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7
Conclusions and Recommendations
A
s noted in Chapter 1, the committee was charged by the Food and
Drug Administration (FDA) to review the 510(k) clearance process
and answer two principal questions: Does the current 510(k) clear-
ance process optimally protect patients and promote innovation in support
of public health? If not, what legislative, regulatory, or administrative
changes are recommended to achieve the goals of the 510(k) clearance pro-
cess optimally? To address its charge, the committee took a multipronged
approach in its evaluation of the 510(k) clearance process, as summarized
in Chapters 2–6. Aspects of the 510(k) process and other relevant factors
that were evaluated include the following:
• he legislative history of the 510(k) process.
T
• he 510(k) regulatory framework that resulted from legislation.
T
• ow the 510(k) process fits into the larger medical-device regula-
H
tory framework. (The 510(k) clearance process is an integrated
component of the larger medical-device regulatory framework. The
committee elected to evaluate the 510(k) program in the context of
this larger framework.)
• ow the 510(k) process is currently implemented by the FDA.
H
• vailable postmarket information on the safety and effectiveness of
A
510(k)-cleared devices.
• ther factors that affect medical-device regulation (for example, the
O
process of innovation and the medical-device ecosystem in the United
States and in other jurisdictions).
189
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190 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
The body of evidence gathered from the committee’s evaluations influ-
enced its deliberations. The conclusions and recommendations presented in
this chapter are the results of the committee’s deliberations.
PROTECTING THE PUBLIC’S HEALTH BY ENSURING THE
SAFETY AND EFFECTIVENESS OF MEDICAL DEVICES
To assess whether the 510(k) clearance process is protecting the public’s
health by providing reasonable assurance that marketed Class II medical de-
vices are safe and effective, the committee explored two avenues. The com-
mittee studied 510(k)-related legislation to determine whether the statute
governing the 510(k) program provides for the FDA’s goals for this program
(described below). The committee also evaluated available information on
the safety and effectiveness of marketed medical devices.
The Regulatory Framework of the 510(k) Program
As outlined in Chapters 2 and 4, the committee found a substantial
disconnect among the committee’s statement of task, the Center for Devices
and Radiological Health (CDRH) statement of the goals of the 510(k) clear-
ance process, and the FDA’s statute governing the 510(k) clearance process.
The committee’s statement of task reads:
The current 510(k) process reflects the statutory framework and the U.S.
Food and Drug Administration’s (FDA) implementation of the framework;
it is intended to meet two important goals: 1) make available to consum-
ers devices that are safe and effective, and 2) promote innovation in the
medical device industry.
Similar language describing the goals of the 510(k) process are included
in the CDRH Preliminary Internal Evaluations, Volume 1—510(k) Work-
ing Group Preliminary Report and Recommendations (FDA, 2010a, 128),
which states that
the aim of the 510(k) program is two-fold: (1) to assure, through a quality
review process, that marketed devices, subject to general and applicable
special controls, provide a reasonable assurance of safety and effectiveness;
and (2) to foster innovation.
However laudable those goals may be, they are not the purposes that
Congress embedded in the 510(k) program (Findings 2-2 and 2-5).
In practice, the assessment of substantial equivalence generally does not
require evidence of safety or effectiveness of a device. Unlike the premarket
approval (PMA) process, by law the 510(k) process, with some exceptions
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CONCLUSIONS AND RECOMMENDATIONS
(discussed below), focuses solely on the determination of a device’s sub-
stantial equivalence to a predicate device. According to the FDA and the
Supreme Court, when the FDA finds a device substantially equivalent to a
predicate device, it has done no more than find that the new device is as
safe and effective as the predicate (OTA, 1984, p. 128).1 It is important to
note that individual devices on the market before the enactment of the 1976
Medical Device Amendments (MDA)—the origin of all predicate devices for
the 510(k) process—have never been systematically assessed to determine
their safety and effectiveness (Finding 2-1). The FDA created advisory
panels to assist in the device classification process. These panels reviewed
information on the risks posed by types of devices, including the potential
risks resulting from a failure of lack of effectiveness, and recommended
into which class the device type should be placed, in order to provide a
reasonable assurance of safety and effectiveness. Neither the panels nor the
FDA itself undertook an assessment of the clinical safety or effectiveness
of individual devices during the original classification process. Because the
preamendment device to which equivalence was established was not itself
reviewed for safety or effectiveness, the committee found that clearance of
a 510(k) submission was not a determination that the cleared device was
safe or effective (Finding 4-1).
