in, and adoption of, the 
devices that industry produces.
    We at FDA see daily the kinds of problems that occur with medical 
devices that are poorly designed or manufactured, difficult to use, 
and/or insufficiently tested. We appreciate the concern that some 
devices come on the market in the EU before they do in the United 
States. While we want devices to be available to American patients as 
soon as possible, we believe that, consistent with U.S. law, they need 
to be both safe and effective. The U.S. system has served patients well 
by preventing devices from entering the U.S. market that were later 
shown to be unsafe or ineffective.\9\
---------------------------------------------------------------------------
    \9\ See, e.g., D. Cohen and M. Billingsley, ``Europeans Are Left to 
Their Own Devices,'' British Medical Journal, 342:d2748 (2011), 
available at http://www.bmj.com/content/342/bmj.d2748.
---------------------------------------------------------------------------
    Some have suggested that the United States adopt the medical device 
regulatory system of the EU. Yet, outside the United States, pressure 
is growing toward greater premarket scrutiny of medical devices. A 
recent report concluded that ``[f]or innovative high-risk devices the 
future EU Device Directive should move away from requiring clinical 
safety and ``performance'' data only to also require pre-market data 
that demonstrate ``clinical efficacy,'' and ``[t]he device industry 
should be made aware of the growing importance of generating clinical 
evidence and the specific expertise this requires. \10\
---------------------------------------------------------------------------
    \10\ Belgian Health Care Knowledge Centre, ``The Pre-market 
Clinical Evaluation of Innovative High-risk Medical Devices,'' KCE 
Reports 158 (2011) at p. vii, available at http://www.kce.fgov.
be/index_en.aspx?SGREF=202677.
---------------------------------------------------------------------------
    There are significant differences between the EU and U.S. medical 
device review systems. In the EU, manufacturers must demonstrate safety 
and performance, while in the United States the standard for approval 
is safety and effectiveness.\11\ In the EU, more than 70 private, 
nongovernmental entities called ``Notified Bodies'' review and approve 
devices by giving them a ``CE mark.'' These decisions are kept 
confidential and not released to the public or to EU regulatory bodies. 
In fact, the EU does not have one centralized regulatory body. Instead, 
each country can designate an entity as a ``Notified Body,'' yet the 
decision of one Notified Body applies to all EU countries.
---------------------------------------------------------------------------
    \11\ See ``Recast of the Medical Devices Directives: Public 
Consultation,'' available at http://ec.europa.eu/consumers/sectors/
medical-devices/files/recast_docs_2008/public_consultation
_en.pdf;  European Commission, ``Guidelines on Medical Devices: 
Clinical Evaluation: A Guide for Manufacturers and Notified Bodies'' 
(Dec. 2009), at p. 4, available at http://ec.europa.eu/health/medical-
devices/files/meddev/2_7_Irev_3_en.pdf.
---------------------------------------------------------------------------
    Because of these factors, it is impossible to track medical device 
approvals, adverse events, or recalls in the EU, since there are few to 
no publicly accessible, centralized systems for collecting and 
monitoring information about medical device approvals or safety 
problems. The use of Notified Bodies has been criticized as encouraging 
``forum shopping'' by sponsors to identify those Notified Bodies with 
the most lax operating standards, and the varying levels of expertise 
among Notified Bodies has been critiqued.
    In May 2011, the European Society of Cardiology (ESC) issued a 
``case for reform'' of the European medical device regulatory system: 
that body's recommendations included creating a unified regulatory 
system, imposing stronger clinical data requirements, and requiring 
more accountability for notified bodies.\12\ The ESC cited examples of 
several different cardiovascular technologies that were implanted in 
patients in the EU that were later proven to be unsafe and/or 
ineffective through clinical trials required under the U.S. system, and 
were subsequently removed from the European market.
---------------------------------------------------------------------------
    \12\ See ``Clinical evaluation of cardiovascular devices: 
principles, problems, and proposals for European regulatory reform'' 
Fraser, et al., European Heart Journal, May 2011.
---------------------------------------------------------------------------
    Also in May 2011, a series of feature articles was published in the 
British Medical Journal, criticizing the opacity of the European 
medical device regulatory system, and raising concerns about the 
regulation of high-risk devices and how well they are tested before 
coming on to the European market.\13\ Several of the featured articles 
cited the FDA system's transparency as helping physicians to make 
informed decisions about which devices to use and providing patients 
with access to information about the devices that will be used on them.
---------------------------------------------------------------------------
    \13\ `` The Truth About Medical Devices,'' British Medical Journal, 
vol. 342. at pp. 1115-30 (May 21, 2011), available at http://
www.bmj.com/content/342/7807/Feature.full.pdf (Deborah Cohen, ``Out of 
Joint: The Story of the ASR,'' British Medical Journal 2011; 342:d2905; 
Deborah Cohen and Matthew Billingsley, ``Medical Devices: European 
Patients Are Left to Their Own Devices,'' British Medical Journal 2011; 
342:d2748); see also Fiona Godlee, ``Editorial: The Trouble With 
Medical Devices.'' British Medical Journal'' 2011; 342:d3123, available 
at http://www.bmj.com/content/342/bmj.d3123.full; Carl Heneghan et al., 
``Medical-Device Recalls in the UK and the Device-Regulation Process: 
Retrospective Review of Safety Notices and Alerts,'' BMJOpen (May 
2011), available at http://bmjopen.bmj.com/content/early/2011/05/12/
bmjopen-2011-000155.full.pdf.
---------------------------------------------------------------------------
    FDA continues exploring ways to get medical products to patients 
with serious and life-threatening diseases or conditions faster, but 
lowering U.S.-approval standards isn't in the best interest of American 
patients, our health care system, or U.S. companies whose success 
relies on the American public's confidence in their products. According 
to the IOM, ``FDA should be clear that its role in facilitating 
innovation in medical devices is to develop regulatory thresholds that 
are rigorous enough to satisfy the agency's primary objective of 
ensuring that marketed devices will be safe and effective throughout 
their life cycles but realistic enough to permit timely entry of new 
devices into the market.'' \14\
---------------------------------------------------------------------------
    \14\ Institute of Medicine, ``Medical Devices and the Public's 
Health: The FDA 510(k) Clearance Process at 35 Years'' (2011), at p. 
197, available at http://books.nap.edu/openbook.php?record_
id=13150.
---------------------------------------------------------------------------
    We are pleased that a U.S.-medical device industry trade 
association, AdvaMed, has stated that it supports maintaining our 
current rigorous standards of safety and effectiveness for marketing 
medical devices: ``The medical technology industry has long recognized 
that a strong and well-functioning FDA is vital to maintaining 
America's pre-eminence in medical technology innovation, and we support 
the current regulatory framework in the United States.'' \15\
---------------------------------------------------------------------------
    \15\ Advanced Medical Technology Association (AdvaMed), ``AdvaMed 
Statement on the House Energy and Commerce Subcommittee Hearing on FDA 
Device Regulation'' (July 20, 2011).
---------------------------------------------------------------------------
                               conclusion
    Over the course of the last 2 years, CDRH has been working, with 
extensive stakeholder input, to take concrete actions toward creating a 
culture change toward greater transparency, interaction, collaboration, 
and the appropriate balancing of benefits and risks; ensuring 
predictable and consistent recommendations, decisionmaking, and 
application of the least-burdensome principle; and implementing 
efficient processes and use of resources. These actions--geared toward 
a system of smart regulation--have already started to have a 
measurable, positive impact on our premarket programs, and we fully 
expect that positive trend to continue as we proceed to implement the 
improvements we have committed to make.
    MDUFA II is scheduled to expire on September 30, 2012, and FDA is 
ready to work with you to ensure timely reauthorization of this 
critical program. If we are to sustain and build on our record of 
accomplishment, it is critical that the MDUFA reauthorization occurs 
seamlessly, without any gap between the expiration of the old law and 
the enactment of MDUFA III.
    Mr. Chairman and members of the committee, I share your goal of 
smart, streamlined regulatory programs. Thank you for your commitment 
to the mission of FDA, and the continued success of our medical device 
program, which helps to ensure that patients and practitioners have 
access to safe and effective innovative medical technologies on a daily 
basis. I am happy to answer questions you may have.

    The Chairman. Thank you very much, Dr. Shuren.
    I had reserved some time for the Ranking Member to make an 
opening statement, but, we'll hold that. I will begin a round 
of 5 minute questions, in the order of appearance.
    Dr. Shuren, I've heard a lot of comparisons between FDA's 
review times for devices here to those in Europe. Some are 
touting the EU's system as one we should emulate; others 
express concern about the fact that in the EU, unlike in the 
United States, manufacturers do not have to demonstrate that 
their products are effective. Can you talk about the 
implication of that difference in our approval standards?
    Dr. Shuren. It's a very critical difference in our approval 
standards. As you mentioned in Europe, unlike in the United 
States, you don't have to show that your device is effective--
that, in fact, it really has benefit to patients.
    And, on top of it, that it is a system that is not 
transparent. The public does not know the basis for approvals, 
they don't even know about adverse events, unlike in the United 
States where we make that information available to the public, 
and the decisions to approve are made by private companies that 
are paid for by industry. In fact, there are over 70 of them, 
and concerns have been raised about inconsistent oversight, 
non-uniform expertise amongst those over 70 different 
companies, and form shopping from the manufacturers to those 
particular companies. In fact, the same kind of device could be 
reviewed by two different notified bodies, and they could ask 
for different kinds of information in both cases.
    We think the implications are huge--that we should not be 
exposing patients to devices that we don't know if they're 
effective. We think the U.S. standard is the right standard, 
but what we need to do is to assure that there is timely access 
to devices that are, in fact, safe and effective, and the steps 
we're taking are trying to get there.
    In fact, there have been a number of devices that have come 
on the market in Europe that later have been shown to be unsafe 
or ineffective. Many times when they are doing studies in 
support of approval in the United States, we're talking about 
heart valves, drug alluding stents, breast implants, device to 
detect breast cancer, device to monitor glucose, implanted 
wireless heart monitor, elbow implants, abdominal aortic 
stents.
    In fact, if you have ballooning enlargement of the large 
blood vessel in your abdomen, what you want to do is you put in 
a stent, a tube, so that the blood goes through that tube 
rather against the weakened walls of the artery which puts you 
at risk for rupture.
    In the EU, those devices have come on the market first, 
since at least the late 1990s. And yet, nine of those devices 
which didn't come to the United States, came on the market in 
the EU, and subsequently came off the market because they were 
found to be unsafe, and we don't think that's in the best 
interest of patients. We don't think that's ultimately in the 
best interest of industry.
    The Chairman. What are the weaknesses in your current 
postmarket authority? What, if any, additional authorities do 
you need to better track the safety of marketed devices? I sort 
of referred to that in my opening statement.
    Dr. Shuren. This is a question that was also put to us by 
the Institute of Medicine which recommended that we take a look 
back at our postmarket authorities. We are due to put out a 
response to their recommendations and that's currently going 
through administration clearance. So, it is an answer that we 
hope to get back to the committee very shortly.
    One of the issues we, ourselves, put on the table is about 
predicates, and are there circumstances where a device that's 
currently on the market should no longer be available for use 
as a predicate. That is a recommendation that we also plan to 
respond to as part of our answer to the IOM report.
    The Chairman. Actually, why--this is something I don't 
think very many people know--why aren't all implantable 
devices, things that go in your body, why aren't they 
considered high-risk and regulated as class III devices for 
which premarket approvals are required? How is it that implants 
like the metal hip implants, and I have a whole number of 
others over the last several years that have been done here--
bladder sling, surgical mesh, that type of thing--how is it 
they get evaluated through the 510(k) process, I mean things 
that are implanted in your body?
    Dr. Shuren. In some cases, it does make sense for an 
implantable device to be considered under 510(k), if it truly 
is moderate risk. And sometimes, we know that upfront. 
Sometimes we learn over time about that risk and we realize 
that, in fact, what was previously a high-risk device, we make 
a low-risk device, and we change that. Our law is based upon 
taking risk into consideration in terms of applying what our 
requirements are, and we take that very seriously.
    But you raise a very good case with the metal-on-metal 
hips. Those are devices, right now, that we have brought to an 
advisory panel to look at whether or not we should actually 
keep them in a class III, and we should put them on a premarket 
approval.
    In fact, in our efforts to not only apply risk, we also 
look to apply the least burdensome principle. I will tell you, 
we have done that inconsistently, and we're taking a number of 
steps to address that.
    But, in one of those cases, for the metal-on-metal hips, 
and this was the Depuy device, we, under the least burdensome 
principle, decided--you know what--we're not going to ask for 
clinical data in this case. And it turns out these are always 
tradeoffs and judgment calls as we try to figure out what the 
least justified burden is to impose on the company--that's a 
scientific decision--and sometimes we slide to a place, and it 
turns out not to have been the right call, and in the case of 
that particular hip, there were failures that we might have 
detected if we had asked for other kinds of information.
    The Chairman. I have a couple of followups. My time has run 
out. I'll do that in the next round.
    Senator Burr.

                       Statement of Senator Burr

    Senator Burr. Thank you, Mr. Chairman. Dr. Shuren, thank 
you for being here. I'm sorry I missed part of your testimony, 
but I read the written part.
    Let me ask you, why did it take 2\1/2\ years to put all 
these new proposals on the table that you highlight will speed 
up the process?
    Dr. Shuren. Actually, it didn't take us 2\1/2\ years to put 
them on the table. I will tell you, when I came in late 2009, 
and having heard concerns about the program, the very first 
thing I said, the best way to address this is let's assess it 
because we had industry saying that the program was not 
sufficiently predictable, consistent, transparent. It was 
stifling innovation and driving jobs overseas. But we were 
hearing from some of the consumer groups, third party payors, 
some of the healthcare professionals, that, in particular, the 
510(k) program was letting unsafe devices on the market and not 
providing good enough information to make well informed 
treatment and diagnostic decisions.
    My own staff had concerns that the current instantiations 
of those programs were not well-suited to some of the new 
technologies.
    Senator Burr. We're 2\1/2\ years down the road since then, 
and now, I don't want to cut you short, now your testimony is--
we have all these things that we're just putting in place, and 
they're going to solve a lot of the questions that have been 
raised.
    Let me read you your quote, tell me if it's accurate.

          ``Ninety-five percent of more than the 4,000 medical 
        device applications subject to user fees that FDA 
        reviews every year are reviewed within the goals that 
        were agreed to by the medical device industry under 
        medical device user fees amendment 2007.''

    Is that an accurate statement?
    Dr. Shuren. Yes, for the user fee goals. But I will tell 
you, in spite of that, no one's happy with the program because 
quite frankly, we're seeing that the total times are going up; 
so, while our times have gotten better since the start of that 
program, the total times aren't there, and so industry's 
unhappy, we're unhappy.
    Senator Burr. Let me tell you why some of the unhappiness 
exists because that statement, one, is misleading. It's 
misleading, first, because the FDA has not reported 510(k) 
performance data beyond 2009, second, the device center has 
failed to achieve 55 percent of its user fee performance goals, 
and third, user fee performance goals are based on a metric 
called FDA days. FDA days accrue when FDA, not the 
manufacturers working on an application to reduce FDA days, FDA 
can offload the work onto manufacturers.
    Let me just ask you simply, would you be in favor of going 
to calendar days? I think this would bring transparency and 
clarity, and better understanding of communications.
    Dr. Shuren. Sir, in terms of days, let me say for the FDA 
days, that's what we agreed to with industry, and actually was 
the deal then supported by Congress, and we've been following 
that and reporting on what we agreed to. But as part of our 
user fee reauthorization discussions now, let me premise by 
saying we've got ground rules in place, so please understand 
when there are limited things I can say about it, but I can 
talk about what's out there publicly.
    We've been talking about changing those goals to total 
time. Now that means that there are things you're going to have 
to expect from FDA--we're responsible for part of that time, 
industry is responsible for the other part of the times. Part 
of those discussions----
    Senator Burr. Maybe I was unclear in my question. My 
question was simply this, would you be in favor of switching to 
calendar days from FDA days?
    Dr. Shuren. If we're talking about total time? By calendar 
days, you mean calendar days where it's just with FDA?
    Senator Burr. Clock starts--doesn't get restarted, it 
continues to tick.
    Dr. Shuren. Oh, we're talking about the same thing, total 
days.
    Senator Burr. OK.
    Dr. Shuren. So, that's what we're talking about as a part 
of user fee reauthorization.
    Senator Burr. How do you explain the fact that since 2007, 
the original PMAs--the length of time that it takes to get 
processed has gone up 75 percent, to 27.1 months? The average 
number of months for clearance of a 510(k) since the 2003-7 
period has gone up 43 percent, to 4\1/2\ months' clearance. 
Tell me where the companies, based upon their user fees, were 
benefited in this process?
    Dr. Shuren. Yes, so first, in terms of--I'm not going to 
quibble over times, we may have disagreements. But, first of 
all, the problems----
    Senator Burr. Tell me where I'm wrong.
    Dr. Shuren. The problem started----
    Senator Burr. No, tell me where I'm wrong, don't just say I 
disagree, show me where my information is inaccurate.
    Dr. Shuren. Oh, for the timeframes? Yes, some of the 
timeframes are off in terms of the increases. But I would say, 
so what? So what? We all agree that times are going up, that's 
the important thing. And if you look at what's been going on, 
it started in 2002.
    Senator Burr. So, what's the answer to it, user fees? 
Increased user fees would eliminate this?
    Dr. Shuren. What's that? If you just throw money at it, you 
won't solve it. You need to do three things. We need to make 
improvements to the program--that's what we've been doing over 
the course of 2011. We do need to work with industry, and we're 
doing that right now with their representatives on assuring 
we're getting quality submissions.
    We're working on criteria for when we would not accept an 
application. It's exactly what the drug program does right now, 
and in fact, in a report we just put out on performance in the 
drug program, where we're now getting new tech, new device, new 
drugs, rather, on the market fairly quickly, one of the driving 
forces was the fact that companies are submitting higher 
quality submissions. We get it done faster.
    And the third part to it is we need to have the adequate 
resources to get the job done. If you just throw money at this, 
you won't solve it. But, if we don't have the adequate 
resources to get it done, we will fail, and ultimately, 
industry will fail, and that's why we moved forward on these 
assessments, which we wrapped up in 2010. It involved lots of 
input from the outside. In fact, not only did industry ask, but 
many Members of Congress came back to us and said, please don't 
rush to judgment--make sure you get lots of input.
    We tried to push forward quickly because we knew changes 
needed to be made. But we got from the Hill and from industry, 
don't do anything until everyone's had enough opportunity to 
weigh in. Then, we start in 2011 actually implementing, and now 
people are upset we're not moving fast enough.
    And, as it is, as a Federal agency, quite frankly, we get 
public comment on our policies. Now, that's good because we get 
lots of input, but it takes time. I mean, we live in a 
fishbowl. If a company were to try to make changes, and do it 
in a public process, they'd never get anything done. This adds 
time to what we're doing, and already, though, we're starting 
to see some things change.
    Let me show you something on 510(k), because you asked 
about it, if I could actually get chart six. I'd mentioned the 
problems here actually started in 2002. It's when we started 
seeing the first indicators where there was going to be reduced 
performance, and 510(k) started to actually increase in total 
time around 2004.
    This shows the number of 510(k)'s that are still 
outstanding at the end of the year. You can think about it as a 
backlog. We're looking from 2005--steady increase, year after 
year after year. But, now, finally, in 2011, as we're starting 
to make some changes, that backlog is coming down.
    If I can take the slide seven, what you'll see here is the 
percent of 510(k)'s that we make the decision to allow on the 
market. We call that clearing the device, and you'll see, 
again, back up, this is now with 2004, look at the top line, 
the percents in clearances is 88, it's just steadily coming 
down--year after year, 2011--the first time that number is 
starting to go up.
    Now, these are early indicators. We still have a long way 
to go. But much of the actions we're taking are still out 
there, draft policies for comment or draft process changes that 
are out for comment--that, in the coming months will be 
finalized and implemented, and yes, I do think, that we'll have 
a positive impact.
    Senator Burr. Chairman, you've been very accommodating, and 
I'll look forward to the next round.
    The Chairman. Thank you very much, Senator Burr.
    Senator Franken.
    Senator Franken. Thank you, Mr. Chairman.
    The Chairman. I just want to say in order--Senator Franken, 
Senator Casey, Senator Merkley, Senator Bennet.