Under the Safe Medical Devices Act of 1990, the FDA is permitted to
require evidence of safety and effectiveness, including clinical studies, when
it is necessary for determining whether a difference in technologic charac-
teristics between a new device and its predicate renders the new device less
safe or effective than the predicate or raises different questions of safety
and effectiveness from the predicate. If, despite the change in technologic
characteristics, the new device is as safe and effective as the predicate, it will
be found substantially equivalent.
Nearly all 510(k) submissions for devices that have new technologic
characteristics receive a determination of substantial equivalence. About
15% of Class II and Class III 510(k) submissions for which the FDA reached
a determination of substantially equivalent or not substantially equivalent
in FY 2005–2007 had new technologic characteristics (GAO, 2009a). Some
99.5% received a determination of substantially equivalent.
The 510(k) clearance process has evolved from 1976 to the present
through administrative and legislative changes, narrowing the array of is-
sues that the FDA may consider in a 510(k) review, and limiting the type
of evidence the FDA could require. Throughout the entire period, there has
1Memorandum Re: Internal Control Weaknesses in the Food and Drug Administration’s
Medical Device 510(k) Review Process, from the HHS inspector general to the HHS assistant
secretary for health (July 5, 1990) 1, fn. 1; Brief for the United States as Amicus Curiae
Supporting Respondents/Cross-Petitioners 19-20, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)
(No. 95-754) (some internal citations omitted); Lohr, 518 U.S. at 493-94 (citations omitted).
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192 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
been a high frequency of finding of substantial equivalence (Finding 2-6).
Furthermore, the gap in relative burdens on manufacturers between the
510(k) process and the PMA process created by the 1976 MDA has been
maintained by administrative and legislative changes, which have encour-
aged preferential use of the 510(k) process (Finding 2-7).
Available Recall Data on 510(k)-Cleared Devices
The committee explored FDA recalls of medical devices as a potential
indicator of their safety and effectiveness. Proponents of the 510(k) clear-
ance process have cited the low number of Class I recalls associated with
510(k)-cleared devices as an indication of the safety of devices on the mar-
ket. (The FDA classifies recalls in reverse order of device classes. Class I re-
calls denote the greatest immediate risk to the health, whereas Class I devices
present the lowest inherent risk to health.) In contrast, consumer-protection
advocates have cited several high-profile medical-device safety issues, some
reported in the mass media, as evidence that premarket review via the 510(k)
process is inadequate. They have expressed concern that the FDA’s ability
to recall problematic medical devices cleared through the 510(k) process is
insufficient (Bloomberg News, 2008; Harris, 2010a, 2010b; Hines et al.,
2010; Meier, 2010; Mundy and Favole, 2009; Shuren, 2010; Stein, 2010;
Zuckerman et al., 2011).
Although the committee cites recall data in this report, it recognizes
that using these data as an indicator of device safety and effectiveness has
several shortcomings. The committee also recognizes that mass-media re-
ports of problematic medical devices that were cleared through the 510(k)
clearance process do not necessarily represent generalizable evidence about
the soundness of the entire 510(k) program.
The committee does not believe that there is a public-health crisis re-
lated to unsafe or ineffective medical devices. The committee found that
available postmarketing-surveillance data do not provide sufficient informa-
tion about potential harm or lack of effectiveness to be a useful source of
data about the safety and effectiveness of marketed devices (Finding 5-2).
As noted in Finding 2-1, although the safety and effectiveness of preamend-
ment Class II devices has not been systematically reviewed, their continued
use in clinical practice provides at least a level of confidence in their safety
and effectiveness.