                      Statement of Senator Franken

    Senator Franken. Thank you, and thank you, Dr. Shuren, for 
being here, and I appreciate the conversations that we've had, 
and I appreciate your going out to Minnesota. I understand 
you're going out again soon.
    Dr. Shuren. Yes, that's correct.
    Senator Franken. I think we'd all agree that patient safety 
is a priority of Congress and the priority of the FDA, and it's 
my job, and the job of the HELP Committee, to help you to 
protect patient safety to the best of our ability. As the 
Chairman said, there are different perspectives on all of this.
    I've spent many hours talking with patients across 
Minnesota, and they tell me that they want access to the newest 
treatments for their conditions, but too often, these devices 
haven't been approved. When I talk to medical device 
manufacturers in Minnesota, they tell me they're frustrated 
that they are developing innovative devices, but they can't get 
them to patients because the FDA hasn't approved them.
    That's why earlier today, I introduced the Patient Access 
to Medical Innovation Act with my colleague, Senator Alexander. 
This legislation will get devices to the market faster and more 
safely, I believe, by allowing the FDA to consult with experts. 
It will also reward companies for developing devices for 
patients with rare conditions.
    I believe this bill is a step toward making the process 
more efficient, and part of this is talking about what some 
consider--a lot of groups consider--the overly restrictive 
conflict of interest rules that exist in terms of the experts 
who have been in the industry--and you've talked in your 
testimony about the attrition that you've had at the top of 
experts, and so, that's what my legislation addresses, in part.
    When Commissioner Hamburg testified here in July, she 
expressed an openness to working with us on this issue in 
committee, would you be willing to work with us as well?
    Dr. Shuren. Yes, absolutely. We consider having access to 
the right experts to be critical, and so, I'm very happy to 
explore the issue with you. I'll add it's one of the reasons 
why we're setting up a network of experts.
    Just a few weeks ago, we put out standard operating 
procedures for working with healthcare professional societies, 
scientific organizations, to be able to tap into their networks 
that when we are dealing with challenging scientific questions, 
that we can rapidly identify who are the experts in the field, 
kind of supplement who the industry may be bringing in with 
experts and experts we may already have, so that we get a full 
discussion, we get the right people at the table to help us 
address those tough questions.
    Senator Franken. I really appreciate your working with Dale 
Wahlstrom in Minnesota, in talking about creating a center for 
studying regulatory science because that's really what we're 
talking about here.
    Dr. Shuren. That is very fair to say.
    Senator Franken. OK. I just want to get into the 510(k) 
proposals that the IOM made, and I think you and I are in basic 
agreement on things that we didn't like about it. Can you talk 
a little bit, though, about the things you did, like including 
postmarket surveillance and that kind of thing, and what you 
didn't.
    Dr. Shuren. I'm a little ham-strung at the moment.
    Senator Franken. OK.
    Dr. Shuren. As our response to the report is currently in 
administration clearance. But what I can say is, the IOM 
engaged in a thoughtful report. There's a lot of things in 
there, and to their credit, they also tried to look at a number 
of issues beyond just 510(k) at things that might affect the 
program like postmarket. They looked at software, and I think 
in the debate, while there was one key recommendation on 510(k) 
program where we felt, no, we shouldn't get rid of the program 
in its entirety. There are many parts to that report that 
really merit a good and thorough conversation, and in our 
response, we'll kind of come back with what our perspective is 
on all of the recommendations that the Institute of Medicine 
made.
    Senator Franken. I look forward to seeing that, and, in 
fact, you said, ``FDA believes that 510(k) process should not 
be eliminated.'' That's pretty, pretty clear.
    Dr. Shuren. And I stand behind that.
    Senator Franken. Thank you, Mr. Chairman.
    The Chairman. We'll have another round. Thank you very 
much, Senator Franken.
    Senator Casey.

                       Statement of Senator Casey

    Senator Casey. Doctor, thanks so much for your testimony 
and for your public service. These are hard issues.
    I wanted to ask you about, a kind of basic workforce issue. 
I'll start with a kind of a fundamental question about what 
some of the data has shown. Isn't it true that the data shows 
that the turnover rate is much higher for medical device 
reviewers than drug reviewers--is that correct?
    Dr. Shuren. That's correct. It's about double, and in fact, 
our drug and biological centers had this same problem many 
years ago, and same reasons--too much workload for the staff, 
not enough management oversight. In fact, for our premarket 
approval offices, the ratio of front-line managers to staff in 
some cases, are as high as 1:27, which is untenable, and they 
finally solved that through user fee discussions, and the drug 
industry, who, 10 years ago was not happy with the program 
rolling into PDUFA III, much like we're rolling into MDUFA III, 
and they finally said, ``You know what, we're not happy with 
performance, but we recognize if we're going to address a lot 
of these problems, we have to make sure that you are 
sufficiently funded to get it done,'' and with us, some of 
these problems with high turnover, we're not going to solve if 
we don't have enough people to do the work, and enough managers 
to assure that we have good adult supervision.
    Senator Casey. That leads me to a question--I would like to 
know what direction you are heading in, and what FDA is doing 
to make an investment in its reviewers? How do you deal with 
this basic problem of high turnover?
    Dr. Shuren. One step is to make sure we provide them with 
good training opportunities, and to make the processes as 
streamlined as possible.
    Let me tell you about training. One of the things I 
encountered when I came to CDRH is that we had no standardized 
training program for our new reviewers. So we have now 
instituted and just launched in September a reviewer 
certification program where all new reviewers will go through 
standardized courses, and they go through oversight of the 
applications that they're reviewing. We're going to audit that, 
see if it works, and from there, think about expanding it, if 
appropriate, to some of the other reviewers as well.
    We're also getting ready to launch what we call an 
experiential learning program. We think one of the ways to help 
keep us on top of new technologies is to get us out of the FDA 
to actually get our reviewers, get our managers to go out to 
manufacture facilities, see the new technologies that are being 
developed, go out to healthcare facilities, see the 
technologies in real world use.
    Right now, we've tried it on more of a pilot basis and 
we've gotten very good feedback. It is my hope as we mentioned 
with resources, that we'll also have not only enough people to 
get, do the work in a timely manner, but also that our people 
can also take time off to go get this training. Because one of 
the challenges my staff face everyday is a gallon workload and 
they're getting judged on the workload and they're moving the 
workload at the same time. We'd like them to leave the workload 
for a little bit of time, and get out of the office, and get 
that training, and that means we need enough people to both 
move the freight, if you will, and to let people take the time 
off to get such critical training.
    Senator Casey. I have a related question. In some fields 
such as healthcare, there is a lot of turnover and often it's a 
burnout factor. Along those same lines you just described, what 
are you doing about recruiting and staff retaining? Because 
sometimes you're going to have a problem with both. Your 
recruiting can go well, they get in the door, but you can't 
retain them. In other cases, it's the opposite or sometimes a 
combination of both. What are you doing about that? Have you 
already answered that or is there something additional you'd 
like to add to that?
    Dr. Shuren. The critical issue here comes down to funding. 
I will tell you right now for one of my offices, premarket 
office, it takes about three people to bring on board to 
actually get a net gain of one person because of the turnover 
rate, and in some cases, I can't really pay for people, for 
some of the top-notch people to come out from the private 
sector, to come to the FDA and stay at the FDA. It's one of the 
issues they also addressed in the drugs program.
    Right now, it's on the table that we're talking about as a 
part of user fee reauthorization. But, I really would like that 
ability to be able to pay some of these very highly talented 
people to stay in their jobs rather than leaving. In fact, 
right now, almost half of my reviewers have 4 years or less of 
experience, and from my front-line managers, more than half, a 
little over half, have only 3 years or less experience, and 
that turnover--oh, I was saying that almost half of my 
reviewers have 4 years or less experience because they wind up 
leaving. And from my front-line managers, little over half have 
about 3 years of experience or less. And we know even from 
industry that these disruptions and new people coming through 
disrupts the review that's going on.
    At the same token, I can do all the training in the world, 
but if these people are leaving, I've lost that, if you will, 
that investment. It's one of the challenges I have on least 
burdensome principle, which, by the way, I'm very committed to. 
I mean, to me, I consider that good government, that you're 
looking at what is the least justified burden that you impose. 
But, if I'm constantly dealing with new people, it's much 
harder to get them up to speed on what the expectations are 
when we apply that principle, and I think if we can break this 
cycle, we'll win.
    It's one of the reasons why, and I empathize with industry, 
by the way--they are paying more money, they're not seeing the 
kind of performance they want to see. But quite frankly, what 
we never tackled is making sure we have enough resources, not 
only to handle the workload, but to actually get over this hump 
of too much workload for the individual people, and not having 
enough managers. And if we can break that cycle, then we will 
have a program where people stay, they get trained up, they 
stay. We have enough people to do the work. We make the other 
program improvements in policies and processes, then we have a 
top-notch medical device program.
    And last, and let me say, I am not trying to put down my 
staff. They are amazing. I have very talented people, but I 
don't think we've quite served them well in making sure they 
have the tools available, the oversight available, and the 
opportunities available where they can really thrive and have a 
good work place.
    Senator Casey. We've heard a lot about this in 
Pennsylvania, so I appreciate your answers. Thank you.
    The Chairman. Thank you, Senator Casey.
    Senator Bennet.

                      Statement of Senator Bennet

    Senator Bennet. Thank you. And just to pick up where 
Senator Casey left off, we've heard a lot about this in 
Colorado, too, and my understanding, Dr. Shuren, is that, 
actually, you even lose people to other parts of the agency 
where people are able to compensate better than the device 
section.
    Dr. Shuren. That's correct.
    Senator Bennet. I want to thank you for all the time you've 
spent with me, and in Colorado as well. I deeply appreciate it, 
and as you know, Senator Burr and I on the committee introduced 
medical device legislation, along with Senator Klobuchar. And 
we hope to make headway here on the HELP Committee, Mr. 
Chairman, on this legislation.
    A lot of the bill stem from the idea that FDA should not 
make approval longer or more costly than is necessary to meet 
the statutory standard of reasonable assurance of safety and 
effectiveness. I certainly think a pragmatic approach like this 
makes sense. And it seems the FDA has acknowledged this need 
for pragmatism as well. I'm referring to the least burdensome 
guidance document from 1997, and you just raised that concept 
in the context of training. So, I'd like to hear you a little 
bit more on this least burdensome concept. How important is it 
to the agency. Is it a priority for you? And in addition to the 
training that you just talked about, because I don't want you 
to have to repeat yourself, how can FDA better apply this 
concept?
    Dr. Shuren. So, it is important for me, and it's something 
that I, personally, am committed to. In fact, over this summer, 
I sent out a central-wide email reaffirming our commitment to 
the least burdensome principle.
    In fact, for folks who may be interested, that report I 
mentioned from about a month ago--and there's no new activities 
in here--it's encapsulating things that we talked about 
beforehand, but what we put on our Web site is an attempt to 
link all the different actions together that we're taking while 
we're taking them. And you will see in there, in our top three 
objectives, one of them actually pertains to least burdensome 
principle. And along with it, even a chart that lays out 
everything we're doing. If we put something out, we actually 
provide the link to that information. If not, we give a 
timeframe for when we think it's going to come out.
    For least burdensome, one of the things we've been doing as 
a change is, first of all, in our guidance documents--try to 
more and more, in the guidance documents, themselves, apply the 
least burdensome principle as opposed to just say something in 
front as a boilerplate. It's really critical we put that in the 
guidance themselves, and we've done several of those over the 
past year, so it's very clear for our staff, and it's also very 
clear for industry.
    The other is assuring that when we're making decisions, and 
we're going to, if you will, ask for something more, or 
something different, that that decision is being made at the 
right level of management. Too often, that decision was being 
made at the reviewer level. So, we have now put out a change in 
our standard operating procedures saying for these kinds of 
decisions, they've got to be made at this level. And, again, 
another check is to make sure that we are applying the least 
burdensome principle.
    In fact, a few months ago, we created a center science 
council comprised of our senior leadership. It includes myself 
and experienced scientists who now oversee those programs, 
again, for science programs for ensuring consistency, 
predictability and application of the least burdensome 
principle. Some of the most important scientific questions are 
coming up there. And I will tell you that in some cases, we've 
actually come back to say, we're going to do something 
different than what was recommended. In part, it's an 
application of the least burdensome principle.
    Senator Bennet. I want to thank Senator Burr for his help 
on this, and also say how much I'm looking forward to working 
with the agency to try to get this done.
    In your testimony, you cited some statistics about venture 
capital investing, and seemed to be suggesting U.S.-venture 
capital investment medical devices is healthy. I want to call 
your attention to a recent survey of life sciences, VC 
investors by MVCA, which found that our venture capital 
companies are deciding to use their dollars to invest overseas 
in places like Europe and China rather than here because of 
their lack of confidence in our regulatory system.
    I want to mention the importance of first-time funding 
statistics. It's the measure of how many new technologies are 
being taken directly from the lab and to development, that 
first-time funding is down. That means in the future, there 
will be fewer technologies advancing toward the market at all 
stages of the pipeline. According to the Pricewaterhouse 
MoneyTree Report, first-time fundings of medical device 
companies fell more than 60 percent from 2008 to 2010, and 
total medical device VC investment fell by more than $1 billion 
during that same time period. So, in light of that data, I'd be 
interested to know whether you think we ought to be worried 
about those trends.
    I'll say that I'm worried about it for two reasons. One is 
that, I actually don't think there's a place where it's about 
balancing safety and innovation. Actually, we need the 
innovation for the sake of our patients, which is my principal 
concern. The other is in States all across the country, 
Minnesota's one, Colorado's one; we really see much of our 
economic future in the development of these innovations. And 
so, that's why you're hearing from the two of us and others 
about this. And I want to make sure that we've got an ecosystem 
in this country where venture capital is being invested here, 
and not going to Asia instead out of frustration. Do you want 
to respond to any of that?
    Dr. Shuren. Yes, I want to see the venture capital dollars 
flowing here in the United States as well. I'll tell you, one 
of the things I heard from the VC community, and quite frankly, 
I've been spending a lot of time traveling around the country. 
Rather than expecting people to come to Washington, DC, I've 
been going out there, and I've been out to Colorado----
    Senator Bennet. And I can vouch for that.
    Dr. Shuren [continuing]. Minnesota. Many times, been to 
North Carolina, and all of this is to really hear from people 
directly. We've held town hall meetings where anyone from the 
public can come.
    One of the things the venture capitalists have said is, 
where they'd like to have the ability to start clinical trials 
in the United States earlier. And the reason is, a company will 
bring their device to a group of doctors. They'll do some 
testing, and when they come back to do more testing, they go 
back to the same group of doctors because those are the doctors 
who have experience with the device.
    So, these early tests, they're called early feasibility 
tests--are so important. That's why just last week, we put out 
a new policy on these early feasibility, and in some cases, 
first in-human studies, that would allow them to start in the 
United States earlier in the device development pathway than 
has occurred previously. And to allow companies to make changes 
to that device without necessarily first having to come back to 
FDA. Because as you know, with a device, the early prototype is 
not the one that's going to eventually be sold on the market. 
They test it, they learn from it, they make changes. We're 
trying to create a more rapid innovation cycle here in the 
United States. And we think if we do that, that becomes a 
greater incentive for the VC community to invest here, and I 
think that is good for small companies who are really putting 
up and developing these new technologies.
    Senator Bennet. Thank you, and thank you, Mr. Chairman, for 
your indulgence.
    The Chairman. Senator Mikulski.

                     Statement of Senator Mikulski

    Senator Mikulski. Good afternoon, Dr. Shuren. I'm glad to 
see you and to welcome you to the committee. I want you and the 
people who work at the FDA--the several thousand, almost 7,000, 
who work at FDA in food, prescription drugs, and medical 
devices--to know how proud we are of the job they do every day. 
The fact that we are as safe as we are in regard to our food, 
drugs and medical devices says something must be working. But I 
think we all agree it must work better.
    I want to go to the personnel issues and rapid turnover 
raised by Senator Casey. What is the reason for the rapid 
turnover? Is it all money? Or is it also the fact that Federal 
employees--in particular, FDA employees--have often been the 
subject of a sustained, relentless, and persistent demonization 
as ``pointed-headed PhDs'' ``Pointed-headed bureaucrats--
technocrats? '' Maybe I'm wrong.
    People come to FDA because they want to make a difference. 
Why then, don't those same people stay in their jobs when every 
day FDA is actually making a difference?
    Dr. Shuren. You're spot on. First off, we did an 
organizational assessment of CDRH in 2010, and found that the 
commitment to the mission is actually off the charts. Over 90 
percent of my staff, committed to the mission, were willing to 
put in extra time, which is beyond what you see in most 
industries.
    But at the same time, morale is hurting. And the No. 1 
thing I hear--I just had one of my office directors back in my 
office again a few days ago--was this issue of demonizing. 
That, for so long, all they have heard from the device 
industry, all they've heard, and I really do not mean this as a 
negative comment, but from many colleagues here on Capitol 
Hill, much has been focused on what's wrong. And my people 
everyday are working hard, and if all they hear is, ``you're 
doing a bad job, there's something wrong with you,'' that kills 
morale.
    In fact, it is really hurting my ability to try to drive 
change at the FDA. It's one of the reasons, as Senator Franken 
mentioned, Dale Wahlstrom at LifeScience Alley, he and I have 
been talking about--how do we change that dialog? Because if we 
don't do that, if we don't change the atmosphere, if our people 
actually don't hear about when they're doing things right--if 
the things we're doing I'm talking about today makes sense, my 
folks need to hear that. Because, otherwise, we won't be able 
to make those changes, we won't change the morale issue, and 
we'll continue to lose people. I've got to fix the morale, and 
we will have to have the people to reduce that workload, and 
also make sure I've got the managers.
    Senator Mikulski. Well, first of all, I am also deeply 
troubled by the demonization. It has shifted focus away from 
the regulatory process and the IOM report. In other words, the 
focus is on demonization rather than acquisition of valid 
information from either industry or learned societies through 
debate, discussion, and ultimately problem-solving.
    But let's also talk about the issue of money. Does the talk 
about 2-year pay freezes and other monetary proposals being 
directed at Federal employees also exacerbate the discontent?
    Dr. Shuren. I think it's a contributor. I mean, on the flip 
side, though, quite frankly, everyone knows the tough straits 
we're in as a country. There are people without jobs today, 
there are people who can't find work. And my people get that, 
they really get that.
    Senator Mikulski. We're facing a joint committee report. If 
the joint committee fails to act, or we fail to adopt the joint 
committee recommendation, we will go to a sequester. The 
sequester, though not until next July, would mandate what I 
believe is an 8.5 percent across the board cut.
    What would the impact be on your operation in light of such 
a cut--the literal functionality of it--regardless of how well, 
able and bi-partisan our MDUFA reauthorization is? What would 
the impact be on you? I'm not asking about which three jobs 
you'd need to lay off. But, instead I'm asking what you think 
the impact would be on your ability to recruit and retain 
during this year, facing both a sequester and the current 
demonizing?
    Because first, there's the specter of demonization, which I 
think is just wrong. I just think it's wrong. Quite frankly, 
it's unbecoming for an American democracy to not recognize that 
we need an independent civil service. One of the hallmarks of 
great democracies is that they all have an independent civil 
service. Regardless of who is in charge, independent civil 
service serves the Nation.
    Then, there's also the fact that there's the sequester. 
What would the impact of both of these concerns be on morale 
and recruitment and retention?
    Dr. Shuren. It would have significant adverse impact. I 
mean, our program, first off, unlike the drug program, is 
predominantly dependent upon congressional appropriations, that 
is where we get most of our money. And a big cut means that, 
not only are we at risk of losing people, but people know that 
the workload goes up, so the work environment deteriorates. We 
won't be able to, then, bring in people to handle that 
workload. I won't be able to keep my good people there, the 
first people who leave, and, ultimately, the program spirals 
downward.
    Senator Mikulski. I know my time is up. Let me just say 
this. First of all, I'm so glad to hear you want to go out and 
meet with those who are working on innovations in technology 
and manufacturing. The reason so many of us are here today is 
that those types of industries create great jobs in our States. 
People working in my medical device community are so excited 
that they're actually building a product that saves or improves 
lives.
    And their work creates an export product, so they're 
excited about that too. We've got to work together on this 
issue. This is really, truly an opportunity for jobs, 
innovation, and exports. I think what we need is to value our 
civil servants, and let them know they can count on us. If we 
do that, then we can count on them as we go through this 
process.
    On behalf of myself and Senator Cardin, I would like to 
thank our employees at FDA. We're really proud of you. We've 
got a lot of reform ahead and a lot of self-reflection to do. 
But I think self-reflection starts up here in the Senate as 
well.
    The Chairman. Thank you, Senator Mikulski.
    Senator Blumenthal.

                    Statement of Senator Blumenthal

    Senator Blumenthal. Thank you, Mr. Chairman. I want to join 
Senator Mikulski in two points that she made so well. The first 
is that the folks at the FDA, the people who work so hard and 
well are really doing an enormous public service for the 
American people. And probably, their only fault, and it's not 
their fault, is there should be more of them to do the work 
that's required.
    And second, that demonization never makes sense in a 
democracy, by definition, it makes no sense because to demonize 
is, essentially, to shift the blame and focus it unfairly.
    But, I want to raise a more philosophical question which 
comes to me from my work at the State level where we have 
agencies that are funded in whole or in part by the industries 
that they are supposed to regulate. And, in terms of public 
credibility, and long-range outlook, I realize it may not be an 
issue for this reauthorization. Aren't we doing a disservice to 
the FDA by making it as dependent as it is on funding from the 
industries, not just device industry but pharmaceutical and 
others, that it is supposed to regulate?
    Dr. Shuren. It's an important philosophical question. I 
also look at it, though, as a pragmatist. I know the near 
impossible task that faces this Congress, about figuring out 
where the dollars go. You have to make tough decisions all the 
time. We know there's less money available than before, so, 
realistically, for us to look at the U.S. Congress as, we're 
going to continue to see the kind of increases we may need to 
support the program. I don't know if you're in a position to do 
that.
    So, on its alternative, there are user fee dollars to 
support us and to make sure we can get the job done. What's 
critical when we set up these programs is that those dollars 
support the overall program. There's not like a cut check to 
individual people, so we kind of keep it separate from, if you 
will, the dollars coming in, and the decisions being made.
    And the second thing is that, on the flip side for 
industry, I know for them, though, it kind of changes the 
expectations that they have on the program. What I would like 
at the end of the day is to have an adequately funded program. 
I'm almost, I will tell you, personally, agnostic on the 
source. As long as we have the people we need----
    Senator Blumenthal. Oh, you're agnostic on the source. I 
don't mean to interrupt you unfairly, but, the answer you've 
given is sort of the second part of an answer that you haven't 
given, which is, in the best of all worlds, you'd be funded 
independently, but given the fiscal constraints of the moment, 
pragmatically and realistically, as you've put it, probably, 
this source of funding is the one that we need to rely on.
    But, in terms of public credibility, I just wonder whether 
we aren't doing the agency a disservice by making it so 
dependent on the industry's funding. Certainly, it is raised, 
commonly, and the public is increasingly aware of it--that it 
depends on the industry. And frankly, at the State level, we 
have it happen, and the same reaction is prevalent--whether 
it's the utility industry or the banking industry, or the 
insurance industry--as happens at the State level.
    Dr. Shuren. Yes. And I recognize, also, perception can just 
as much be a reality as facts are. And I know that there are 
many who feel that, because we receive user fees, that that may 
taint the decisions that we get.
    All I can tell you is, I don't believe it does taint our 
decisions. And, however, that funding is provided, as long as 
we are free to make our independent scientific determinations, 
and we have the funding to get the job done, and done right and 
quickly, then I think we're in a good place.
    Senator Blumenthal. You may not have the time, I'm 
guessing, almost certain that you don't have the time, but what 
I would like you to give me, perhaps in writing, is your 
analysis of the three instances of FDA failure. And what you 
think we should learn from them going forward. In other words, 
case studies--I'm not asking you for a full case study, but 
what you would point to as what we should regard as failures--
and the three success stories. And if you want, you can make 
them five, you can make them seven on each side.
    You can, but what I would like is an analysis of where you 
regard the failures as having occurred, and what we should 
learn from them. Because I think that will be useful as an 
exercise for us, for me, as new to the committee and new to 
this area compared to other members of this committee.
    Unfortunately, my time has expired, so it's a question 
that, for better or worse, you won't be asked to answer. But if 
you could provide it in writing or in some other form, I'd be 
grateful for it.
    Thank you, Mr. Chairman.
    The Chairman. Thank you. We'll begin just a short second 
round.
    Dr. Shuren, FDA acted very quickly to reject the core 
conclusions of the IOM report on the 510(k) process. I'm going 
to ask why, but I'm going to preface that question by saying, 
we put a lot of faith in the Institute of Medicine and the 
National Academy of Sciences. And I can tell you there are 
times in the past when they have come out with findings that I 
probably didn't like for a certain, political reason, or that 
might have gone against a, perhaps a, constituent of mine. But, 
we recognize the soundness of the process of the National 
Academy of Sciences and the Institute of Medicine.
    So, their request to do this, they said here in their 
conclusion, they said that the FDA asked the Institute of 
Medicine to review the 510(k) clearance process, answer two 
questions. Does the current 510(k) clearance process optimally 
protect patients and promote innovation in support of public 
health? Answer: No. Second, if not, what legislative, 
regulatory or administrative changes are recommended to 
optimally achieve the goals of the 510(k) clearance process. 
Their answer was probably, ought to get rid of it and come up 
with a new regime. Why did you reject the core conclusion of 
the IOM?
    Dr. Shuren. Because we think that the 510(k) program, in 
most cases, has actually worked well. If we're going to be 
thinking about changing it, putting something else in place, 
I'd first ask, what are we putting in place instead of it, 
which is a question the Institute of Medicine felt they were 
not in a place to actually say?
    And the second is to just, at the outset, get rid of the 
program, which would be highly disruptive, and before anyone 
would think to do it is, then what are we gaining in return? Do 
we have an alternative program we're actually turning to that 
can ensure safety and effectiveness? Is it going to do a better 
job than what we have right now? And what about a transition to 
a new program? What will the impact be?
    So, for us, we thought that getting rid of the program in 
its entirety was going too far. That said, much of what we are 
doing in this past year is about improving the programs that we 
have. And we still welcome additional thoughts, if there are 
other actions that we need to take. And if so, we'd be very 
happy to consider them.
    But, it's more focused on making the programs we have work. 
And some of those products have, kind of, fallen, I'll say a 
little bit on the wayside.
    The Chairman. I understand that. Thank you very much.
    Senator Burr.
    Senator Burr. Thank you, and Dr. Shuren, I, for one, 
commend the FDA on their decision on the 510(k) because I think 
that it does embrace what it set out to, and it establishes a 
pathway for devices that have an equivalence that's 
established, and I think it was the right thing.
    The industry says delays in reviews are because FDA keeps 
moving the goal post, causing regulatory uncertainty and lack 
of predictability in the review and approval process. In 
contrast, the FDA has repeatedly said that the problems at the 
device centers are the industry's fault.
    Now, you highlighted earlier that there are improvements in 
approval times. And I think you said that companies are 
improving in the quality of their applications. Did I hear that 
accurately?
    Dr. Shuren. No. First off, I would say we have not been out 
there saying the problems are all due to industry. I've been 
saying for a long time, now, that actually the problems are 
multi-factorial, and a good part of it is due to the FDA. And 
that's what I tried to make clear in my opening statement, and 
I've said this to Congress on the House side several times 
before, and in other forums.
    One piece of it is we do get from a number of companies 
submissions that are of poor quality. And unlike the drug 
center, which will send them back, we'll let them in. We'll 
work with companies, we'll take it and we'll go many rounds to 
try to get it right. But, as a result, it's making us 
increasingly more inefficient. That is just one piece.
    Senator Burr. You would agree that quality applications are 
an incentive for a company to move through the process as 
quickly as possible?
    Dr. Shuren. Here's been the challenge. When we take in a 
submission that may not be of sufficient quality, and we're 
going to work with them, we actually end up doing some of the 
work for the company. We've had companies who come in; they 
don't even identify the predicate device.
    Senator Burr. Let me, I'm trying to make this easy for you. 
You would agree that a quality application enhances the 
timeline, and there's an incentive there for the manufacturer 
to have a quality app, is that an accurate statement?
    Dr. Shuren. Yes.
    Senator Burr. OK, great, you made a statement that you 
haven't been out there bashing the industry. In fact, in a 
response to the perception that FDA's to blame for the increase 
in 510(k)'s, you were quoted in February as saying, ``Those 
510(k) times are all on the industry.''
    Dr. Shuren. I would be interested to see the quote and it's 
context. If we're talking about the times, the increase in 
times or the increase in the industry times, that is correct. 
But the factors that led to the increase in times are due to 
things on our end, and some things that are on industry's end. 
So, hopefully, I will go back and see that quote in context.
    Senator Burr. This was reported in the Medical Device 
Daily. It was in an ENC Subcommittee hearing in February, and 
your quote was, ``Those 510(k) times are all on the industry.''
    Dr. Shuren. So, if it's ENC Committee happy to go back, and 
we'll pull the testimony to go ahead and look at it.
    Senator Burr. I've learned that press is accurate, no 
matter what they say.
    Dr. Shuren. You must be dealing with a different press than 
I'm used to. No offense to the press who are here.
    Senator Burr. Bottom line, the average total times is 
getting worse instead of better. While the agency may not be 
held responsible for every single submission, doesn't the fact 
that the average total time getting worse clearly shows the FDA 
is contributing to the problem? I think you admitted to it 
earlier.
    Dr. Shuren. I agree, we're part of the problem. And I've 
said we've not managed the programs as well as we should have, 
and that's why you're seeing a number of the actions we're 
taking are improvements on the FDA programs, the things we need 
to do better.
    Senator Burr. I looked at the official meetings that were 
published by the FDA, on the medical device user fee agreement. 
Those negotiations suggest that the agency is requesting more 
than a 250 percent increase in user fees from current levels.
    Let me ask you, would you agree to pay somebody any money 
at all, much less a 250 percent increase above what they are 
currently paying, when the terms of what you're paying for 
aren't being met?
    Dr. Shuren. Yes, in some cases, I actually would. I know 
this for research and development. Quite frankly, if you put a 
little bit in research and development, you may not get enough 
out of it. You just have to put enough into it, you get enough 
of a return.
    To sing for our program, and it's why I empathize with 
industry, I actually do because they haven't seen that return 
on investment, at least in numbers that they would like to see, 
and to make the argument that in the absence of the funding, 
things would have been worse, that is true, but a hard case to 
actually show somebody.
    But at the same token, those fundamental problems that we 
showed in the program, some of them are due to not having 
enough people, having that high reviewer turnover, not having 
enough managers, and I can't solve with some missive that I 
send out to my people. I can't solve that with a pep talk.
    Senator Burr. Do you acknowledge that an increase in the 
user fee is eventually passed on to the consumer? In other 
words, an increase in the user fee raises the cost of 
healthcare in this country?
    Do you agree?
    Dr. Shuren. Actually I don't know. And if you're saying, 
then, the companies are passing it on to consumers, then on the 
flip side, you're saying that the companies never actually 
absorb the increase. In which case, they're not really paying 
any more money. And that's not what the companies are telling 
me. The companies are telling me, if they have to pay more, 
it's coming out of their hides. So, I'm assuming they're not 
passing it on to the consumers, in which case----
    Senator Burr. I'm not going to get into negotiations that 
you're having with the companies. But I think, throughout 
healthcare, any place that we exercise an increase in the cost, 
that finds its way to the consumer. It finds its way to 
healthcare at a time that we've got to take $4 trillion out of 
healthcare. I think you've got to weigh in this equation. How 
much are we increasing the cost of devices? It troubles me, and 
I think, I would hope that it would trouble you, that most 
companies across this country tell horrific stories about going 
through the approval process at the FDA.
    You talked about the venture capital earlier. I won't get 
into it, but the majority of the companies that come in to 
file, are publicly traded companies. They've got a market 
capitalization that they've got to be worried about. The 
uncertainty of the process will dictate whether, in fact, they 
decide to go for FDA approval. But, I will assure you at the 
end of the day, if it negatively impacts their market capital, 
they'll make a decision not to get involved. Not unlike the VC 
community's decision as to whether they're going to get in with 
a company pre-going public.
    So, capitalization, whether it's on the VC side or whether 
it's in market capital, is affected greatly by the decisions 
that these companies make. And I think, need to be considered, 
from a standpoint of how it's affected by the process that we 
set up. I hope that's something that's food for thought for 
you.
    Mr. Chairman, I apologize, you gave me a tremendous amount 
of time, and I have cheated my good friend and colleague, 
Senator Hatch.
    The Chairman. Does anyone have any further questions for 
Dr. Shuren before I dismiss him and bring up the next panel?
    Senator Hatch. Could I ask a few, Mr. Chairman?
    The Chairman. Senator Hatch.

                       Statement of Senator Hatch

    Senator Hatch. Thank you so much. Dr. Shuren, I appreciate 
the work you're doing, and I appreciate the FDA, in general. 
Multiple reports that examined FDA's databases, found that FDA 
has an extraordinary safety record over the past decade.
    Furthermore, the IOM stated that there was no evidence to 
suggest patients are being exposed to unsafe or ineffective 
products. Based upon these findings, why has CDRH seemingly 
diverted precious financial and strategic resources away from 
the premarket review process, and focused on overhauling a 
program that really seemed to be working, pretty doggone well, 
and for which you were complimented?
    Dr. Shuren. Actually, a lot of the actions we are taking 
are to improve the predictability, consistency, and 
transparency of that program, and industry has complained about 
that program not being sufficiently predictable or consistent 
and transparent.
    In fact, many of the actions we're taking are based upon 
feedback that we had received as we've gone across the country 
to get input.
    Senator Hatch. Some of the things I'm asking may have been 
asked already. But, sorry, I missed the early part of this. I 
was at the Judiciary Committee.
    Dr. Shuren, FDA performance data shows that the 510(k) 
review times have increased 43 percent in just 4 years, and PMA 
review times have increased 75 percent. When American industry 
is losing its competitive edge and when patients are waiting 
longer and longer for new treatments and cures, that's a matter 
of great concern to me.
    Now, you've said that the agency has implemented reforms 
and announced initiatives to reduce these approval times, but I 
have yet to hear from you any specific actions you will take 
that will require a guarantee that these approval times will be 
reduced. And, let me just ask this question, what metrics are 
you using to measure the success of these initiatives and 
reforms?
    Dr. Shuren. We're looking at some right now, indicators on 
performance, and I apologize. I showed one a little bit earlier 
regarding our backlog on 510(k)'s, which in 2011, for the first 
time was coming down. We've looked at, kind of, the percent of 
510(k)'s that we're now clearing, going on the market. We've 
got to be a little bit careful on that number because we should 
only clear a device that, in fact, is substantially equivalent. 
But that number has actually been going up.
    Some of the measures we're looking at are showing early 
signs we're going to be looking at our performance in terms of 
the times on the review clock for products coming to market. 
But, I'll tell you for success, it's going to require that we 
continue to make the improvements we'd laid out. If there are 
things that we missed, we still want to hear about it because I 
keep going around asking people, and people saying, ``well, 
that sounds like the list.''
    We talked a little bit about what we need to do with 
companies, making sure we do get quality submissions. And also 
said that we won't be successful if we don't have the adequate 
and stable resources. And I'll say right now in terms of the 
fees being paid, like I said, I empathize with industry, but in 
the one case of 510(k) right now, the full fee is $4,000. And 
if you're a small business, which is $100 million in annual 
sales or receipts, it's $2,000 for a 510(k). And yet, we say, 
for some more money, if we can reduce the times, and it's not 
just the times on review, if you have greater predictability, 
you actually reduce the time on assessing that device, which 
we're not even measuring.
    I mean, you're talking about--you could be looking at 
important savings. And yet, you could say, ``Well, suppose I 
increase that fee $3,000? '' And yet I save days and people are 
telling me in the industry, every day lost is thousands of 
dollars, that, to me says, if I save 1 day, you may have gotten 
your return on the investment, in that 1 day.
    And those are part of the user fee discussions right now. 
But, so, for success, we need to make sure we've got the 
resources, we need to work on the submissions coming in. But, I 
have to say, again and again, FDA has to do a better job. And 
those are the actions that we're taking now.
    Senator Hatch. I appreciate that, and I appreciate your 
attitude about it. And we've met about it, and we've chatted 
about these matters, and it's a tough job you have. But, some 
find it shocking that the average time to clear a 510(k) 
application has increased 50 percent since 2002. The average to 
approve a PMA application has doubled since 2000, and the total 
review times for both 510(k) and PMAs are now, actually, longer 
than they were before the user fee program was instituted.
    Now, these statistics are from FDA's own data, as you know, 
yet user fees for CDRH have increased by nearly 30 percent. I 
know you agree that these statistics are somewhat troubling, 
they are to me, and I'm very appreciative that you're on top of 
these things, and willing to do something about it. And I hope 
that you can. Because I think we're falling behind the rest of 
the world in approvals and yet we have some of the most 
imaginative and intelligent people working in this country, 
compared to the rest of the world.
    So, you have a very important job, in my opinion, and I'm 
looking to you to improve the Agency's performance. And I'm 
counting on you.
    Thank you, Mr. Chairman.
    The Chairman. Senator Hagan.

                       Statement of Senator Hagan

    Senator Hagan. Thank you, Mr. Chairman.
    Dr. Shuren, I appreciate you coming before the committee, 
but I also appreciate your time in September when you came down 
to North Carolina to meet with the hard-working innovative 
medical device companies in my State. In North Carolina, we 
employ over 8,000 people in the medical technology industry, 
and it's an industry that really does create thousands of jobs. 
And I know that it was interesting and invaluable to hear their 
perspective as well as the FDA's, so, thank you.
    I know that you've made efforts already to improve the 
quality of work among reviewers, and I appreciate your efforts 
to increase reviewer training, thank you on that. But, one 
complaint that I continue to hear from constituent companies is 
that the FDA's medical device review process is unpredictable 
and inconsistent, and I know you can't change this overnight. 
But companies have told me that when they request a pre-
submission meeting, it may take months before they're able to 
meet with the FDA, and this may be a discussion point in some 
of the MDUFA negotiations.
    I'm wondering if and how FDA can speed this up now? In 
other words, can FDA meet with these companies sooner rather 
than later, to ensure they are complying with FDA's 
requirements at the beginning of this process, rather than in 
the middle?
    Dr. Shuren. We've been looking at what we can do to improve 
the pre-submission meetings. I will tell you that the requests 
for these meetings have essentially doubled in the past 5 
years. So, it's really outstripping our ability to meet the 
demand, if you will. And yet, we realize how helpful those 
meetings are. So, you're quite right that as a part of user fee 
reauthorization, we've been talking about making sure we have 
the ability to hold more timely meetings, to hold more 
meetings.
    But, the other piece of it is to make sure those meetings 
provide the maximum value. So, we are finalizing on policy, on 
expectations that companies can have of these meetings. And 
what we'll say in that document is, ``here are things we'd like 
to see from you,'' so we can have a well-informed meeting.
    The second is what you can expect from us. That if we're 
giving advice, then we should write it down, and we should 
stand behind it. Unless circumstances really change that you 
can't do so. You bring us a device, and you say it's for 
indication X, and you change later on what you're going to use 
the device for. Well, maybe our advice changes.
    But, in many other cases, it wouldn't and it shouldn't, and 
so, we're going to make those improvements. Namely, we're going 
to make the improvements we can with the resources we have, 
regardless of what happens. But, hopefully, we will work things 
out in user fee reauthorization that will have the ability to 
hold more and more timely pre-submission meetings. And I think 
that becomes a win for industry, and it becomes a win for us.
    Senator Hagan. When you stated that you wanted to be sure 
those meetings are valuable, well, in order for them to be 
valuable, they do have to take place. I certainly do agree, and 
anything we can do to speed that up. And I do think that 
industry recognizes that delays costs them money. So, I think 
for user fees, that they are definitely willing to pay upfront 
in order to have the availability of the FDA to meet them early 
on.
    I had a question about, and I know we've also spoken about 
this, but I wanted to reiterate that I've heard concerns with 
FDA's proposal to regulate the laboratory diagnostic test as 
medical devices. I'm concerned that duplicative regulation 
could slow innovation, impeding improvements to patient care as 
well as the job growth that has come from this innovation 
around this industry. And I understand that FDA may be close to 
releasing guidance to regulate the laboratory-developed tests 
as medical devices. Can you tell me what the status of this 
guidance is?
    Dr. Shuren. Certainly. That framework is currently under 
review by the administration.
    Senator Hagan. What's your timeframe?
    Dr. Shuren. That's not going to be my call.
    Senator Hagan. Can you share with us what that is?
    Dr. Shuren. I don't know. Because, it's currently under 
administration clearance. So, I don't know when they'll wind up 
making a decision.
    I will say, we have been consistent all along in saying 
that laboratory-developed tests for medical devices, they are 
tests just like what's made by a traditional manufacturer. And 
if we're out with a framework, our intent is not to duplicate 
existing requirements on laboratories.
    Senator Hagan. I think that's critical.
    Dr. Shuren. Yes.
    Senator Hagan. Thank you, Mr. Chairman.
    Senator Franken. Just one question. I've heard from large 
and small companies in my State that your guidance relating to 
the modifications of the 510(k) process for devices is of 
concern. Specifically, they are concerned that the new draft 
guidance that you release does not provide adequate clarity on 
when a new 510(k) submission is necessary for a modified 
device. The companies are telling me that the Center of Devices 
and Radiological Health may have greatly underestimated the 
increased workload from the proposed changes that could 
seriously delay the review process.
    Given that the stated goal of reforming the 510(k) process 
was to bring more clarity and efficiency to the processes, 
these reports are concerning. How would you respond?
    Dr. Shuren. We've heard the same concerns, and our intent 
in putting out this guidance was not about seeing some big 
increase in the number of 510(k)'s being submitted to us. We 
put out the guidance because a manufacturer can make some 
changes to a device, and they don't have to come back to the 
FDA. Now, where that line is crossed is not always clear.
    We've run into cases where manufacturers make changes. They 
should've come to us, they didn't. And those circumstances, 
it's very disruptive for the company, it's not good for 
patients. So, the more clarity we can provide, the better. And 
we're seeing new emerging technologies, and we wanted to 
provide clarity in that space.
    We've heard from companies, though, the policy we put out 
would wind up leading to many more 510(k)'s being submitted. So 
what we asked industry to do is, and we've got a number of 
groups working on this, is to go back with individual companies 
and apply. You know, say, ``here's how I interpret it, here's 
how we view the impact. Give that back to us so we can go 
through it, because our intent is to get this policy right.'' 
It's one of the reasons, too, why we've extended the time for 
getting feedback on this guidance, because we want to make sure 
we work with industry, we get the right policy in place.
    Senator Franken. Thank you.
    The Chairman. Dr. Shuren, thank you very much. I'll just 
close this by saying, the committee--again, the IOM report, in 
which I place a lot of stock, I think we all have to because it 
is unbiased, and they don't have to answer to anyone except 
their own, their own guidance as professionals. They said here, 
``The FDA has procedures for developing, adopting and 
implementing guidance and standards. The agency, however, is 
persistently hindered in fully developing these materials by a 
lack of, or limitations on human, fiscal and technologic 
resources and capabilities,'' which is getting to what Senator 
Mikulski was saying.
    More and more is required of FDA in this area as in other 
areas, and yet we continually cut the budget, cut the resources 
from the Federal Government to the FDA. At the same time, the 
companies that come in, as you said, we've had this huge 
increase in the applications for 510(k)'s in the last few 
years, and yet, as we cut the things down, more and more 
pressures are put on you since you can't do your job, well, 
then, we must make it easier. Because we want innovation, we 
want companies to succeed for all those business reasons. I 
don't think that's adequate. I don't think that suffices.
    I think that we need to understand that the first 
obligation you have is for the safety of patients, not whether 
or not a company gets the approval in a timely manner, or 
whether it makes a profit or not--your first is safety, and 
effectiveness, safety and effectiveness. We'll leave it up to 
CMS to talk about whether it's cost effective or not, that's 
not in your realm, that's in a different realm.
    And, so, it seems to me that you see the difference here in 
drugs, because we're also kind of playing the reauthorizing of 
the Prescription Drug User Fee Act also.
    Pharmaceutical companies now pay $1.8 million for a drug 
application. Devices pay, what did you say, $4,000?
    Dr. Shuren. Four thousand for a 510(k), the equivalent of 
the new drug application. It's a premarket approval 
application. That is $220,000, so about \1/9\th of what you 
pay.
    The Chairman. About \1/9\th of what that would be.
    Dr. Shuren. Right.
    The Chairman. So, it seems to me, I know that you're 
undergoing some conversations now, with the industry, on this, 
on user fees. But, I would just say this as the Chairman of 
this committee, that if we want better results from the FDA, 
more timely results and more transparency, and all the things 
that the IOM suggested we do, and we want to continue the 
510(k) process, which they had said we shouldn't, we should 
come up with a new regime, and perhaps we'll be looking at 
that--then it seems to me that the industry is going to have to 
come up with just a little bit more resources to help the FDA 
do its job.
    Thank you very much, Dr. Shuren. We'll move to our second 
panel.
    Dr. Shuren. Thank you.
    The Chairman. And we have on our second panel----
    Senator Franken. Would you like me to----
    The Chairman. Yes. I have the first one will be introduced 
first by Senator Franken from Minnesota.
    Senator Franken. As the witnesses take their places, I'm 
very pleased to introduce one of them. And that would be 
Professor Ralph Hall from my home State of Minnesota.
    Professor Hall is a member of the faculty at the University 
of Minnesota Law School, where he teaches courses on food and 
drug law, as well as corporate compliance and negotiations. As 
an expert in medical device regulation, Mr. Hall is also the 
CEO of a small medical device company in Minnesota. And he also 
serves as counsel to the law firm of Baker and Daniels. With 
several decades of experience working with the FDA, Professor 
Hall has an understanding of the strengths of FDA's regulatory 
processes, as well as a clear view of the areas where it could 
be improved.
    And thank you very much for joining us, Professor Hall.
    The Chairman. Thank you, Senator Franken. Our next witness 
up is Dr. David Challoner who is vice president emeritus for 
Health Affairs at the University of Florida. His clinical 
specialty is in internal medicine with a sub-special interest 
in endocrinology.
    He has previously served as Dean and Professor of Medicine 
at St. Luke's University School of Medicine. And from 1988 to 
1990, following an appointment by President Reagan, he was 
chair of the President's Committee on the National Medal of 
Science.
    Significantly, for today's discussion, Dr. Challoner 
chaired the IOM Committee that evaluated FDA's 510(k) review 
process and issued the report that I mentioned earlier, this 
past July.
    Our third panelist, Dr. Gregory F. Curfman, who is 
executive editor of the New England Journal of Medicine and 
assistant professor of medicine at Harvard Medical School. Dr. 
Curfman also practices cardiology and internal medicine at 
Massachusetts General Hospital. He graduated from Harvard 
University Medical School in 1972. He's published numerous 
articles on FDA issues; particularly in the area of medical 
device regulation.
    We thank you all for being here today. All of your 
statements will be made a part of the record in their entirety. 
I'm going to ask you to sum it up in about 5 minutes or so, and 
we'll go from left to right, just as I introduced everyone.
    So, Dr. Hall, Professor Hall, I guess I should say. Oh, you 
have a J.D., that's a Doctor too, what the heck?
    Mr. Hall. That's what they tell me.
    The Chairman. You're first up. Please proceed.