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CONCLUSIONS AND RECOMMENDATIONS
Does the 510(k) Clearance Process Provide a Reasonable
Assurance of Safety and Effectiveness?
The committee found that the 510(k) program lacks the statutory basis
to make it a reliable premarket screen for safety and effectiveness of Class
II medical devices. Therefore, the committee drew the following conclusion:
Conclusion 7-1 The 510(k) clearance process is not intended to
evaluate the safety and effectiveness of medical devices with some
exceptions. The 510(k) process cannot be transformed into a pre-
market evaluation of safety and effectiveness as long as the standard
for clearance is substantial equivalence to any previously cleared
device.
The committee is not suggesting that all, many, or even any medical
devices cleared through the 510(k) clearance process and currently on the
market are unsafe or ineffective. Rather, the committee found that the
available information is insufficient to support highly confident conclusions
about the safety and effectiveness of 510(k)-cleared medical devices in clini-
cal use. As elaborated on below, the committee is concerned by the lack of
information-gathering efforts to identify potential safety and effectiveness
problems with devices and by the ineffectiveness of the regulatory system
to respond to problems if they are identified (Finding 3-2).
FACILITATING INNOVATION IN SUPPORT OF PUBLIC HEALTH
As discussed in Chapter 6, views diverge on what constitutes innova-
tion in medical devices. The committee agreed on a definition of innovation
to assess whether the current 510(k) clearance process optimally protects
patients and promotes innovation in support of public health. The commit-
tee believes that given the broad interpretation of the term it should define
innovation not simply as a change but as a favorable change in the context
of public health. The committee also believes that given the complexity of
the process of innovation and the iterative and combinatorial nature of the
process a broad definition would be more accurate than one that sought to
create a list of specific attributes. The committee defined innovation broadly
as improving the quality of, efficiency of, or access to health care.
To assess how innovation is affected by medical-device regulation, the
committee studied the legislative history and implementation of the 510(k)
process and findings from the medical-device industry about the effect of
the 510(k) process on innovation. The committee found that the 510(k)
clearance process was not designed to reward, recognize, or encourage in-
novation. At most, promotion of innovation was a byproduct of a process
that, by minimizing unnecessary regulatory burdens, facilitated the entry
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194 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
into the market of new devices that do not raise novel questions of safety
or effectiveness (Finding 2-4). In reducing regulatory burdens and providing
additional resources to allow for timely review, the changes in the original
legislation over the past 35 years have neither forced nor rewarded in-
novation. Although it may be argued that such changes may improve the
likelihood of innovation, it remains unclear, and the committee argues that
it is indeterminable given current data, whether the legislative changes have
promoted innovation.
The 510(k) clearance process is generally more economical, faster, and
less burdensome than the PMA process for both industry and the FDA
(Finding 3-3). Substantially fewer postmarket controls apply to 510(k)-
cleared devices than to PMA devices. Since the implementation of the
MDA of 1976, which created both programs, there has been a substantial
difference between the 510(k) process and the PMA process in premarket
requirements. The committee found that over the past 35 years legislative
and administrative changes in the 510(k) program have maintained that
gap in requirements between the 510(k) and PMA programs. The disparity
in program requirements, costs, and postmarket requirements encourages
preferential use of the 510(k) process (Finding 2-7). Although the 510(k)
clearance process offers a less burdensome pathway to market, the increas-
ing complexity of devices is challenging the capabilities of this process
(Findings 6-1, 6-2, 6-3, and 6-4). The committee believes that a regulatory
pathway based on demonstrating substantial equivalence to predicate de-
vices is not a rigorous scientific means of adapting to new and increasingly
complex types of technology.
Several assessments of the 510(k) program conclude that the FDA’s
implementation of the program, not the underlying process itself, has
stifled innovation because of a lack of transparency and predictability,
which has led to an adverse effect on venture-capital investment in future
medical-device development (Finding 6-5). Typical measures used in those
assessments are the ease of premarket review and relative speed to market
compared with the European Union premarket process (Ernst and Young,
2009; Lewin Group, 2010; Makower et al., 2010; MDMA and NVCA,
2009; PwC and BIOCOM, 2010). The committee, however, does not believe
that such factors as ease of premarket review and relative speed to market
are surrogates for innovation.
The FDA has procedures to develop, adopt, and implement guidance
and standards. It is persistently hindered, however, in fully developing these
materials by a lack of or limitations in human, fiscal, and technologic re-
sources and capabilities (Finding 3-4). Confusion regarding key regulatory
phrases (for example, intended use and indications for use) has created
uncertainty about the decision-making process (Finding 4-3). The process
also is restricted in how it evaluates devices in that it currently does not
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CONCLUSIONS AND RECOMMENDATIONS
recognize the distinction between devices cleared as tools and devices cleared
for specific clinical applications (Finding 4-4). Those factors create confu-
sion regarding the types of questions asked by reviewers and the types of
information needed in premarket submissions.
In its Task Force on the Utilization of Science in Regulatory Decision
Making Preliminary Report and Recommendations, CDRH identified sev-
eral institutional, structural, and resource concerns regarding the timely
incorporation of new science in premarket review (FDA, 2010b). The report
found that the
CDRH has not yet articulated a business process to be followed across the
Center for evaluating new scientific information and determining when that
information warrants certain types of action, such as a change in premarket
evidentiary expectations.
The Utilization of Science report also states that CDRH finds it chal-
lenging to communicate changes in regulatory thinking both within the
agency and externally in response to new information and that this challenge
affects all stakeholders. Industry representatives have expressed concern
about the increasingly required use of clinical data in the 510(k) review.
The committee’s evaluation found that the FDA has provided inconsistent
guidance in determining the need for clinical data, the type of data, and the
manner in which data, if available, should be integrated into the decision-
making process (Finding 4-8). The lack of clear guidance affects the timeli-
ness and consistency of 510(k) device submissions provided by industry and
the ability of reviewers to evaluate them.
Does the 510(k) Clearance Process Promote
Innovation in Support of Public Health?
On the basis of the above findings, the committee was unable to de-
termine whether the 510(k) clearance process is facilitating or inhibiting
innovation. Therefore, the committee concludes as follows:
Conclusion 7-2 Information that would allow an understanding
of the extent to which the 510(k) clearance process facilitates or
inhibits innovation does not exist.
The committee believes that although the regulatory process can facili-
tate innovation that improves public health by making safe and effective
Class II medical devices available to consumers in a timely manner, the FDA
should not be the arbitrator of what constitutes innovation, nor should it
seek to channel device development and premarket review toward agency-
determined public-health priorities. In the committee’s opinion, the FDA’s
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196 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
role in facilitating innovation in Class II medical devices through premarket
review should be to create a regulatory framework that sets appropriate
thresholds for bringing products to the market. The thresholds should be
stringent enough to satisfy the agency’s objective of ensuring that marketed
medical devices will be safe and effective throughout their life cycles but
realistic enough to permit timely entry of new devices that may offer im-
provements over already marketed devices. Rather than be charged with
promoting innovation, the committee believes that the FDA should seek to
facilitate it, ensuring that the premarket review of Class II devices does not
needlessly inhibit innovation.
RECOMMENDATIONS
On the basis of the above conclusions, the committee offers the follow-
ing recommendations aimed at improving regulation of Class II medical
devices.
Recommendation 7-1 The Food and Drug Administration 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 effective-
ness 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) clear-
ance 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.
It is essential that the new regulatory framework be based on sound sci-
ence. The committee does not believe that available information is adequate
to inform the design of an appropriate framework. Nor does the committee
believe that the new framework should be developed in isolation from other
components of the FDA’s medical-device regulatory system. In developing
the new framework for Class II devices, the efficiency, cost, and effective-
ness of the PMA process should be evaluated. The FDA should carefully
consider what types of evidence are necessary to demonstrate a reasonable
assurance of safety and effectiveness in the new framework. It is beyond the
committee’s scope of work to detail those types of evidence. The committee
believes that it may be possible for the performance of comparative devices
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CONCLUSIONS AND RECOMMENDATIONS
to be a component of the evidentiary materials supporting a claim of safety
and effectiveness of Class II devices.