STATEMENT OF RALPH F. HALL, B.A., J.D., PROFESSOR OF PRACTICE, 
      UNIVERSITY OF MINNESOTA LAW SCHOOL, MINNEAPOLIS, MN

    Mr. Hall. Thank you, Senator Franken, for the kind 
invitation. Chairman Harkin, members of the committee, I 
appreciate the option to come and discuss with you the medical 
device regulatory system. My disclosures are in the written 
materials. I need to be clear that I'm speaking on my behalf, 
and I don't speak for any other organization or individual, so 
these are my personal views.
    My comments are going to focus on how the medical device 
system currently addresses safety and effectiveness. I want to 
start with three broad points.
    The system has changed substantially over the roughly 35 
years of its existence, as Congress has continuously worked to 
improve the system, as has FDA. That means that we need to look 
at the system as it exists today, not how it existed, perhaps 
20 or 30 years ago.
    I think it's also important to recognize that drugs and 
devices present very different regulatory challenges, and what 
is appropriate for one realm is not necessarily the right 
answer for others. Drugs, universally, have a potential 
systemic effect. Most devices do not. Many devices are tools, 
not the therapy itself, and tools present, then again, 
different regulatory needs and regulatory challenges. Devices 
operate and are improved in an iterative process with very 
short product lifecycles.
    Clinical trial issues between drugs and devices are also 
very different. In the drug world, the gold standard are the 
double-blind placebo-controlled studies. In many cases, in the 
device world, those studies simply are not appropriate. How 
does one do a double-blind placebo controlled study on a heart 
valve? You can't really cut somebody open, pretend to put in a 
heart valve, sew them up and see if it works?
    So, we need different mechanisms here. In the device world, 
there's a greater importance, generally speaking, of 
engineering, design, material sciences--those types of hard 
sciences.
    And, finally, as everyone has commented, there is a need 
here to balance safety, preventing risk with the benefits of 
access, particularly to innovative new products.
    Devices present a broad range of risk, from implantable 
neuro-modulators to crutches, and there, we have three systems 
to address those. But it's critical to recognize that each of 
the classifications, are to provide a reasonable assurance of 
safety and effectiveness. We differ in how that's achieved, not 
in the fundamental objective.
    Class I, simple devices--those are general controls, 
quality systems; class II, the 510(k), I'll get into this in a 
bit more detail use a variety of systems, including general 
controls, special controls, and the 510(k) system; class III 
products used a PMA. Within the 510(k) system, we actually have 
three major pathways or approaches to provide the reasonable 
assurance.
    First of all, the 510(k) premarket system is not simply a 
physical comparison of one device with another. It's much 
broader than that. We start with a classification process by 
which, before the first one is reviewed, FDA in conjunction 
with experts, makes a risk-based safety and efficacy-based 
decision as to the appropriate classification. Which class best 
provides a reasonable assurance? That's subject to 
reclassification, depending upon new information.
    Then, there are general controls, I mentioned, and special 
controls. Special controls are product-type specific. These can 
include clinical data, registries, performance standards, data 
testing requirements, design requirements, materials 
requirements all designed to ensure that there's this 
reasonable assurance of safe and effectiveness.
    There's then the process of comparing the product, the new 
product, with the predicate, the old product--and that looks 
at, from other things, the track record of the product. Safety 
effectiveness data is available to the agency on those 
products.
    If there's any new intended use, or a change in technology, 
and technology is defined very broadly, new safety and efficacy 
information has to be provided.
    Second, there are quality systems, these include design 
controls, postmarket surveillance, looking at product trends, 
iterative designs, etc.
    And finally, there are other regulatory systems to ensure 
the products are safe. For example, here a product is 
misbranded, if you can't label it for safe and effective use.
    Congress did not create, and the agency is not implementing 
a system by which the agency has no choice but to approve an 
unsafe product. Data from multiple source indicate that most 
devices, the vast majority, are safe, and the area of greatest 
improvement is in the quality system--that's work I've done, 
Dr. Maisel, IOM's conclusions, and also a recent FDA report.
    In conclusion, the FDA uses the 510(k) system to provide a 
reasonable assurance of safety and effectiveness. There are 
multiple tools that exist within this system to ensure that 
those standards are reached.
    I'll be pleased to answer questions at the appropriate 
time. Thank you.
    [The prepared statement of Mr. Hall follows:]
            Prepared Statement of Ralph F. Hall, B.A., J.D.
                                summary
A Critical Balance: FDA and the Reform of the Medical Device Approval 
        Process
    There are several key points that one should keep in mind in 
assessing the current medical device regulatory system.
    First, drugs and devices present very different regulatory issues. 
What works well in one system may not be appropriate or effective in 
the other arena.
    Second, the system created by Congress and implemented by FDA is 
intended to provide a reasonable assurance of safety and effectiveness 
for all products, regardless of classification. The means or method by 
which this is accomplished varies between Class I, II and III devices 
but the objective of safety and effectiveness does not. Class I uses 
``general controls'' to provide this assurance, Class II uses special 
controls, general controls and the 510(k) system to provide this 
assurance of safety and effectiveness. Class III uses the PMA process. 
These are different means to achieve the same safety objective.
    Next, the current 510(k) system gives FDA substantial authority to 
clear only products with a reasonable assurance of safety and 
effectiveness. FDA has multiple tools within the Class II/510(k) system 
beginning with initial product classification and extending through 
special controls and data submission requirements to assess product 
safety and effectiveness. FDA is not forced to clear a product just 
because it is physically identical to an older ``predicate'' product.
    Finally, and perhaps most importantly, available data demonstrates 
that the system is working well from a safety perspective. Overall, 
products approved or cleared by FDA, including 510(k) products, have 
very good safety records. Of course, all stakeholders should always be 
striving to improve on this already good record. Improvements in QSR 
(quality systems) offer the greatest potential patient benefit.
                                 ______
                                 
    Good afternoon, my name is Ralph F. Hall. I appreciate this 
opportunity to speak to this committee on these important medical 
device matters affecting patients, physicians, innovation and jobs. I 
am here to provide an overview of the medical device regulatory system, 
with particular focus on how the medical device regulatory system 
assesses product safety and effectiveness. In addition, I will discuss 
research I and others have done into the safety of 510(k) products.
    I want to be clear that I am here speaking in my personal capacity 
and not on behalf of the University of Minnesota or any other entity.
                       background and disclosures
    To start, I serve as Professor of Practitioner at the University of 
Minnesota Law School where I concentrate my teaching, research and 
writing in the area of FDA law and compliance matters. In addition, I 
am part time Counsel at the law firm of Baker & Daniels where I work 
with clients on a variety of FDA matters and also provide counsel to a 
national 510(k) coalition. Finally, I serve as CEO at MR3 Medical LLC--
a four person startup medical device company working on a new 
technology for cardiac rhythm devices generally regulated under the PMA 
process.
I. Medical Device Regulatory Overview
            a. Medical Devices are Significantly Different Than Drugs
    Many commentators simply compare drug regulation and device 
regulation. When differences between these systems appear, as they do, 
these commentators assume that there is some problem. It is absolutely 
critical to understand that there are important differences between 
drugs and devices that mandate some different regulatory approaches. 
These differences include:

     Drugs have a systematic effect on the body. A 
cardiovascular drug, for example, will also circulate throughout the 
body and potentially impact the liver, kidneys, muscles, lung, brain, 
etc. The vast majority of all devices do not have any systemic effect. 
Thus testing issues and needs are fundamentally different between drugs 
and devices.
     Medical device development is an iterative process with 
substantially shorter life cycles. That is not the case with drugs. 
Drug life cycles cover several decades while device life cycles are 
often measured in months. Also, drugs do not have the iterative 
development process found in devices. Any molecular change in a drug 
creates a new molecule and a whole new set of issues and questions. 
Most iterative changes to a device (making a catheter longer, for 
example) do not create new therapeutic issues.
     Essentially all drugs are the actual therapy. Many devices 
are actually a tool by which a physician delivers therapy, not the 
therapy itself. For example, a scalpel is a tool by which a medical 
intervention is performed. In such cases, FDA primary focus should be 
on whether the tool is performing as required, not whether the therapy 
such as an appendectomy (a physician decision) is effective.
     Engineering, design controls, human factors and material 
sciences are much more important to devices than to drugs. As detailed 
below, most postmarket safety issues with medical devices involve 
engineering, design, materials and manufacturing issues, problems not 
discoverable through clinical risks. Available data indicates that this 
is a different pattern from drugs. This difference in risk should 
impact premarket requirements.
     Devices span a much greater risk profile than drugs. While 
essentially all drugs pose some systemic questions that is not the case 
with devices. There is a world of difference between the risk/benefit 
of an implantable neuromodulator and that of a crutch. This huge risk 
spectrum mandates phased regulation of medical devices.
     There is incredible product differentiation within medical 
devices. Medical devices include diagnostic tools that never touch a 
patient, multimillion dollar pieces of capital equipment such as CT 
scanners, simple tools like a scalpel or bandaid and complex 
implantable devices such as an ICD.
     Device regulation includes robust and broad quality system 
requirements (often referred to as QSR requirements).

    The overall impact of these differences is that device regulation 
needs different premarket requirements, a risk-based approach to 
regulation and an emphasis on quality systems.
            b. Device Regulatory Overview
    By statute and regulation, all medical devices, regardless of risk 
classification, are to have a ``reasonable assurance of . . . safety 
and effectiveness'' before they are marketed.\1\ What differs is the 
method by which FDA and other stakeholders assess whether there is such 
assurance of safety and effectiveness for different classes of 
device.\2\ These different ways to provide this assurance of safety and 
effectiveness and the complex language and statutory systems for 
medical device regulation can lead to inadvertent confusion and 
misunderstanding. However, all products of whatever risk classification 
must provide this reasonable assurance of safety and effectiveness.\3\
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    \1\ 21 U.S.C.  393(b)(2)(C).
    \2\ It goes without saying that all therapeutic products have some 
risks. The objective is to ensure a positive risk/benefit for each 
product.
    \3\ Ensuring patient access to beneficial products is also 
critical. As such, FDA is also charged with promoting product 
innovation. While the focus of my comments is on the safety aspects of 
the device regulatory system, one cannot forget the importance of 
making innovative products available to physicians and patients.
---------------------------------------------------------------------------
    Because medical devices differ so much--from a tongue depressor to 
a multimillion dollar robotic surgical system--one regulatory approach 
does not fit all. To address this, Congress created a three-tier 
regulatory structure.

     Class I devices are the simplest, lowest risk devices. 
These include crutches, tongue depressors and scalpels. These products 
usually do not go through a premarket review and are generally referred 
to as Class I exempt.
     Class II devices are medium risk products such as 
angioplasty catheters. Class II devices generally go through the 510(k) 
system.
     Class III devices are the highest risk devices and include 
heart values and pacemakers. These products reach market through the 
PMA process.\4\
---------------------------------------------------------------------------
    \4\ This is a general description. Some higher risk Class I devices 
must go through the 510(k) system and some higher risk Class II 
products require a PMA. There are also some other pathways to market 
including the HDE process and the rarely used PDP system. For our 
purposes these alternative pathways are not relevant.

    Each device class, with some overlaps, uses a different method to 
provide assurances of safety and effectiveness.
    Class I products are those for which ``general controls'' are 
``sufficient to provide reasonable assurance of the safety and 
effectiveness of the device''.\5\ General controls can include, as 
appropriate, manufacturing controls, labeling, quality systems, etc.
---------------------------------------------------------------------------
    \5\ 21 U.S.C.  360c(a)(1)(A)(i).
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    Class II products are those for which general controls by 
themselves are not sufficient but for which ``special controls'' do 
provide a reasonable assurance of safety and effectiveness. These 
products use a different, multipronged system to provide the reasonable 
assurance of safety and effectiveness. Specifically, Congress provided 
that a Class II device is:

          A device which cannot be classified as a Class I device 
        because the general controls by themselves are insufficient to 
        provide reasonable assurance of the safety and effectiveness of 
        the device, and for which there is sufficient information to 
        establish special controls to provide such assurance [of safety 
        and effectiveness], including the promulgation of performance 
        standards, postmarket surveillance, patient registries, 
        development and dissemination of guidelines (including 
        guidelines for the submission of clinical data in premarket 
        notification submissions in accordance with section 510(k)), 
        recommendations, and other appropriate actions as the Secretary 
        deems necessary to provide such assurance.\6\
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    \6\ 21 U.S.C.  360c(a)(1)(B).

    As mandated by Congress, Class II devices generally must receive 
clearance under the 510(k) system described in more detail below and as 
part of that process must satisfy both special controls and general 
controls. 510(k) submissions can include clinical data, bench testing, 
labeling, reports on prior investigations, etc.
    The 510(k) system (described in more detail below) generally 
requires a product to establish that it is ``substantially equivalent'' 
to a predicate 510(k) device. Substantial equivalence is more than a 
physical comparison of one device to another. 510(k) products must also 
meet all special controls, all applicable standards and QSR 
requirements. FDA has the authority under the 510(k) system to request 
a wide variety of data, including clinical data, bench testing, 
proposed labeling, and material information, as part of its review of a 
510(k) submission.\7\ This submission explicitly includes a variety of 
safety and effectiveness information.\8\
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    \7\ 21 CFR  807.87, .90, .92 and .93 set forth more details about 
the content and format of a 510(k) submission.
    \8\ See, for example, 21 CFR  807.92(c)(3).
---------------------------------------------------------------------------
    Class III products must go through the PMA process.\9\ This often 
includes clinical testing and submissions include detailed 
manufacturing information, labeling, bench test data, etc. FDA reviews 
this data for safety and effectiveness.
---------------------------------------------------------------------------
    \9\ 21 U.S.C.  360e.
---------------------------------------------------------------------------
    It is important to understand that there are a number of other 
systems that also impose safety and effectiveness controls on products 
as part of an integrated system to provide a reasonable assurance of 
safety and effectiveness. For example, the QSR system \10\ requires 
design controls to help ensure a safe and effective design. There are 
also product and adverse event trending requirements, reporting 
requirements, etc. In addition, FDA has the authority to require 
postmarket testing on higher risk devices (including specifically Class 
II/510(k) products).\11\ There are also general labeling requirements 
including 21 U.S.C.  352(f) which mandates that a product labeling 
include ``adequate directions'' for safe use.
---------------------------------------------------------------------------
    \10\ QSR requirements are generally found in 21 CFR  820.
    \11\ 21 U.S.C.  360l. 21 U.S.C.  360l(a)(1)(A) explicitly 
includes Class II devices within the group of products subject to so-
called ``522 orders.''
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II. The 510(k) System Includes Safety and Effectiveness Considerations
    The 510(k) system has been the focus of recent attention. The 
510(k) system does consider safety and effectiveness. Stated 
differently, current FDA authority gives the agency multiple pathways 
to keep an unsafe 510(k) product off the market, require whatever 
testing or data is needed to establish safety and effectiveness and 
remove unsafe products from the market.
    From the beginning, Congress intended for the 510(k) system (and 
the substantial equivalence part of that process) to include safety and 
effectiveness determinations. As FDA itself explained to the IOM 
committee in March 2010, Congress intended the 510(k) substantial 
equivalence standard to be flexible in order to assure safety and 
effectiveness. The 510(k) legislative history states:

        The [congressional] committee believes that the term 
        [substantial equivalence] should be construed narrowly where 
        necessary to assure the safety and effectiveness of a device 
        but not narrowly where differences between a new device and a 
        marketed device do not relate to safety and effectiveness.\12\
---------------------------------------------------------------------------
    \12\ See FDA's presentation to IOM available at http://www.iom.edu/
Activities/PublicHealth/510KProcess/2010-MAR-01.aspx.

    Note the specific linkage of the substantial equivalence 
determination to safety and effectiveness.
    In order to see how the Class II/510(k) system ensures an 
assessment of safety and effectiveness, one must understand the process 
from the start. The 510(k) process actually begins before the first 
product is reviewed. By statute, FDA is obligated to classify each 
product type into Class I, II, or III. This classification process 
includes expert advisory panels, assessment of data and an opportunity 
for stakeholder input.\13\ The purpose of the classification process is 
to determine which oversight system is best positioned to provide 
assurances of safety and effectiveness. The product classification is 
based on safety and effectiveness considerations as confirmed by the 
implementing regulation which states:
---------------------------------------------------------------------------
    \13\ 21 U.S.C.  360c(c) and (d).

        (b) In determining the safety and effectiveness of a device for 
        purposes of classification, establishment of performance 
        standards for Class II devices, and premarket approval of Class 
        III devices, the Commissioner and the classification panels 
---------------------------------------------------------------------------
        will consider the following, among other relevant factors:

                (1) The persons for whose use the device is represented 
                or intended;
                (2) The conditions of use for the device, including 
                conditions of use prescribed, recommended, or suggested 
                in the labeling or advertising of the device, and other 
                intended conditions of use;
                (3) The probable benefit to health from the use of the 
                device weighed against any probable injury or illness 
                from such use; and
                (4) The reliability of the device (emphasis added).\14\
---------------------------------------------------------------------------
    \14\ 21 CFR  860.7(b).