The FDA should be clear that its role in facilitating innovation in medi-
cal devices is to develop regulatory thresholds that are rigorous enough to
satisfy the agency’s primary objective of ensuring that marketed medical
devices will be safe and effective throughout their life cycles but realistic
enough to permit timely entry of new devices into the market.
On the basis of its findings, the committee identified several topics to
which the FDA should give particular consideration as it develops a new
framework. A number of existing and emerging technologies (for example,
combination products, software, nanotechnology, and medical robotics)
merit detailed thought as part the development of the new framework.
The FDA should consider integrating some elements of the quality-system
regulations, especially those related to design controls and product-release
criteria, into the premarket review process of the new framework to demon-
strate that devices will perform as represented by their manufacturers. The
FDA should also consider, as part of the new framework, including a more
extensive review of device labeling and a system to track labeling changes.
A comprehensive review of the successes and problems of device regula-
tion over the past 35 years would better inform the FDA and Congress as
to whether and how to change the overall regulatory structure for devices.
Finally, medical-device regulatory systems in other countries and jurisdic-
tions should be evaluated to determine whether components of those sys-
tems could inform the design of the new regulatory framework in the United
States. The committee notes that medical-device regulatory systems in other
countries that have robust medical-device markets do not use substantial
equivalence to predicates as the standard for approval for marketing (Find-
ing 6-8).
The committee urges the FDA to create a regulatory framework that
more closely matches the ideal regulatory framework outlined by the com-
mittee in Chapter 1. The attributes of this regulatory framework are as
follows. They are not presented in any priority order.
• T
he process should be based on sound science.
• T
he process should be clear, predictable, straightforward, and fair.
• T
he process should be self-sustaining and self-improving.
• T
he process should facilitate innovation that improves public health
by making medical devices available in a timely manner and ensuring
their safety and effectiveness throughout their life cycle.
• he process should apply relevant and appropriate regulatory au-
T
thorities and standards throughout the life cycle to ensure safety and
effectiveness.
• he process should be risk-based.
T
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198 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
FDA staff at all levels, the medical-device industry, consumers, health-
care providers, payers, and Congress must play a role in the development
of the proposed regulatory framework.
The committee does not believe that further investment in the 510(k)
process is a wise use of the FDA’s scarce resources and is not recommending
specific changes in the 510(k) clearance process itself. Instead, it believes
that the FDA’s resources would be put to better use in addressing problems
with other components of the medical-device regulatory framework and
with the FDA’s decision-making processes and obtaining information needed
to develop a new framework for Class II medical devices. The committee’s
recommendations for accomplishing those goals are detailed below. The
committee recognizes that scarce resources in the FDA could affect its ability
to implement these recommendations. Therefore, it has directed the recom-
mendations toward activities that are useful in both the short term and the
long term and that conserve scarce resources.
The committee recommends that the FDA promptly implement Recom-
mendations 7-2 to 7-8, found below. The committee believes that following
these recommendations will allow the FDA to
• evelop the information base on which to establish the new regula-
D
tory framework.
• ddress problems with postmarketing surveillance and with use of
A
postmarket regulatory authorities.
• evelop and implement a continuous quality-improvement system
D
in CDRH.
Postmarketing Surveillance
As stated repeatedly in the report, the 510(k) clearance process is not a
stand-alone program but a component of the larger medical-device regula-
tory framework. As part of that framework, the 510(k) program depends
on the effectiveness of other regulatory components. The committee found
weakness in postmarketing surveillance of medical devices (Findings 4-5,
4-6, 5-1 to 5-7, and 6-7).