    Further, by statute, if a product is implantable or is used to 
support or sustain human life, the default classification is Class III/
PMA unless the agency and classification panel specifically determine 
that the Class II/510(k) process is sufficiently robust and that Class 
III/PMA systems are not necessary to provide reasonable assurance of 
safety.\15\ Thus, before any device is even eligible for 510(k) review, 
FDA, in concert with expert classification panels, has made a 
determination that the Class II/510(k) system provides an adequate 
assurance of safety and effectiveness for that product type.\16\ 
Therefore, every 510(k) product type has been assessed and it has been 
determined that the 510(k) system provides the adequate assurance of 
safety and effectiveness.
---------------------------------------------------------------------------
    \15\ 21 U.S.C.  360c(c)(2)(C).
    \16\ As GAO and a number of commentators have noted, FDA is 
delinquent in classifying 26 out of, I believe, approximately 1,800 
product types. These products continue to be reviewed under the 510(k) 
system. FDA is currently in process of rectifying this situation and 
completing the classification of these remaining products.
---------------------------------------------------------------------------
    Once classified, the 510(k) system uses the concept of 
``substantial equivalence'' as a method to assess safety and 
effectiveness.\17\ The policy behind the 510(k) system is that once it 
has been determined that a product type is safe and effective for its 
intended use, future products that are ``substantially equivalent'' to 
the initial product and which meet all other regulatory requirements 
are likewise safe and effective. Substantial equivalence is more than a 
physical comparison of one product to another.
---------------------------------------------------------------------------
    \17\ In reviewing 21 U.S.C.  360c--the key statutory section 
relating to Class II/510(k) devices--one can see that Congress used the 
term ``safety'' with regard to Class II/510(k) products more than 17 
times by my count. One can only wonder why Congress would discuss 
safety so many times unless Congress intended for the 510(k) to 
consider safety and effectiveness.
---------------------------------------------------------------------------
    The 510(k) submission provides the information to FDA by which it 
can determine that the safety profile of the new product meets the 
established safety profile of the prior (or predicate) device, all 
special controls or similar requirements have been met and that the 
product is otherwise safe and effective for its intended use. The 
submission specifically includes safety information.
    For example, 21 CFR  807.92(c)(3) states that a 510(k) summary 
must include:

          The conclusions drawn from the nonclinical and clinical tests 
        that demonstrate that the device is as safe, as effective, and 
        performs as well as or better than [the predicate device].

    21 U.S.C.  360c(i)(3)(A) requires a 510(k) submission to include 
adequate information respecting the safety and effectiveness of the 
device and/or to make that information available. Under 21 U.S.C.  
360c(i)(3)(B), this summary shall include detailed information 
regarding adverse health effects relating to the product and this 
information shall be made available to the public.\18\
---------------------------------------------------------------------------
    \18\ One is hard pressed to argue that Congress intended FDA to 
have this safety and effectiveness information and then mandated that 
FDA ignore that data in making 510(k) clearance decisions.
---------------------------------------------------------------------------
    In addition to data submission requirements, Congress has given FDA 
another powerful tool to ensure product safety and effectiveness. The 
510(k) system makes explicit use of ``special controls'' to ensure 
safety and effectiveness and any 510(k) product must satisfy all 
special control requirements. Under 21 U.S.C.  360c(a)(1)(B), special 
controls are explicitly used to provide a reasonable assurance of 
safety and effectiveness. Special controls can include clinical data 
requirements, performance standards, patient registries, guidance 
documents, etc. Any new product must comply with all applicable special 
controls. These special controls are used in addition to physical 
identicality to establish safety and effectiveness.
    Products can and usually do evolve over time. The ``substantial 
equivalence'' process is designed to subject any new product use or 
technology to an explicit safety and effectiveness review. Congress 
specifically required FDA to assess new intended uses and new 
technologies for safety and effectiveness.\19\
---------------------------------------------------------------------------
    \19\ 21 U.S.C.  360c(i)(1). Note that new technology is broadly 
defined to ensure that product changes are reviewed for safety and 
effectiveness. 21 U.S.C.  360c(i)(1)(B).
---------------------------------------------------------------------------
    There is, of course, the concern that changing information or new 
data may call into question prior classification decisions or special 
controls. Congress anticipated this concern and explicitly established 
reclassification processes under 21 U.S.C.  360c(e) that FDA can use 
(and any stakeholder can request) in the event of new information. This 
reclassification process can address any new information and either up 
classify or down classify a device type as the data directs. Any down 
classification from Class III to Class II requires a determination that 
Class II special controls provide a reasonable assurance of safety and 
effectiveness. Likewise, FDA can create new or enhanced special 
controls under 21 U.S.C.  360c(a)(1(B) to address new safety or 
effectiveness issues.
    Congress has provided FDA with other tools to ensure that an unsafe 
Class II product does not reach the market. For example, FDA has the 
authority to ban unsafe devices,\20\ and ensure that the product 
labeling permits safe use.\21\ Any product that has been removed from 
the market ``at the imitative'' of FDA or has been found to be 
misbranded or adulterated by a court cannot be used as a predicate to a 
later product.\22\ This is one method by which a ``bad'' predicate 
cannot be used for future products. Other tools include the ability to 
develop new or enhanced special controls and to require additional data 
to be submitted.
---------------------------------------------------------------------------
    \20\ 21 U.S.C.  360f(a).
    \21\ 21 U.S.C.  352(f). Even if a product is ``substantially 
equivalent'' to another, if it cannot be labeled so that it can be used 
safely, the product is misbranded and distribution of such a product 
triggers civil and criminal liability.
    \22\ 21 U.S.C.  360c(i)(2).
---------------------------------------------------------------------------
    While the term ``substantial equivalence'' can sound like merely a 
physical comparison of one product to another, an understanding of the 
overall 510(k) system demonstrates that much more than physical 
identity is needed to be cleared for marketing. Before a product can be 
deemed to be ``substantially equivalent'' and the product legally 
marketed the system requires, among other requirements:

     Product classification into the 510(k) system based on 
safety and effectiveness assessments.
     Compliance with special controls explicitly intended to 
provide assurances of safety and effectiveness.
     Compliance with all applicable standards and guidances.
     Assessment of any new intended uses or new technology for 
safety and effectiveness.
     Submission of safety and effectiveness data and adverse 
health information.
     Compliance with all applicable general controls.
     Compliance with QSR requirements.

    As such, FDA has multiple avenues to assess and address any safety 
or effectiveness issues.
III. Key Examples
    I will now apply the 510(k) system to the three key product 
situations to demonstrate that, in each case, FDA has the authority to 
assess safety and effectiveness.
            a. The New Product
    There are situations in which a product is developed for which 
there is no predicate. Normally, these products are automatically, by 
application of statute, classified as PMA products.\23\ Unless there is 
an actual reclassification, these products go through the PMA process 
and so there is no question about the robustness of the 510(k) process.
---------------------------------------------------------------------------
    \23\ 21 U.S.C.  360c(f)(1).
---------------------------------------------------------------------------
    However, such a product may well be a medium risk product and so 
best regulated as a Class II/510(k) product. In these cases, the 
product can be classified as a Class II/510(k) product pursuant to the 
``de novo'' process under 21 U.S.C.  360c(f)(2). This classification 
process explicitly considers whether the product can be safely 
regulated under Class II systems including special controls.
    As such, no ``new'' product can be regulated under the 510(k) 
system unless FDA has made an explicit determination that the 510(k) 
system provides adequate assurances of safety and effectiveness.
            b. Changes to an ``Old'' Product
    The next fact pattern involves an existing product, already in the 
Class II/510(k) system, to which the company is making some change. 
This can be a new intended use or some change in technology. In each 
case, the change in the product must be explicitly assessed for safety 
and effectiveness.\24\ The product cannot be cleared if the product 
raises some new issue of safety or effectiveness.\25\
---------------------------------------------------------------------------
    \24\ 21 U.S.C.  360c(i) and 21 CFR  807.
    \25\ FDA's internal processes and flow charts reinforce the fact 
that any change in intended use or technology is assessed for safety 
and effectiveness. There is a ``not substantially equivalent'' 
(``NSE'') determination if there is some new question of safety or 
effectiveness.
---------------------------------------------------------------------------
    Remember that one of the core concepts of the 510(k) system is that 
once safety and effectiveness has been determined, like products can 
establish safety and effectiveness based on the prior assessment. Of 
course product changes can challenge this concept and so Congress as 
decreed and FDA has insisted that any change in the use of the product 
or the technology (broadly defined) must be assessed to ensure safety 
and effectiveness. Thus, Congress and FDA have assured that product 
iterations or changes will be assessed for safety and effectiveness.
            c. Continued Marketing of an ``Old'' Product
    The final challenge is the one that seemed to bother the IOM 
committee and others the most and this is the old product that hasn't 
changed.\26\ Some seem to believe that these ``old'' products have 
never been assessed for safety and effectiveness and that FDA is bound 
to clear any such product without considerations of any safety or 
effectiveness issues. This is simply not the case.
---------------------------------------------------------------------------
    \26\ This includes situations in which the old, unchanged, feature 
of the product presents some new safety or effectiveness issue.
---------------------------------------------------------------------------
    FDA has multiple authorities to keep an unsafe 510(k) product--even 
if literally identical to an old product--off the market.
    To start, all products have been assessed for safety and 
effectiveness issues through the classification process.\27\ Even if 
the product existed before 1976, it has been specifically assessed and 
a determination made that products of that type can be regulated under 
the Class II/510(k) system for safety and effectiveness.\28\ Just 
because a product was on the market before 1976 does not mean that it 
is part of the 510(k) system.
---------------------------------------------------------------------------
    \27\ I recognize that a few products (some number less than 26 out 
of approximately 1,800 product codes) have not completed this process. 
As many others have previously said, this process must be completed. 
FDA is currently in the process of doing so.
    \28\ See 21 U.S.C.  360c(c) and (d) and 21 CFR  807 and 860 for 
more details.
---------------------------------------------------------------------------
    The related question is what happens if new information is 
developed on an ``old'' product subsequent to its classification. 
First, FDA has access to such information through any number of 
sources. Importantly, Congress has decreed that the company must 
include adverse health information in its 510(k) submission.\29\
---------------------------------------------------------------------------
    \29\ 21 U.S.C.  360c(i)(3).
---------------------------------------------------------------------------
    Once such information comes to FDA's attention, FDA has any number 
of approaches to prevent an unsafe product from being cleared via the 
510(k) system. Examples of these tools include:

     Creating new or enhanced special controls to mitigate or 
eliminate the newly discovered risk.\30\
---------------------------------------------------------------------------
    \30\ 21 U.S.C.  360c(a)(1)(B).
---------------------------------------------------------------------------
     Reclassifying the device into Class III.\31\
---------------------------------------------------------------------------
    \31\ 21 U.S.C.  360c(e).
---------------------------------------------------------------------------
     Creating or adopting new guidances or standards.
     Requiring new labeling to mitigate or eliminate the issue 
(or concluding that such improved labeling would not be effective and 
thus the product is misbranded).\32\
---------------------------------------------------------------------------
    \32\ 21 U.S.C.  352(f).
---------------------------------------------------------------------------
     Imposing postmarket obligations.\33\
---------------------------------------------------------------------------
    \33\ 21 U.S.C.  360l.
---------------------------------------------------------------------------
     Banning the device.\34\
---------------------------------------------------------------------------
    \34\ 21 U.S.C.  360f.
---------------------------------------------------------------------------
     Utilizing QSR requirements to address the issue.\35\
---------------------------------------------------------------------------
    \35\ 21 CFR  820.

    Thus, each product type is reviewed for safety and effectiveness 
issues at the time of initial classification. Post classification, FDA 
has multiple statutory and regulatory authorities available to prevent 
an unsafe product from being cleared.
    Congress did not create--and FDA is not implementing--a regulatory 
system under which FDA has no choice but to clear an unsafe device.
IV. FDA in Fact Makes Safety and Effectiveness Determinations in 
        Product Clearances
    How the 510(k) system actually works is best demonstrated by 
looking at actual product clearances. In many cases, FDA specifically 
indicates in the clearance documents that the product in question is 
safe and effective for its intended uses.
    For example, Via Biomedical, Inc.'s Stent Graft Balloon Catheter 
has been determined substantially equivalent and cleared for market 
distribution.\36\ Included in the 510(k) summary was the following:
---------------------------------------------------------------------------
    \36\ 510K Summary from Via Biomedical, Inc., on the Stent Graft 
Balloon Catheter (May 29, 2009), http://www.accessdata.fda.gov/
cdrh_docs/pdf9/K091624.pdf.

          The Stent Graft Balloon Catheter underwent mechanical, 
        performance, and Biocompatibility testing to verify that the 
        device functions in a safe and effective manner. The results of 
        the tests provide reasonable assurance that the device has been 
        designed and tested to assure conformance to the requirements 
        for its indications for use.\37\ (emphasis added).
---------------------------------------------------------------------------
    \37\ Id. (emphasis added).

    Becton, Dickinson and Company's (Becton) BD Flu+ Syringe was 
cleared for market on July 2, 2009. As part of its submission, Becton 
expressly indicated that [d]esign [v]erification tests were performed 
based on the risk analysis performed, and the results of these tests 
demonstrate that the BD Flu+ Syringe performed in an equivalent manner 
to the predicate device and is safe and effective when used as 
intended. \38\
---------------------------------------------------------------------------
    \38\ 510K Summary of Safety and Effectiveness from Becton, 
Dickinson and Company on the BD Flu+ Syringe (Jul. 2, 2009), http://
www.accessdata.fda.gov/cdrh_docs/pdf9/K091377.pdf.
---------------------------------------------------------------------------
    Likewise ArthoCare's Bone Cement Opacifier was cleared under 510(k) 
after the FDA confirmed that the performance testing and device 
comparison demonstrated that the subject device [was] substantially 
equivalent to the predicate device, and is safe and effective for its 
intended use. \39\ (emphasis added).
---------------------------------------------------------------------------
    \39\ 510K Summary from Becton, Dickinson and Company on BD Flu+ 
Syringe, http://www.accessdata.fda.gov/cdrh_docs/pdf4/K042947.pdf. The 
device was not found to be as safe as the predicate, but there was an 
independent assessment. The device was both substantially equivalent to 
the predicate as well as safe and effective.
---------------------------------------------------------------------------
    There are numerous other examples of 510(k) submissions that have 
been included in the safety and effectiveness data and have been 
assessed by FDA for safety and effectiveness. A few examples include 
the Master Healthcare's Easy Touch Insulin Syringe,\40\ ZOLL 
Circulation's Central Venous Catheter and Thermal Regulating System 
\41\ and Medtronic's Cardiopulmonary Centrifugal Blood Pump.\42\ All of 
these submissions included performance data specifically relating to 
the safety and effectiveness of the device as part of the 510(k) 
clearance.
---------------------------------------------------------------------------
    \40\ 510K Summary from Masters Healthcare on the Easy Touch Insulin 
Syringe (May 14, 2009) http://www.accessdata.fda.gov/cdrh_docs/pdf9/
K091474.pdf.
    \41\ 510K Summary from ZOLL Circulation for Venous Catheter and 
Thermal Regulating System (Oct. 12, 2010), http://
www.accessdata.fda.gov/cdrh_docs/pdf10/K101987.pdf.
    \42\ Summary of Safety and Effectiveness from Medtronic for the 
Cardiopulmonary Centrifugal Blood Pump (Jun. 21, 2010), http://
www.accessdata.fda.gov/cdrh_docs/pdf10/K100631.pdf.
---------------------------------------------------------------------------
    As these and other examples demonstrate, FDA in fact considers 
safety and effectiveness in product decisions.
    Furthermore, in numerous presentations, guidance documents and 
public statements, FDA has said that the 510(k) system includes safety 
and effectiveness protections.
    In summary, it can be seen that products going through the 510(k) 
system are assessed for safety and effectiveness beginning with the 
initial classification process. FDA has a variety of tools including 
special controls to ensure product safety. Congress did not create a 
system by which literally thousands of devices have been cleared 
without protecting patient safety.
V. Medical Device Safety Study Summary
    The actual safety of medical devices is, of course, of prime 
importance to patients, physicians and other stakeholders.
    There have been several studies of medical device safety (or 
reasons for medical device problems) over the past 2 years. These 
include a study I have done (and presented to the IOM 510(k) 
committee), a study by Dr. William Maisel (also presented to the IOM 
510(k) committee) and a recent report by FDA itself.
    In my view, these studies, individually and together, support two 
key conclusions:

    (1) There is no evidence of any overall systemic issue with the 
safety of 510(k) products; and
    (2) The primary cause of medical device safety recalls are quality 
system issues, not a lack of premarket clinical testing. I will also 
note that the IOM 510(k) committee itself also found no evidence of a 
systemic issue with the safety of 510(k) products. The committee has 
explicitly stated: ``The committee is not suggesting that all, many, or 
even any medical devices cleared through the 510(k) process and 
currently on the market are unsafe or ineffective.'' \43\
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    \43\ See IOM report brief available at http://www.iom.edu/Reports/
2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-
Process-at-35-Years.aspx.

    My comments will focus on the study I performed assessing the 
overall safety profile of medical devices approved or cleared by FDA 
from 2005-9 by using Class I safety recall data. This research was 
funded by the Ewing Marion Kauffman Foundation, a private nonpartisan 
foundation based in Kansas City, MO. Their generous support made this 
research possible. The Kauffman Foundation has given me complete 
academic freedom to pursue this research.\44\
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    \44\ I want to thank Amanda Maccoux, Mark Jones, Chris Walker and 
Ron Song--the research assistants at the University of Minnesota Law 
School--who spent long hours doing the detailed data collection and 
coding required for this study. Their talents, hard work and dedication 
are vital to this research and I appreciate all that they did.
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    This study \45\ evaluated Class I (or high risk) recalls of all 
medical devices, regardless of whether they were approved through the 
PMA system, cleared through the 510(k) process or were otherwise 
exempt.
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    \45\ An earlier version of this research into the safety of medical 
devices through an analysis of safety recalls was presented to the 
Institute of Medicine committee reviewing the 510(k) system and 
reviewed with FDA.
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    The key conclusions from my research are as follows:

    (1) Overall, 510(k) regulated medical devices have an excellent 
safety profile. Over 99.5 percent of 510(k) submissions assessed during 
this study period did not result in a Class I safety recall. Over 99.7 
percent of 510(k) submissions did not result in a Class I recall for 
any reason relevant to the 510(k) premarket system.
    (2) Products approved through the PMA system also have an excellent 
safety record. Again, greater than 99.5 percent of PMA or sPMA 
submissions do not result in a Class I safety recall during the study 
period.
    (3) Very few (less than 9 percent), Class I recalls during the 
study period involve possible undiscovered clinical risks. As such, 
increased preapproval clinical testing would not have any meaningful 
impact on reducing the number of Class I recalls.
    (4) The majority (approximately 55 percent) of all Class I recalls 
involve problems or issues that arose after market release and could 
not be affected by premarket approval systems or requirements. For 
example, a manufacturing mistake made 3 years after FDA approval or 
clearance may trigger a Class I recall. However, any premarket 
requirements such as clinical testing are irrelevant to preventing such 
a recall.
    (5) A very significant majority (over 90 percent) of all Class I 
recalls (including both premarket and postmarket issues) are directly 
related to quality system issues (so-called QSR systems \46\). Improved 
QSR systems will have the greatest effect in reducing the number of 
Class I recalls.
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    \46\ QSR requirements are intended to provide ``cradle to grave'' 
product quality in a closed loop, learning system. QSRs include design 
input and processes, design validation, product testing, manufacturing 
controls, process controls, change controls, management review and 
postmarket assessments. See, generally, 21 CFR  820.
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    (6) My study did identify a bolus of Class I recalls in two device 
types--automatic external defibrillators (``AEDs'') and infusion pumps. 
Any changes to the premarket review process should be targeted to 
demonstrate problems rather than applied in some random, shotgun way.
    (7) Finally, one should not confuse classification for premarket 
review processes with recall classification. These are very different 
things and serve very different purposes.

VI. Study Background
    The need for the research that I will describe goes back several 
years when a number of stakeholders started to question the robustness 
of the 510(k) system. I was particularly struck by the fact that there 
was no good, objective data to support or refute the assertion that the 
510(k) system needed to be changed because of these presumed safety 
issues.
    Given my concerns over the lack of hard data, I commenced a study 
(with the able assistance of four research assistants) assessing the 
safety performance of FDA approval processes. To my knowledge, this was 
the first study designed to systemically assess the safety performance 
of the 510(k) system.
VII. Study Methodology
    This study assessed the overall safety profile of medical devices 
approved or cleared by FDA from 2005-9 by using Class I safety recall 
data.
    Class I safety recalls were chosen as the measure of safety as 
these recalls involve any medical device problem posing any significant 
risk of serious health consequences to patients and also correctly 
exclude risks considered as part of the approval or review process. 
Class II recalls involve generally remote risks to patients and Class 
III recalls involve minimal or no risk to patients. FDA, not industry, 
is responsible for assigning the recall classification.
    Note that the Class of recall assigned by FDA is independent of the 
product's device classification. For example, no one would argue that a 
tongue depressor is a high-risk device or needs a clinical trial. For 
premarket purposes it is classified as a low-risk, exempt device. 
However, if the tongue depressor gets contaminated with deadly bacteria 
because of product tampering or some manufacturing problem, there is a 
significant risk to patients. This would be a high-risk or Class I 
recall even though for premarket review purposes it is a low-risk 
device.
    Using FDA databases, we identified all Class I recalls posted by 
FDA on public databases during 2005-9. We first combined all duplicate 
recalls into one data set of unique or stand alone recalls. (FDA may 
have several recall announcements and thus there may be multiple data 
entries for the same issue because of different package configurations, 
brand names or product sizes).
    There were 118 unique recalls identified. We then coded each recall 
for a number of factors including regulatory pathway, medical 
specialty, whether implantable and three letter product code. We also 
coded each recall with 1 of 13 reasons for recalls. Generally speaking, 
these 13 recall reasons can be combined into three broad groupings of 
premarket issues (i.e., something that could, at least theoretically, 
have been discovered during a premarket review process), postmarket 
issues and miscellaneous (counterfeit and ``quack'' products). We used 
FDA Web sites and publicly available information for this coding.
    This study must be assessed in light of the following factors and 
limitations:

    (1) First, we relied entirely upon publicly available data. We did 
not identify any meaningful errors in this data but did not conduct any 
structured assessment of the accuracy of FDA's data.
    (2) Second, while companies are obligated to report recalls, there 
may be situations in which the company failed to meet this obligation. 
We believe that any such missing recalls would tend to be small and not 
common because of the penalties for non-compliance and the variety of 
information sources that would disclose any such recall. Importantly, 
there is no reason to believe that the distribution of the causes of 
such recalls would be different than the data we had.
    (3) Third, we reviewed Class I recalls and not Class II recalls. 
(FDA defines a Class II recall as a situation in which the problem 
might cause a temporary health problem, or pose only a slight threat of 
a serious nature.) We believe that Class I recalls represent all 
recalls with any meaningful risk to patients and so that represents a 
valid safety picture. Remember that Class II recalls are for remote 
risks or low impact problems. Class I recalls represent the majority of 
actual patient risk and tend to err in the direction of higher rather 
than lower classification. Risks as low as 1/20,000 have been 
classified as Class I recalls thus demonstrating the breadth of risks 
captured by Class I recalls.
    (4) Anecdotal review of some Class II recalls indicate (but does 
not establish) the same general pattern of reasons for recalls between 
Class I and Class II recalls.
    (5) Finally we did not assess any effects of various regulatory 
systems or actions on patient access to new products, innovation or the 
economy in general.
    We also determined the percentage of 510(k) submissions that 
resulted in a subsequent Class I recall. The numerator for this 
calculation is the number of recalls. The denominator is the number of 
submissions. The denominator for this calculation is a close estimate 
as there is no direct connection between the date of the submission and 
the subsequent recall. For example, a recall for a design defect might 
occur within a month after market release while a recall for a 
manufacturing error or packaging mistake could occur literally years 
after approval or clearance.
    We determined an annualized number of submissions by taking the 
average number of submissions for a 10-year period (2000-2009) and 
annualizing that number. We used this number for all percentage 
calculations. Those percentages, however, are approximations due to 
this data challenge.
VIII. Study Results and Data
    Initially, we looked at the reasons for recalls for these 118 Class 
I recalls. We determined the reason for the recall by examining FDA's 
public data bases and also reviewing publicly available information 
including physician notification letters and SEC filings. I was 
responsible for all decisions relating to the reason for recall. I 
blindly recoded 10 percent of the recalls and had a complete match with 
the initial determination of the reason for the recall.
    As shown below, the majority of all recalls (approximately 55 
percent) are for postmarket issues. For these recalls, no change in the 
premarket 510(k) or PMA process would affect the recall occurrence or 
frequency.


----------------------------------------------------------------------------------------------------------------
                                                                             Recalled                 Percent of
                                                    Total     Recalls for      for        Recalled    recalls to
                                                   recalls     premarket    postmarket   for other      total
                                                                 issues       issues       issues      recalls
----------------------------------------------------------------------------------------------------------------
Class I or.....................................            7            1            6            0
  u/k..........................................                   (14.2%)      (85.7%)         (0%)          5.9
510(k).........................................           95           43           46            6
                                                                  (45.3%)      (48.4%)       (6.3%)         80.5
PMA............................................           16            7            9            0
                                                                  (43.8%)      (56.3%)         (0%)        13.56
                                                ----------------------------------------------------------------
    Total......................................          118           51           61            6          118
----------------------------------------------------------------------------------------------------------------

    As seen below, a very small percentage of 510(k) submissions led to 
a Class I recall during our study period. The first chart shows the 
ratio of 510(k) submissions to all Class I recalls and the second chart 
shows the ratio of 510(k) submissions to Class I recalls related to any 
theoretical premarket issue.
    Based on this data, approximately 99.55 percent of all 510(k) 
submissions did not result in a Class I recall for any issue during the 
study period. More importantly for assessing the 510(k) process, 
approximately 99.78 percent of all 510(k) submissions did not result in 
a Class I recall for any reason related to the premarket process. 
Stated differently, the maximum theoretical impact of any change in the 
510(k) system would be on 0.22 percent of all 510(k) submissions. This 
data also demonstrates that additional premarket clinical testing would 
be ineffective in reducing Class I safety recalls.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

      
      


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

------------------------------------------------------------------------
Total 510(k) Submissions in 10 years.......................       39,747
Average Submissions in 5-year time period..................       19,873
Total 510(k) Recalls for 2005-2009.........................           89
Total 510(k) Recalls for Premarket Issues for 2005-2009....           43

    The number of recalls related to premarket issues is most relevant 
in assessing whether the 510(k) system is adequately addressing patient 
safety during the review process. This data demonstrates that 
postmarket issues, not premarket processes, should be the focus to 
improve patient safety.
    This conclusion is reinforced when we reviewed the role of quality 
systems in recalls. As shown below, over 90 percent of all Class I 
safety recalls are related to quality system issues and not to other 
factors such as a lack of clinical trials.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Clearly, this data demonstrates that all stakeholders should 
concentrate on QSR systems such as design control and bench testing--
not the 510(k) submission system--as the most effective way to provide 
greater patient safety.
    We also did sub-analysis by product type and medical specialty. 
Such analysis can be used to identify concentrations of issues for 
further investigation by FDA, industry and other stakeholders. As seen 
below, Class I recalls are concentrated in several product types.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                           medical specialty
    Further analysis indicated that automatic external defibrillators 
(AEDs) and infusion pumps accounted for 28 percent of all Class I 
recalls and accounted for a substantial part of the bolus or recalls 
seen in the cardiovascular and general hospital categories. Within the 
past 9 months, FDA has triggered new regulatory initiatives for both 
AEDs and infusion pumps.
    Our confidence in our study design and results has been bolstered 
by subsequent studies by others such as FDA itself, Dr. Maisel and 
Battelle finding very similar numbers and reasons for Class I recalls.
IX. Study Conclusion
    This study demonstrates that very few 510(k) medical device 
submissions--less than 0.5 percent--become the subject of a Class I 
safety recall. Even in this small number of Class I recalls, the 
majority of Class I recalls involve postmarket issues such as 
manufacturing mistakes, and are focused around two product categories 
(cardiovascular and general hospital). These recalls involve quality 
system issues, not premarket issues. Overall, in excess of 90 percent 
of all recalls appear to involve quality system issues.
    Our study shows that FDA has a very positive safety record in its 
510(k) clearance decisions.
X. Conclusion
    The current 510(k) system gives FDA substantial authority to clear 
only products with a reasonable assurance of safety and effectiveness. 
FDA has multiple tools beginning with initial product classification 
and extending through special controls and data submission requirements 
to assess product safety and effectiveness.
    Overall, products approved or cleared by FDA have very good safety 
records. Of course, all stakeholders should always be striving to 
improve on this already good record. Improvements in QSR (quality 
systems) offer the greatest potential patient benefit.
    Again, I appreciate the opportunity to present to the committee and 
would be happy to answer any questions.

   STATEMENT OF DAVID R. CHALLONER, M.D., VICE PRESIDENT FOR 
  HEALTH AFFAIRS, EMERITUS, UNIVERSITY OF FLORIDA AND CHAIR, 
COMMITTEE ON THE PUBLIC HEALTH EFFECTIVENESS OF THE FDA 510(K) 
   CLEARANCE PROCESS, INSTITUTE OF MEDICINE OF THE NATIONAL 
                   ACADEMIES, GAINESVILLE, FL

    Dr. Challoner. There we go, thank you.
    I'm vice president for Health Affairs Emeritus at the 
University of Florida, and I also served as chair at the 
Institute of Medicine in this committee on the public health 
effectiveness of the 510(k) clearance process.
    The IOM is the health arm of the National Academy of 
Sciences--an independent, non-profit organization that provides 
unbiased and authoritative advice to decisionmakers and the 
public.
    I am accompanied this afternoon by several members of the 
NRC and IOM staff, and by Mr. William Vodra, who was also a 
member of my committee.
    The IOM was asked by the FDA to review the 510(k) clearance 
process, and to answer two questions, as has already been 
pointed out. Does the current 510(k) process optimally protect 
patients, and promote innovation and support of public health? 
And if not, what legislative, regulatory or administrative 
changes are recommended to optimally achieve the goals of the 
510(k) process?
    The IOM assembled an expert committee of which I was 
chaired to address this task. The committee met in person 6 
times over an 11-month period to gather evidence, deliberate on 
its findings and recommendations, and write its report. That 
report, then, underwent a rigorous, independent, external 
review before being released in July of this year. More 
detailed information on the committee's findings and 
recommendations is included with my longer, written statement.
    The committee's task was challenging for several reasons--
devices regulated within the 510(k) process encompass a broad 
range of function, benefits, and risks. Also, the 510(k) 
process is not a standalone process, but is part of a larger 
regulatory system that is dependent upon all the components 
functioning optimally to ensure the public health. And finally, 
the 510(k) process was continuing to evolve as the committee 
was conducting its work.
    The committee evaluated legislative, regulatory and 
administrative components of the 510(k) process, and other 
related components of medical device regulation. We came to the 
conclusion that the 510(k) process, as outlined in law, 
generally does not evaluate the safety and effectiveness of a 
device, only the new device's similarity to a predicate.
    Furthermore, the 510(k) process cannot be transformed into 
a premarket evaluation of safety and effectiveness, as long as 
the standard for clearance is substantial equivalence to any 
previously cleared device.
    I want to emphasize that we believe the FDA has done an 
admirable job of protecting the public, given the constraints 
on its regulatory authorities, and limited resources, as we've 
heard discussed earlier today. The committee recognizes that 
replacing the 510(k) process will take some time, and that a 
substantial amount of information will need to be obtained to 
inform the design of a new framework.
    However, there are steps that FDA can take now to improve 
regulatory oversight of medical devices. The committee 
believes, strongly, that it is important that regulatory 
oversight of devices be conducted throughout their lifecycle.
    In its report, the committee makes eight recommendations 
geared toward using resources wisely to ensure both short-term 
and long-term benefits. Among the actions recommended by the 
committee are that the FDA strengthen its postmarketing 
surveillance program for devices, identify limitations in the 
use of its postmarket regulatory authorities, and to address 
them, and implement a program of continuous quality 
improvement.
    We understand that the FDA, on its own initiative, is 
already moving forward with making improvements to its 
postmarketing surveillance, and quality assurance programs. 
Ultimately, these changes will benefit patients, healthcare 
providers, the industry, and the FDA.
    Thank you very much for the opportunity to testify, and I 
will be happy to answer any questions later.
    [The prepared statement of Dr. Challoner follows:]
             Prepared Statement of David R. Challoner, M.D.
                                summary
    The Food and Drug Administration (FDA) asked the Institute of 
Medicine (IOM) to review the 510(k) clearance process for medical 
devices and to answer two questions:

    1. Does the current 510(k) process optimally protect patients and 
promote innovation in support of public health?
    2. If not, what legislative, regulatory, or administrative changes 
are recommended to optimally achieve the goals of the 510(k) process?

    An expert committee assembled by the IOM addressed that task in its 
report, Medical Devices and the Public's Health: The FDA 510(k) 
Clearance Process at 35 Years. The report was released in July 2011.
    On the basis of its review and evaluation of legislative, 
regulatory, and administrative components of the 510(k) process and 
other related components of medical-device regulation, the committee 
concluded that the 510(k) process in general is not intended to 
evaluate the safety and effectiveness of medical devices. Furthermore, 
the 510(k) process cannot be transformed into a premarket evaluation of 
safety and effectiveness as long as the standard for clearance is 
substantial equivalence to any previously cleared device.
    The committee recognizes that replacing the 510(k) process will 
take some time and that a substantial amount of information will need 
to be obtained to inform the design of a new framework. However, there 
are actions that the FDA can take now to improve regulatory oversight 
of Class II medical devices. In its report, the committee makes eight 
recommendations geared toward using resources wisely to ensure both 
short-term and long-term benefits. Among the recommended actions are 
that the FDA should strengthen its postmarketing surveillance program 
for devices, identify limitations in the use of its postmarket 
regulatory authorities and address them, and develop and implement a 
program of continuous quality improvement.
    The committee believes that there should be an integrated premarket 
and postmarket regulatory framework that provides a reasonable 
assurance of device safety and effectiveness throughout the device 
lifecycle. Implementation of the committee's recommendations will 
improve regulation of Class II devices in the short term and inform the 
design of the integrated regulatory framework in the long term. 
Ultimately, these changes to the way Class II devices are regulated 
will benefit patients, healthcare providers, the industry, and the FDA.
                                 ______
                                 
    Mr. Chairman and members of the committee, I am David Challoner, 
vice president of health affairs, emeritus, at the University of 
Florida. I also served as chair of the Institute of Medicine's 
Committee on the Public Health Effectiveness of the FDA 510(k) 
Clearance Process. The Institute of Medicine, or IOM, is the health arm 
of the National Academy of Sciences, an independent, nonprofit 
organization that provides unbiased and authoritative advice to 
decisionmakers and the public. Thank you for the opportunity to submit 
testimony for the record based on the IOM's report, Medical Devices and 
the Public's Health: The FDA 510(k) Clearance Process at 35 Years.
                               background
    The Federal Food, Drug, and Cosmetic Act (FFDCA) requires a 
``reasonable assurance of safety and effectiveness'' before a device 
can be marketed. The U.S. Food and Drug Administration (FDA) is 
responsible for enforcing this requirement. Devices that are deemed to 
have a moderate risk to patients generally cannot go on the market 
until they are cleared through the 510(k) process, named for Section 
510(k) of the FFDCA.
    The 510(k) process has become a major component of medical-device 
regulation in the United States. Thousands of devices are cleared via 
the 510(k) process each year--about one-third of devices entering the 
market. The remaining devices are exempt from any premarket review (67 
percent) or enter the market by the premarket approval (PMA) pathway (1 
percent) or by other means such as the humanitarian-device exemption (1 
percent).
    In recent years, individuals and organizations have expressed 
concern that the 510(k) process is neither making safe and effective 
devices available to patients nor promoting innovation in the medical-
device industry. Several high-profile mass-media reports and consumer-
protection groups have profiled recognized or potential problems with 
medical devices cleared through the 510(k) process. The medical-
device industry and some patients have asserted that the process has 
become too burdensome and is delaying or stalling the entry of 
important new medical devices to the market.
                    the charge to the iom committee
    The FDA asked the IOM to review the 510(k) process for medical 
devices and to answer two questions:

    1. Does the current 510(k) process optimally protect patients and 
promote innovation in support of public health?
    2. If not, what legislative, regulatory, or administrative changes 
are recommended to optimally achieve the goals of the 510(k) process?
       the iom committee's conclusion on safety and effectiveness
    On the basis of its review and evaluation of legislative, 
regulatory, and administrative components of the 510(k) process and 
other related components of medical-device regulation, the committee 
came to the conclusion that the 510(k) process is not intended to 
evaluate the safety and effectiveness of medical devices with some 
exceptions. Furthermore, the 510(k) process cannot be transformed into 
a premarket evaluation of safety and effectiveness as long as the 
standard for clearance is substantial equivalence to any previously 
cleared device.
                  the iom committee's recommendations
    The committee believes that the FDA should obtain adequate 
information to inform the design of a new medical-device regulatory 
framework for Class II devices so that the current 510(k) process, in 
which the standard for clearance is substantial equivalence to 
previously cleared devices, can be replaced with an integrated 
premarket and postmarket regulatory framework that effectively provides 
a reasonable assurance of safety and effectiveness throughout the 
device life cycle. Once adequate information is available to design an 
appropriate medical-device regulatory framework, Congress should enact 
legislation to do so. The committee believes that a move away from the 
510(k) process should occur as soon as reasonably possible but 
recognizes that it will take time to obtain the information needed to 
design the new framework.
    In its report, the committee outlines several actions that the FDA 
should take in the short term to improve regulatory oversight of 
medical devices. These actions also will serve to generate the 
necessary information to inform the design of the new framework for 
Class II devices.
    The committee believes strongly that it is important that 
regulatory oversight of devices be conducted throughout their 
lifecycle. Premarket review, including the 510(k) process, and 
postmarket oversight--from product labeling regulations to the 
reporting of adverse events associated with use of a device--make up a 
comprehensive medical device regulatory system. All the components of 
the system need to be functioning well in order to provide a reasonable 
assurance of the safety and effectiveness of medical devices.
    No premarket regulatory system for medical devices can guarantee 
that all new medical devices will be completely safe and effective when 
they reach the market. Robust postmarketing surveillance is essential. 
The FDA should give priority to postmarketing surveillance as an 
invaluable investment in short-term and long-term oversight of medical-
device safety and assessment of device effectiveness. The committee 
identified substantial problems in the current postmarketing 
surveillance of devices, and recommends that the FDA develop and 
implement a comprehensive strategy to collect, analyze, and act on 
medical device aftermarket performance information. Congress should 
support the capacity of the FDA's postmarketing surveillance programs 
by providing stable and adequate funding.
    The appropriate use of postmarket regulatory authorities, such as 
seizing or banning a device, is an essential component of a successful 
medical-device regulatory program. The FDA has stated that there are 
limitations to the use of these authorities but has not identified the 
limitations. The committee recommends that the agency review its 
postmarket regulatory authorities to identify these limitations and 
address them. If it is required, Congress should pass legislation to 
remove unnecessary barriers to the FDA 's use of postmarket regulatory 
authorities.
    It is the committee's assessment that the FDA lacks a continuous 
quality-assurance process for regulation of medical devices. As a 
result, the FDA cannot effectively address new issues as they arise. 
The committee recommends that the FDA develop and implement a program 
of continuous quality improvement to increase predictability, 
transparency, and consistency in all regulatory decisions for devices 
and to address emerging issues that affect decisionmaking.
                                summary
    The IOM committee believes that there should be an integrated 
premarket and postmarket regulatory framework that provides a 
reasonable assurance of device safety and effectiveness throughout the 
device lifecycle. In its report, the committee outlines several actions 
that should be taken by the FDA that will ensure both short-term and 
long-term benefits. Among the actions recommended by the committee are 
that the agency strengthen its postmarketing surveillance program for 
devices, identify limitations in the use of its postmarket regulatory 
authorities and mitigate them, and develop and implement a program of 
continuous quality improvement.
    Thank you, again. I would be happy to answer any questions the 
committee might have.

    The Chairman. Thank you very much, Dr. Challoner.
    Dr. Curfman.

 STATEMENT OF GREGORY D. CURFMAN, M.D., EXECUTIVE EDITOR, NEW 
            ENGLAND JOURNAL OF MEDICINE, BOSTON, MA

    Dr. Curfman. Chairman Harkin, and other distinguished 
members of the committee. My name is Gregory Curfman. I'm a 
cardiologist and the executive editor of the New England 
Journal of Medicine.
    For 200 years, the New England Journal of Medicine has 
published research on novel medical therapies. We're strongly 
committed to innovation in medical treatments, but experience 
has taught us that innovation does not come easily.
    Now, Senator Blumenthal asked for a case study. And I'm 
going to give you a case study. Exactly 2 months ago, on 
September 15, we published an important clinical trial on a 
novel medical device called Wingspan--a highly innovative blood 
vessel stent. Wingspan was designed to reopen narrowed blood 
vessels in the brain, and thus prevent strokes.
    According to the American Heart Association, there are 
795,000 new strokes each year in the United States, And a novel 
therapy effective in stroke prevention would be a major 
advance.
    Wingspan looked very promising. In fact, video images of 
the Wingspan in operation are nothing short of dramatic. Within 
minutes of insertion, the Wingspan stent system can reopen a 
blocked artery in the brain.
    In 2004, a preliminary study of 45 patients showed that 
Wingspan successfully reopened blocked arteries in a high 
percentage. But, the study was very small, it included no 
randomized controls, and so it was impossible to conclude that 
Wingspan actually prevented strokes. Nevertheless, in 2005, on 
the basis of this small study, Wingspan was approved for 
unrestricted clinical use in Europe. It was also approved by 
the FDA, under a humanitarian device exemption, which 
authorizes use in up to 4,000 patients a year, but does not 
require that the device be shown to be clinically effective.
    It was not until November 2008, over 3 years after Wingspan 
was approved for use, that a pivotal, randomized trial of its 
clinical effectiveness, was begun. The study was funded, not by 
the manufacturer of Wingspan, but instead by the taxpayers 
through the National Institutes of Health.
    In the trial, patients at high-risk of stroke were 
randomized to receive Wingspan's stenting or no stenting. It 
was expected that Wingspan would reduce the risk of stroke or 
death. But it did not. In fact, there was a 2\1/2\-fold greater 
risk of stroke or death in the Wingspan group than in the 
unstented group--2\1/2\-fold greater risk.
    Contrary to expectations, this innovative medical device 
actually caused the very clinical problem that it was designed 
to prevent. It was a disturbing result.
    What are the lessons of Wingspan, which, by the way, is 
still on the market with FDA approval. First, implantable 
medical devices such as Wingspan are complex, and regardless 
how innovative they may first appear, their ability to improve 
human health cannot be known until they have been rigorously 
tested in controlled clinical trials.
    Second, benefit for a surrogate endpoint may not 
necessarily translate into benefit for human health. In the 
case of Wingspan, the surrogate endpoint was its success in 
reopening the narrowed blood vessels in the brain. But this did 
not prevent strokes, and in some patients, actually caused 
them. The use of surrogate endpoints for FDA device approval is 
advocated in Senate bill S. 1700.
    Third, the European approach to medical device approval is 
not an acceptable alternative for the United States. In Europe, 
Wingspan received unrestricted approval, even though clinical 
effectiveness had not been established.
    Wingspan is but the latest of examples of a failed medical 
device. Others include, as Senator Harkin already mentioned, 
metal-on-metal artificial hip implants, and the Sprint Fidelis 
implantable defibrillator lead, both of which were also high-
risk devices that received FDA approval without clinical data, 
and harmed many patients.
    Mr. Chairman, legislation recently introduced in both 
chambers that would weaken the FDA approval process for complex 
implantable medical devices, should be viewed skeptically. And 
may not be in the best interest of the health of the American 
people.
    Thank you, Mr. Chairman.
    [The prepared statement of Dr. Curfman follows:]
             Prepared Statement of Gregory D. Curfman, M.D.
                                summary
    Many Americans benefit from the implantation of medical devices; 
tragically, many also suffer or even die from complications related to 
medical devices that were never studied in clinical trials before being 
implanted in a large population of patients. The current device 
approval process, an outdated system created 35 years ago in an era of 
much simpler and few devices, has become less capable of assuring 
safety and effectiveness.
    Two recent, but not rare, examples provide a cautionary tale about 
the challenges of ensuring that complex medical devices are both 
effective and safe. In 2005, a new metal-on-metal artificial hip 
implant, the DePuy (Johnson & Johnson) ASR XL Acetabular System, was 
cleared by the FDA through the 510(k) process by showing that the new 
device was ``substantially equivalent'' to an already-marketed hip 
resurfacing system. Because this was approved through the 510(k) 
process, clearance was based not on clinical trials or other clinical 
data but on bench testing in a laboratory. Once approved, it soon 
became clear that the metal-on-metal hip implant failed at the 
astonishing rate, requiring thousands of additional surgeries to 
replace the defective, painful implants.
    The second example, the Wingspan endovascular stenting system, was 
approved through another less stringent humanitarian device exemption, 
which primarily relied upon data from a small, non-controlled phase I 
trial. A Phase III clinical trial showed a lack of both safety and 
efficacy, 6 years later, just 2 months ago, . The disturbing experience 
with the Wingspan stent system, which harmed many patients, serves as a 
stark reminder that innovative medical devices, regardless of how 
promising they may first appear on the basis of preliminary studies, do 
not always prove to be successful when subjected to rigorous controlled 
clinical trials.
    Additionally, I believe that the July 2011 IOM report, which 
concluded that it was impossible for 510(k) clearance to assure safety 
and effectiveness, is insightful, judicious, sensible, and long 
overdue. I support the IOM committee's recommendation that the 510(k) 
process be replaced with an evaluation of safety and effectiveness.
    As the best long-term improvements are contemplated, there are 
important steps that the FDA can take now. First, the use of 510(k) 
clearance for class III devices should stop, as Congress made clear 20 
years ago. Second, the tenuous practice of allowing use of multiple 
predicates in 510(k) clearance should be eliminated. Third, as was 
recommended by the IOM committee, a formal system of postmarketing 
surveillance for medical devices should be put in place. Fourth, I 
strongly endorse the FDA's Sentinel Initiative and the associated Mini-
Sentinel pilot program. Fifth, I believe that the European medical 
device regulatory system is not a suitable model for the United States 
and would not be in the best interest of the American people.
    I strongly believe that, in the interest of advancing human health, 
patients must have easy access to innovative medical devices and that 
the approval process needs to be sensible and efficient. But no one's 
interest is served by putting defective medical devices onto the market 
where they cause harm to patients, waste health care dollars, and may 
kill jobs when they are withdrawn.
                                 ______
                                 
    Many Americans benefit from the implantation of medical devices, 
such as artificial joints and lifesaving defibrillators. Tragically, 
many also suffer or even die from complications related to the same 
types of medical devices, some of which have never been studied in 
clinical trials before being implanted in a large population of 
patients. As devices have evolved and become more complex, our device-
approval system has become less capable of assuring safety and 
effectiveness. The system we use today was created 35 years ago in an 
era of much simpler and fewer devices, and it is now inadequate.
    A recent, but not rare, example provides a cautionary tale about 
the challenges of ensuring that complex medical devices are both 
effective and safe. Osteoarthritis of the hip joint is a common and 
debilitating disorder. Each year, more than a quarter of a million 
patients with advanced painful arthritis receive a total hip 
replacement in the hope that it will restore mobility and improve their 
quality of life.\1\ Conventional artificial hip implants consist of a 
metal ball inserted into a plastic cup. In 2005, a new metal-on-metal 
design was introduced in which both components were made from a metal 
alloy. The design was touted as a major innovation that would improve 
durability and reduce the risk of hip dislocation--advantages that were 
especially appealing to younger patients. However, these design 
innovations were never tested.
    One metal-on-metal design is the DePuy (Johnson & Johnson) ASR XL 
Acetabular System, which was introduced into the U.S. market in 2005. 
The ASR was cleared by a Food and Drug Administration (FDA) process 
known as 510(k), which refers to the section of the 1976 Medical Device 
Amendments to the Federal Food, Drug, and Cosmetic Act that created it. 
Under that section, the criterion for clearance of a new medical device 
is that it be ``substantially equivalent'' to an already-marketed 
device (a ``predicate''); clinical data are not required nor are data 
on safety and effectiveness.
    The ASR was constructed by borrowing a metal alloy cup from a 
different hip device known as the ASR Hip Resurfacing System and 
retrofitting it onto a standard hip implant. The manufacturer 
successfully made the case that the re-engineered implant was 
``substantially equivalent'' to a predicate device. Its marketing 
clearance was therefore based not on clinical trials or other clinical 
data but on bench testing in a laboratory, which was inadequate to 
simulate the stresses that would be placed on it in patients' bodies.
    It soon became clear that the device failed at the astonishing rate 
of at least one in eight. According to a recent report presented at the 
British Hip Society Annual Conference, 21 percent of these hips have 
had to be replaced (revised) by 4 years after implantation, and the 
revision rate rises to 49 percent at 6 years, as compared with 12 to 15 
percent at 5 years for other devices.\2\ Failure appears to be due to 
erosion of the metal in the articular surfaces and migration of 
metallic particles into the surrounding tissues and the bloodstream. 
Thus, the innovation led to tragedy for many patients.\3\ Before it was 
recalled in 2010, the ASR had been implanted in nearly 100,000 
patients, and the result was a public health nightmare.
    The ASR is a class III device--the FDA's highest risk 
classification. As a high-risk device, it should not be cleared 
(without clinical data) via the 510(k) process, especially as its 
design is novel and thus there is no predicate for a 510(k) clearance. 
Congress envisioned that class III devices would be approved through 
the more stringent premarket approval (PMA) process, which does require 
clinical testing, and the Safe Medical Devices Act of 1990 requires 
that the FDA either use the PMA process for class III devices or 
reclassify them in a lower-risk category. Despite the clear intent of 
Congress, a recent GAO report noted that most high-risk devices 
continue to slip by this requirement. In fact, a recently published 
study found that among high-risk device recalls from 2005 to 2009, 
nearly three-quarters had been cleared through the 510(k) process.\4\
    The Wingspan endovascular stenting system provides yet another 
cautionary tale about the potential risks to human health of innovative 
medical devices. The Wingspan stent was designed to be placed into 
small blood vessels in the brain in patients at high risk of a stroke, 
in order to re-open narrowed vessels to prevent a subsequent stroke 
from occurring. The Wingspan system was approved for use in both Europe 
and the United States in 2005. While in Europe the device received 
standard approval by a notified body, in the United States the FDA 
approved the device with a humanitarian device exemption (HDE), which 
requires a less stringent approval process than standard pre-market 
approval (PMA) and limits use to no more than 4,000 patients per year. 
One phase I trial in 45 patients but no controls, which demonstrated 
angiographic benefit, served as the basis for HDE approval. On the 
basis of this phase I trial, the company optimistically referred to the 
device as a ``groundbreaking system.''
    Just 2 months ago, and 6 years after the Wingspan was approved by 
the FDA, a phase III clinical trial (SAMMPRIS) comparing the device 
with intensive stroke-prevention medical therapy was published in the 
New England Journal of Medicine.\5\ The study was investigator-
initiated and funded by the National Institute of Neurological 
Disorders and Stroke (the commercial sponsor, Stryker Neurovascular 
[formerly Boston Scientific Neurovascular], donated the devices), and 
thus was paid for principally by taxpayer dollars. The hypothesis 
tested in the study was that the stenting system would improve patient 
outcomes, as measured by the primary endpoint of stroke or death within 
30 days of enrollment. After just 451 patients had been enrolled, the 
study was terminated prematurely because of a serious adverse safety 
signal in the stent-treated group. The incidence of the primary 
endpoint (stroke or death) in the stent-treated group was 2\1/2\ times 
greater than in the medically treated group (14.7 percent versus 5.8 
percent), a worrisome result that was unanticipated by the 
investigators. The comparable figures at 1 year were 20 percent and 
12.2 percent. Despite these worrisome outcomes, the device remains 
available in the United States.
    The disturbing experience with the Wingspan stent system, which 
harmed many patients, serves as a stark reminder that innovative 
medical devices, regardless of how promising they may first appear on 
the basis of preliminary studies, do not always prove to be successful 
when subjected to rigorous controlled clinical trials. Implantable 
medical devices are complex pieces of engineering, and bypassing 
clinical testing to rigorously evaluate their function inside the human 
body can result in substantial harm to patients.
    On July 20, 2011, the U.S. House Energy and Commerce Subcommittee 
on Oversight and Investigations held a hearing entitled ``Medical 
Device Regulation: Impact on American Patients, Innovation, and Jobs.'' 
The subcommittee's chairman, Congressman Cliff Stearns (R-FL), argued 
that FDA regulation of medical devices is too burdensome, stifles 
innovation, and drives device manufacturers overseas. Since then a 
number of bills have been introduced in Congress that would diminish 
FDA's ability to assure safety and effectiveness of medical devices. 
But the disastrous outcomes of the use of DePuy ASRs and the Wingspan 
endovascular stenting system show that rushing untested and potentially 
dangerous medical devices into the marketplace carries serious risks; 
our regulators should not be in the business of creating jobs in the 
manufacture of dangerous devices.
    On July 29, 2011, the Institute of Medicine (IOM) released an FDA-
commissioned report on the 510(k) clearance process.\6\ \7\ The report 
concluded that it was impossible for 510(k) clearance to assure safety 
and effectiveness, because it assesses neither, instead establishing 
only ``substantial equivalence'' to an existing device. The report 
therefore recommended that 510(k) clearance be eliminated. In addition, 
it recommended monitoring medical devices throughout their life cycle, 
especially during the postmarketing period. Despite its reasonable (and 
relatively modest) recommendations, the report has been aggressively 
attacked by the device industry and by politicians from States where 
device companies are located. In fact, the attacks began even before 
the report was released, which is highly unusual for an IOM report.
    I believe that the IOM report is insightful, judicious, sensible, 
and long overdue. The 510(k) clearance process was established 35 years 
ago, and although it may have been a reasonable approach then, it 
surely is not today. The 510(k) process was never intended for use for 
clearing Class III medical devices, defined by the Code of Federal 
Regulations as products used for life-supporting or life-sustaining 
indications, for preventing impairment of human health, or presenting a 
potentially unreasonable risk of illness or injury. I support the IOM 
committee's recommendation that the 510(k) process be replaced with an 
evaluation of safety and effectiveness. It is important to maintain and 
encourage innovation in medical devices. But true innovation requires 
that safety and effectiveness be proven by scientific study in clinical 
trials.
    Under intense pressure from the device industry, the FDA leadership 
has already indicated that it does not intend to implement this key 
recommendation of the report, although it may be open to other changes. 
As the best long-term improvements are contemplated, there are 
important steps that the agency can take now.
    First, the use of 510(k) clearance for class III devices should 
stop, as Congress made clear 20 years ago. A substantial equivalence 
standard for clearance of such complex devices is untenable. This 
recommendation was made previously in a report from the Government 
Accountability Office (GAO),\8\ but it has not been fully implemented 
by the FDA.
    Second, the use of multiple predicates in 510(k) clearance should 
be eliminated. Now a device may be cleared if it is found to be 
substantially equivalent to an existing device that was cleared, in 
turn, by being found substantially equivalent to another device, and so 
on. A device can receive 510(k) clearance by being substantially 
equivalent to a device that is no longer on the market. This tenuous 
process should be discontinued.
    Third, if a substantial equivalence standard is to be retained for 
certain devices deemed not of high risk, there must be a clear 
definition of substantial equivalence including the authority of FDA to 
require the submission of clinical data to assess whether the new 
device meets the substantial equivalence definition.
    Fourth, as was recommended by the IOM committee, a formal system of 
postmarketing surveillance for medical devices should be put in place. 
Strong, mandatory, and transparent postmarketing data, in registries, 
allow rapid identification of serious problems that may emerge after 
approval. Careful tracking of every patient with a high-risk device is 
a crucial step for ensuring patient safety and avoiding nightmare 
scenarios. To this end, I hope that the FDA will soon finalize its rule 
about a system of Unique Device Identification (UDI), and then that the 
Centers for Medicare & Medicaid Services will require the UDI to be 
submitted with claims. That would allow safety surveillance for medical 
devices to be much more tractable.
    Fifth, I strongly endorse the FDA's Sentinel Initiative and the 
associated Mini-Sentinel pilot program.\9\ Through the Mini-Sentinel 
pilot program, capabilities are being developed for actively monitoring 
the safety of approved medical products using the electronic health 
information in claims systems, inpatient and outpatient medical 
records, and patient registries. Such a system will be an important 
step forward.
    Sixth, I believe that the European medical device regulatory 
system, in which 82 privately run notified bodies rather than a 
government agency make decisions on market authorization for medical 
devices, is not a suitable model for the United States and would not be 
in the best interest of the American people. Notified bodies do not 
adhere to uniform standards, and device manufacturers can select the 
notified body that will put their device through the least stringent 
assessment of safety and performance. Most surprising, manufacturers do 
not have to demonstrate a beneficial effect on clinical outcomes.
    I strongly believe that, in the interest of advancing human health, 
patients must have easy access to innovative medical devices and that 
the approval process needs to be sensible and efficient. But no one's 
interest is served by putting defective or untested medical devices 
onto the market where they cause harm to patients, waste health care 
dollars, and may kill jobs when they are withdrawn. It is essential 
that the FDA be adequately funded to carry out its mission to ensure 
the safety and effectiveness of medical devices. The IOM report charts 
a path that is right for the future, and despite well-financed outside 
pressures, I urge the FDA to initiate an action plan with congressional 
support to adopt these important recommendations.
                               References
    1. National Hospital Discharge Survey: survey results and products. 
Atlanta: Centers for Disease Control and Prevention, 2009. (http://
www.cdc.gov/nchs/nhds/nhds_products.htm.)
    2. Updated guidance on large diameter metal on metal bearing total 
hip replacements. London: British Hip Society and British Orthopaedic 
Association, March 2011. (http://www.britishhipsociety.com/pdfs/
BHS_MOM_THR.pdf.)
    3. Testimony of Katherine Korgaokar before the Senate Committee on 
Aging, Washington, DC, April 13, 2011. (http://aging.senate.gov/events/
hr233kk.pdf.)
    4. Zuckerman DM, Nissen SE. Medical device recalls and the FDA 
approval process. Arch Intern Med 2011; 171(11): 1006-11.
    5. Chimowitz MI, Lynn MJ, Derdeyn MD, et al. Stenting versus 
aggressive medical therapy for intracranial arterial stenosis. N Engl J 
Med 2011;365:993-1003.
    6. Institute of Medicine. Medical devices and the public's health: 
the FDA 510(k) clearance process at 35 years. Washington, DC: National 
Academies Press, 2011.
    7. Challoner DR, Vodra WW. Medical devices and health--creating a 
new regulatory framework for moderate-risk devices. N Engl J Med 
2011;365:977-79.
    8. U.S. Government Accountability Office. Medical devices: FDA 
should take steps to ensure that high risk device types are approved 
through the most stringent premarket review process. GAO-09-190. 2009.
    9. Behrman RE, Benner JS, Brown JS, McClellan M, Woodcock J, Platt 
R. Developing the sentinel system--a national resource for evidence 
development. N Engl J Med 2011;364:498-99.

    The Chairman. Thank you very much, Dr. Curfman. And thank 
you for that exposition of that one case, and I have a whole 
list of others to go with it.
    Professor Hall, you assert in your testimony that 510(k) 
system generally works pretty well. But how do you reconcile a 
system based on substantial equivalence with the phenomena of, 
what they call, predicate creep? You know what that means--
where device after device is compared with a slightly newer or 
a different version of an original device, such that the newest 
models bear little resemblance to the original? You have the 
original device, you have another iteration of it that's 
substantially equivalent, then there's another device that is 
substantially equivalent to that, and there's another device, 
and on and on to the nth degree. Doesn't this system really 
allow firms to compare apples to oranges, once you get out two 
or three or four or five iterations?
    Mr. Hall. Properly implemented, I do not think the system 
does do that. Let me give you a couple of reasons why.
    In each of these iterative steps, if there is either a new 
indication or a new technology being employed, and again, new 
technology is very, very broadly defined, the sponsor of that 
510(k) submission has to provide data of whatever is the 
appropriate type--clinical data, bench testing, whatever to 
establish safety and effectiveness.
    The agency reviews that and makes a decision. So, what you 
see is a constantly increasing bar. That's how the system is 
designed. So, then my latest generation with another tweak or 
whatever, is not compared simply to the original one from, 
let's say, 20 years ago, but rather, then, we have this 
increasing knowledge.
    Second, the agency has a number of tools to take into 
account new information. We can revise special controls, put in 
place performance standards, etc., all to address newly 
discovered information or experience in the clinical setting.
    The Chairman. Dr. Challoner, there was a lengthy discussion 
in the IOM report about the need to enhance postmarket review 
of devices. What sort of precise fixes, if any, would you 
suggest? What are the gaps in the postmarket authorities that 
you might respond to here?
    Dr. Challoner. This is a major and important tool as you 
look forward to where we're going to be in the next decade or 
so in this industry.
    At the moment, usually, except for a few cases in pediatric 
realm or where you have an interested professional society, 
there are some device-specific areas in which prospective data 
on complications is gathered.
    But, generally speaking, it's an ad hoc system with 
multiple responsibilities for reporting up the chain, if you 
will, to finally come to either public or FDA attention, and 
there's no consistency or regularization of it.
    Now, the opportunity is if you're going to speed up the 
device process for public health safety and efficacy, to have 
the opportunity to be not intrusive on the front end, except 
for manufacturing standards and design issues, and to 
streamline in those processes, as long as you could rely on a 
very consistent population-wide reporting system for 
complications of low incidence and high substance, you would 
begin to have safety and efficacy over the lifetime of a drug. 
New information systems----
    The Chairman. Or device.
    Dr. Challoner [continuing]. Or device. I'm sorry.
    New information systems, new healthcare organizations, 
organizations like Kaiser, and in particularly the VA, give us 
an opportunity to get an early warning system for devices 
through their electronic record systems, that will improve the 
process over time. And I think that needs to be explored by all 
the interested parties as we go forward.
    The Chairman. My 5 minutes are up. I will turn now to 
Senator Franken.
    Senator Franken. Thank you, Mr. Chairman.
    Professor Hall, thank you for coming from Minnesota. You 
have decades of experience working with the FDA, and as CEO of 
a medical device company, and also as a professor of food and 
drug law at the University of Minnesota Law School.
    As you know, I introduced a bill earlier today that will 
get devices to the market faster and more safely, and I know 
you know about the bill because you endorsed it, and thank you 
again for your support. Would you explain why it is important 
to expand the FDA's ability to consult with outside experts 
while maintaining the requirement that the FDA disclose any 
conflicts of interest that advisory panel members may have?
    Mr. Hall. As we see burgeoning technology and whole new 
areas of science, the agency cannot and should not be expected 
to be an expert in anything and everything. And the agency, in 
my opinion, needs access to experts to provide the scientific, 
engineering, material science, whatever expertise, to advise 
the agency so they, then, can make the appropriate risk-benefit 
decision in a safety efficacy scenario.
    I happen to have a personal interest in nanotechnology with 
my academic hat on. It's incredibly complex, and if we don't 
give the agency access to expertise, they're going to be making 
decisions without the benefit of the best science. And we need 
to make sure they have that, in my opinion.
    Senator Franken. We heard from Dr. Shuren that they are 
losing senior people, and there is attrition, and it would be 
nice to work out a system where the higher bar of conflict of 
interest--that exists in, just in this, in the FDA--in this 
field is looked at again.
    Can I, Professor Hall, can I get your take on the IOM's 
report on the 510(k) process?
    Mr. Hall. Let me make a couple of comments--there are 
aspects of the report with which I do agree. For example, 
postmarket surveillance, the importance of a quality system 
within FDA, the need to finalize the classification of post-
amendment classification, and several others.
    I must say, I do disagree with the fundamental conclusion 
that the 510(k) system is not capable of providing a reasonable 
assurance of safety and effectiveness. I think the statute in 
Congress have provided that. I think FDA has implemented that, 
and I think that even as the IOM said, the actual experience 
with the system has been remarkably positive.
    Senator Franken. Thank you very much. Thank you, Mr. 
Chairman.
    The Chairman. Senator Mikulski.
    Senator Mikulski. Thank you. This is a great panel.
    Dr. Challoner, first of all, we so value the Institute of 
Medicine as Senator Harkin said. But this issue of totally 
replacing the 510(k) gives us pause, and I think one of the 
reasons it gives us pause is the looming question of who would 
design the new system? Would we have to approve the new system 
given both the political climate and the clock ticking--when we 
also have to reauthorize MDUFA as we know it?
    What prompted a learned society like IOM to say, ``Throw 
out the whole thing,'' when you know how Congress is working--
or not working. If you're going to criticize FDA for approval, 
criticize us for bill approval.
    So do you, speaking for yourself, believe that there are 
intermediate steps that we could take that would address the 
most cogent and compelling of the issues raised in your report?
    Dr. Challoner. Senator Mikulski, thank you, and the answer 
is that the more we looked at it, and we had a very diverse 
committee--I was on the board of directors of a device 
corporation, a large one, Cortis Corporation, for 6 years. We 
had two attorneys who spent most of their professional life in 
the device industry. We had people, an individual, who had 
taken a device through the process.
    We were surprised, ourselves, as a group, that we all came 
unanimously to the conclusion that the logic of this transition 
system that was put in place with the 75 amendments, simply to 
get from nothing to something, had now had 35 years of a life-
span, and we felt it was not going to be capable of dealing 
with the technology and science of devices for the next two 
decades.
    Therefore, our expectation is not that the FDA would take 
our advice, and dump it next week, and put something in place. 
But we would begin a conversation such as we're having here, 
and at other venues, just as it took 5 years to get the 75 
amendments in place. It may take 5 years of conversation, 
probably managed by the FDA, and the Congress, to be able to 
put in place, that makes use of modern information technology 
over the life-span of a device.
    So, we expect a 5-year transition. In the meantime, there 
are things that can be done with postmarket authorities that 
the FDA has, and with improving postmarket surveillance that 
will immediately improve public health and safety.
    Senator Mikulski. When I read the report, I thought the 
message was essentially--these are Barb Mikulski's words--dump 
it and deal with it.
    Dr. Challoner. No.
    Senator Mikulski. And quite frankly, that message gave 
every one of us a great deal of pause. But what you're saying 
is--well, let's take a look at what you're saying--Mr. Hall, 
Mr. Curfman, and Dr. Shuren have talked reforms; we're all 
talking about reforms and what you are saying in your 
recommendations is that the postmarketing suggestions would be 
the most potent reforms right now to include in any 
reauthorization bid.
    Dr. Challoner. Yes. Would have immediate effects.
    Senator Mikulski. I want to thank the IOM for what they 
did. They certainly started the conversation.
    Dr. Challoner. Good.
    Senator Mikulski. And thank you very much. Thank you, Mr. 
Chairman.
    The Chairman. Senator Blumenthal.
    Senator Blumenthal. Thank you, Mr. Chairman.
    I think what the panel was hearing and what I've heard over 
the last months, maybe longer, is a developing consensus that 
the present system simply isn't working, that it's broken, and, 
in fact, fatally defective, not just in implementation, but 
also concept.
    And I think Senator Mikulski raised the key question, which 
is, what do we do to make it better while we try to improve the 
law? And perhaps I can ask this question of all the members of 
the panel. Isn't one of the things we can do is to improve 
postmarket surveillance? Because that kind of greatly increased 
scrutiny and oversight, at least, can stop harm that may be 
developing, and save patients the hip on hip implants, or the 
Wingspan stent problems, and try to deal with those problems at 
an earlier stage, and thereby, save people from a lot of 
suffering, and even death?
    Dr. Curfman, you've raised those two case studies, and I 
suspect that they may be included in Dr. Shuren's response to 
my question on case studies. But, would increase postmarket 
surveillance be advisable?
    Dr. Challoner. Thank you, Senator Blumenthal. I think 
that's critical, and I know that there are initiatives ongoing 
in the FDA that are quite interesting. And I think that, as 
they're implemented, they are going to really strengthen 
postmarketing surveillance. Dr. Shuren can certainly speak to 
that in more detail than I.
    But, there is a program that is coming to fruition called 
the Uniform Device Identification Program, which is a way of 
giving a unique identifying number to each implanted medical 
device, allowing that device to be tracked throughout its 
lifetime, and hooked up with an individual patient.
    These numerical codes can, then, be linked to outcome data, 
claims data, so that we can, then, find out exactly what's 
happening to the patients who have them.
    Now, this program is very interesting. It's being headed by 
a very high-quality individual within the agency, and I think 
it's going to be a very important step forward when it's 
actually implemented, and I understand that that will be fairly 
soon.
    That's associated with the larger sentinel initiative 
that's ongoing within the FDA. That's associated with the 
larger sentinel initiative that's ongoing within the FDA, and 
the mini-sentinel pilot program, which is a smaller research 
program going on to develop new ways of doing postmarketing 
surveillance. And, here again, there are very high-quality 
people working on these programs within the agency.
    So, I expect that we will be seeing advances in 
postmarketing surveillance, and I agree with you, Senator 
Blumenthal, that this is quite critical as we await larger-
scale changes in the 510(k) program.
    Senator Blumenthal. But, postmarket is really no substitute 
for fundamental reform of the entire 510(k) system.
    Dr. Challoner. It's part of a process, but I don't think 
that it's really going to be enough, in the long run.
    Senator Blumenthal. Professor Hall, I wonder if you would 
comment on those two case studies, for lack of better word, and 
whether you think they don't indicate faults in the present 
process.
    Mr. Hall. I'll be glad to.
    First of all, I only know what's public about those 
situations, and so, I'm not in a position or qualified to make 
any conclusions. I have not reviewed the regulatory submissions 
or anything like that.
    So, what I will try to comment on, given on what I do know, 
publicly, is whether the agency has authority to have addressed 
those issues. I believe the agency does. In the case, again, of 
the metal-on-metal, the agency, submission to the agency is to 
include safety and effectiveness data. The agency can decide 
whether it needs clinical data or not to make that assessment, 
so they have that authority.
    Dr. Shuren talked about that briefly in his comments, as to 
whether they should have. And again, I don't know the details 
on that. But they have the authority to get clinical data, if 
that is what is appropriate in that situation. I do agree with 
the other panelists of the importance of postmarket 
surveillance, and the need to improve postmarket systems so 
that they are more effective and more efficient.
    Within any product issue, the agency has a number of 
authorities to impose warnings, recalls, and postmarket studies 
under section 522--I have to mention at least statutory 
section, otherwise, I guess I'm not really a lawyer in this.
    Senator Blumenthal. So, your point is that, even under 
existing authority, the FDA has the power to be more vigilant 
and vigorous in protecting the public, and, I think many of us 
would agree.
    Mr. Hall. Correct.
    Senator Blumenthal. Thank you. Thank you, Mr. Chairman.
    Senator Hagan. Thank you, Mr. Chairman. And, I too, echo 
Senator Mikulski's comments about this panel. Thank you for 
being here, and it's an excellent group.
    Dr. Challoner, you state that the Institute of Medicine 
Committee believes that there should be an integrated premarket 
and postmarket regulatory framework that provides a reasonable 
assurance of device safety and effectiveness throughout the 
device lifecycle. Can you elaborate on this, and what you think 
we need to see?
    Dr. Challoner. We just don't have enough data at the 
moment, and, our charge, if you will, in making our 
recommendation to the FDA is that it needs to spend some time 
with its varied constituencies over the course of the next 
several years, finding out exactly what kind of data they need 
about their processes, that will make them more transparent and 
predictable.
    Dr. Shuren has already undertaken, parallel with our 
report, many of these items. But there are some things in which 
we just don't have data.
    There's a difference between postmarket surveillance and 
the identifier issue that Dr. Curfman just raised, and 
postmarket authorities already in place, for instance, that may 
or may not be used adequately to survey and monitor the 
postmarket arena. And it may be because the data just isn't 
coming forth from the clinical environment to the leadership of 
the FDA.
    For instance, there's a seizure authority, and the agency 
has brought about 13 seizure actions from fiscal year 2001 to 
2008. Now, is that adequate? I don't know. The absence of 
evidence is not evidence of absence; banning, used once since 
1976; recall orders, the agency has not formally tracked recall 
orders, but believes the authority has been used at least three 
times in the last 20 years.
    So, we were unable to get enough data to really understand 
how to put all of this in place, which is why we suggested that 
things need to change, and that a process needs to be put in 
place to study it, gather the data, and understand it.
    Senator Hagan. Thank you.
    Professor Hall, we've heard from the other two panelists 
that the 510(k) process or program isn't working well; 
primarily from a safety perspective. However, you've got a 
different view of this process.
    Can you elaborate on the safety findings that you mention 
in your testimony, and do you think the 510(k) program is, 
generally, working well. Or should it be replaced, and what do 
you envision the impact to industry and access to medical 
devices are if the 510(k) program, was, in fact, scrapped?
    Mr. Hall. There are a number of studies--I have done one 
that has looked at the safety profile of medical devices. I 
mention mine, Dr. Maisel, now with FDA, has done a study, FDA 
recently did a study. IOM, itself, said that they find no 
evidence of a systemic problem with medical devices.
    What my study, in particular, did, is that we looked at all 
class I recalls for a 5-year timeframe, looked at the reason 
for the recall, etc. What that data indicates is that quality 
systems are, by far, the most potent tool to use to increase 
product safety.
    This links in directly to your earlier question about 
integrated postmarket and premarket. Outside of the formal 
510(k) system, you have quality systems. So, for example, a 
company is to have a corrective and preventive action program 
by which they track information, product trends of problems, 
then decide using that data--does a correction need to be made? 
That data is also to be fed into the front end of the design 
process for the next iteration of devices, so we get into this 
continuous improvement loop, using data that exist.
    Can that be made stronger? Do we need, I think we're all in 
agreement we can do a better job on postmarket. But, the recent 
study by FDA also indicated that the primary cause of recalls 
are quality system challenges, not issues with, for example, 
lack of clinical trials or other issues.
    Senator Hagan. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Hagan.
    I want to get on this issue of clinical data. I heard you 
say, Mr. Hall, that FDA can--of course, we request clinical 
data, to see if something is equivalent to the predicate.
    If I reference the IOM report again here, in the United 
States, use of clinical data in the regulatory review process 
is defined by the enabling legislation, regulations and FDA's 
implementation of the legislation and regulations. The clinical 
data can be requested by the FDA only if necessary to determine 
that the new devices are as safe and as effective as a 
predicate device.
    Moreover, the agency may not ask for scientific evidence, 
greater than the ``least burdensome,'' to answer the question. 
In practice, clinical data play a very small role in the 510(k) 
process. The GAO found that from fiscal year 2005 to 2007, 
about 15 percent of class II and class III 510(k) submissions 
had new technologic characteristics.
    The FDA found that only 8 percent of 510(k) submissions 
include certain elements, I don't get into all of that. Less 
than 1 percent of non-in-vitro diagnostic 510(k) submissions 
reference a clinical trial. So, again, there's not very much 
clinical data for the vast majority of the devices that are 
asked for clearance under the 510(k) process, is that not true?
    Mr. Hall. I think you have to look at the reasons the 
510(k) was submitted. There are many 510(k)'s that are 
submitted for changes in the product, for which clinical data 
is simply irrelevant.
    For example, one has to submit a 510(k) if one is adding a 
warning to a product. Now, you don't need clinical data for 
that.
    Senator Franken asked about the new modifications guidance. 
If you change suppliers under that, that requires a 510(k). 
Again, clinical data would seem to be not important to deciding 
whether it's appropriate to change from supplier A to supplier 
B.
    So, I think you need to look at the subset of submissions, 
and then ask the question, does the agency have the authority 
or is that information being submitted.
    Senator Harkin. It would seem to me, Professor Hall--I ask 
Dr. Curfman for his thoughts on this--that, if you're talking 
about an implantable device, and a company is going through the 
510(k) process, based on a predicate, obviously, that is where 
postmarket surveillance would be most important.
    What happened from the original through the first 
iteration, the second iteration, the third iteration, the 
fourth iteration? What happened to people out there? We don't 
have that. The FDA is not really doing that, now.
    Why aren't they doing it? Well, let's see. Let's go back 
here to the report. The FDA's device postmarketing surveillance 
programs have been adversely affected by the instability of the 
agency's congressional financing. Interesting.
    Moreover, user fees can be used only for premarket 
activities. The inadequate postmarketing surveillance systems, 
both those in the FDA and those which are privately funded, and 
the resulting lack of useful, consistent, and reliable data 
make it impossible to draw confident conclusions about the 
performance of medical devices now in the market.
    So, now I can get to the nub of it. If the clinical data is 
not there because we don't have enough postmarket surveillance, 
we don't have enough postmarket surveillance because Congress 
doesn't fund it well enough, and user fees cannot be used for 
postmarket surveillance, we have a conundrum. We have a 
conundrum.
    Mr. Hall. Let me try to be clear with my comments. There 
are many circumstances in which clinical data is important. I 
think you're absolutely--implantable, right.
    The Chairman [continuing]. Implantable, right. I preface it 
by saying implantable devices.
    Mr. Hall. For many of those, it's important. I agree with 
you completely, about the importance of postmarket 
surveillance. I think you and I are in absolute agreement on 
the importance of that, and the need to make sure that the 
system is effective and efficient.
    The Chairman. Let me ask you this question.
    Mr. Hall. Yes.
    The Chairman. You have a device company, or you're CEO of 
one, or something--let me ask you this--should user fees also 
be used for postmarket surveillance?
    Mr. Hall. I believe in an adequately funded agency.
    The Chairman. Hey, I'm asking you if----
    Mr. Hall. I understand. And the reason I hesitate is--I'm 
on record. I'm Don Quixote occasionally, OK? I'm on record as 
saying that user fees are bad public policy. That doesn't mean 
the agency shouldn't be funded. Alright? I just think the 
source of funding--there are better sources of funding than 
user fees. I recognize, completely, the current financial 
situation, which is why I may be Don Quixote in my views on 
that. But, I do think we need adequate funding.
    One of the challenges of using user fees for postmarket 
surveillance is that we are actually taxing innovation. Because 
the people paying user fees are the ones with the new ideas, 
the postmarket surveillance is for old products. They are 
already out there.
    And, so, that's one of the reasons, I think, we need to 
come up with a better funding mechanism.
    The Chairman. Yes.
    Mr. Hall. But, that's me, and I didn't say----
    The Chairman. But, the innovation, the new products is 
based upon all those predicates that came before it.
    Mr. Hall. Most of your user fees, as Dr. Shuren pointed 
out, come from PMAs, not from 510(k)'s.
    The Chairman. But, a lot still comes through the 510(k) 
process.
    Mr. Hall. Right. I'm in agreement. We need postmarket 
surveillance, and it needs to be funded. I absolutely agree 
with that.
    The Chairman. Any observations from you, Dr. Challoner or 
Dr. Curfman, about this? Dr. Curfman, I will single you out 
first because you had, sort of, spoken about postmarket 
surveillance.
    Dr. Curfman. Mr. Chairman, I think you've focused, very 
appropriately, on the implantable high-risk class III devices--
that's really where a lot of our concern is, and where we most 
need the clinical information that you've referred to.
    The use of the 510(k) clearance for class III devices 
really needs to stop, and Congress called for that 20 years 
ago. It still hasn't stopped. That needs to stop.
    You've also referred to the use of multiple predicates--
this daisy chain of predicates to approve high-risk devices. 
It's clearly inappropriate--I disagree with Mr. Hall about 
this. It just doesn't make sense. And that, also, needs to be 
eliminated.
    If 510(k) is going to be retained for some devices of lower 
risk, then we need to have a very clear definition of what 
we're talking about for substantial equivalence, and FDA needs 
to be able to call for clinical data to substantiate that 
definition of substantial equivalence for a particular device. 
So, I would agree with you, Mr. Chairman, we need more clinical 
data in all of these realms.
    The Chairman. Dr. Challoner, any observations on this? I 
keep quoting from your report.
    Dr. Challoner. Right. Thanks, you've already spoken for me, 
Mr. Chairman.
    The Chairman. The more I get into this--as a Chairman, I've 
peripherally been involved in the past, the more I'm just 
wondering if--perhaps a simple reauthorization is really not 
what's needed. Perhaps, we have reached a point in time after 
35, 36 years, that we need to take a more intense look at this 
whole realm of the approval process, postmarket surveillance, 
especially for certain higher risk devices. Obviously, some 
were so low-risk, no big deal. And, perhaps, we need to step 
back a little bit, and take a look at this.
    I agree with the Professor, I fought all my adult life 
against having user fees when I put on my agriculture hat, 
against user fees for things like meat inspection. I mean, 
you're going to have the companies that slaughter the meat do 
the inspection? It's for the public good that we have the meat 
inspectors.
    I've often said all along that our FDA had to be fully 
publicly funded. But, in this present climate, that is not 
going to happen. And, so, the user fee system has been in place 
for a long time, and it looks like something we're just going 
to have to live with.
    But, nonetheless, we still want to make this system one 
that, first and foremost focuses on safety and that we have a 
definable pathway that's transparent, that industry can rely 
upon, and know, I mean, this is where I agree with the 
industry. A lot of times, it's sort of opaque, on how the 
process is going to go. And I think the IOM report pointed that 
out also. So, we need some more clearly defined pathways.
    I also say, just sort of off the top of my head after 
reading all this, and going through the IOM report, I wonder if 
there shouldn't be a limit on how many predicates there can be? 
Maybe there should be the initial device. Maybe it can do one, 
and maybe, to the second degree after that, they have to go 
back and start the process over again, so you don't get devices 
to the nth degree out there, that bear very little resemblance 
to what was initially approved.
    But, thinking about that, you limit the 510(k) process to a 
certain limited number of predicates. After that, you'd have to 
go back to the entire process again. And, then, looking at the 
class III, the devices that are, well, I just call them 
implantable devices, that really cause a lot of risk, and need 
to have a lot of postmarket surveillance as we go along. How we 
fund that, I just don't know. But, I'm thinking that, maybe, 
user fees also need to be used for postmarket surveillance.
    I know what you're saying, Professor Hall, that user fees 
are to be approved. But a lot of times, the approval is based 
upon what happened before, so I don't know where the two 
separate, sometimes.
    Those are just my thoughts. It's not an easy subject, and 
it's not one that lends itself to any real easy answers, I 
know. But, I think through this process, we might come up with 
some better suggestions.
    I'm concerned that we might be reauthorizing this, and not 
doing a more adequate job of refining, and redefining the 
process along some of the lines of the IOM, maybe not all of 
it, but along some of the lines. And at least putting a 
spotlight and some focus on, and some support for postmarket 
surveillance.
    Thank you all very much. This has been very healthy, a very 
good interchange, and I learned a lot here, today.
    I request that the record be kept open for 10 days so that 
statements and questions can be submitted for the record. Did 
anyone else have anything else they wanted to add?
    Thank you all very much. I appreciate it, very much, for 
being here. Meeting is adjourned.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

   Response to Question of Senator Bennet by David R. Challoner, M.D.
    Question. Professor Hall, you cited that over 90 percent of all 
Class I recalls are directly related to quality system issues and Dr. 
Curfman and Dr. Challoner you also cite the need for increased quality 
assurance from companies as well. What can Congress do to directly 
address this quality system and quality assurance problem?
    Answer. The IOM Committee on the Public Health Effectiveness of the 
FDA 510(k) Clearance Process focused on how the lack of an effective 
continuous quality assurance program within the FDA's Center for 
Devices and Radiological Health (CDRH) has hindered the agency's 
ability to assess the effectiveness of the 510(k) program. As detailed 
in the committee's report, without adequate management and information 
technology infrastructure, the FDA cannot address new problems as they 
arise or develop a long-term vision of CDRH and its mission. For 
example, the FDA does not currently have the ability to trace the 
history of the 120,000 or so 510(k) decisions made during the last 35 
years and, therefore, the potential exists for problematic devices to 
continue to be used as predicates because there is no systematic way to 
identify them. The committee recommends that the FDA develop and 
implement a program of continuous quality improvement to track 
regulatory decisions on devices, identify potential process 
improvements in the device regulatory framework, and address emerging 
issues that affect decisionmaking. The committee did not recommend 
specific actions by Congress with regard to establishing a program of 
continuous quality assurance for devices within the FDA or the medical 
device industry. It should be noted, however, that the committee did 
determine that the FDA does not currently have adequate resources for 
its multiple responsibilities and implementation of a quality assurance 
program would require such from Congress.

    [Whereupon, at 4:53 p.m., the hearing was adjourned.]

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