The committee found evidence that the FDA’s postmarketing surveil-
lance systems, as well as other postmarket activities, often do not provide
sufficient information about potential harm or lack of effectiveness of
marketed devices (Findings 4-5 and 5-2). The FDA’s active postmarketing
surveillance programs, such as MedSun and MD EpiNet, have potential but
will require stable, adequate resources and resolution of various technical
issues to achieve their full promise (Finding 5-5). The FDA is including medi-
cal devices in the Sentinel Initiative; additional investment will be needed to
develop a rich source of clinical data on medical devices. The FDA’s device
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CONCLUSIONS AND RECOMMENDATIONS
postmarketing surveillance programs have been adversely affected by the
instability of the agency’s congressional financing. Moreover, user fees can
be used only for premarket activities (Finding 2-8). Non-FDA postmarket-
ing surveillance activities, such as privately funded device registries, are
potentially important sources of performance information, but currently
only selected device types are studied, and the lack of standardization in
how information is collected and reported persists (Findings 5-6 and 5-7).
Finally, there is little collaboration in collection of postmarketing surveil-
lance data among the FDA, healthcare facilities, healthcare providers, the
medical-device industry, professional societies, payers, and patient-advocacy
groups (Finding 6-7).
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 on the market.
Recommendation 7-2 The Food and Drug Administration should
develop and implement a comprehensive strategy to collect, analyze,
and act on medical-device postmarket performance information.
The FDA should give high priority to postmarketing surveillance be-
cause it is an invaluable investment in short-term and long-term medical-
device safety oversight and assessment of device effectiveness. As discussed
in Chapter 5 of this report, the committee found that there was no long-term
strategy in the FDA to address the effectiveness of medical-device post-
marketing surveillance. The committee recommends that the FDA develop
a postmarketing surveillance strategy to meet the following objectives:
provide performance information for use in the premarket review process,
inform the development and use of postmarketing tools (that is, general and
special controls) to better manage the risk-benefit ratio throughout the life
cycle of devices, and inform the design of a new regulatory framework. To
meet those objectives, the FDA should
• xplore how to better understand potential device risks better with
E
existing postmarket tools, such as device tracking and Section 522
surveillance studies.
• xpand collaborative relationships with existing non-FDA medical-
E
device data sources and encourage standardization of processes and
systems to increase efficiency and the ability of all parties to use the
data.
• nstitutionalize integration of premarket and postmarket data
I
systems.
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200 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
• dentify methods for learning from independent clinical research
I
reported in the peer-reviewed literature on poor or adverse health
outcomes related to devices that may warrant FDA action.
• evise its strategy to communicate more effectively with consumers,
R
providers, and the public about problems with the performance of
medical devices.
The committee acknowledges that the traditional administrative and
clinical data sources used for surveillance of drugs may not be appropri-
ate for surveillance of medical devices, particularly surveillance of Class II
devices. Device surveillance will probably require other data sources, such
as unique device identifiers (discussed in Chapter 5).
Congress should support the capacity of CDRH’s postmarketing surveil-
lance programs by providing stable and adequate funding.
Postmarket Regulatory Authorities
When the FDA discovers violations of the law or products that pose
unacceptable risks to consumers, it has a wide variety of authorities (or
tools) available to remedy the situation and to sanction the violators. The
committee found that the agency uses these authorities sparingly (Findings
3-1 and 3-2). Although the committee identified the procedural require-
ments that the FDA must fulfill to exercise the authorities, the requirements
do not in themselves appear to explain CDRH’s perception that there are
“important limitations” on the use of postmarket tools.
Recommendation 7-3 The Food and Drug Administration should
review its postmarket regulatory authorities for medical devices to
identify existing limitations on their use and to determine how the
limitations can be addressed.
The appropriate use of postmarket regulatory authorities is an essential
component of a successful medical-device regulatory program. The FDA
should analyze barriers to efficient and effective use of these authorities and
identify means to mitigate the barriers. It is especially important that the
FDA be able to use the authorities, when needed, because a 510(k) decision
made by the FDA establishes a new predicate device that is legally binding
unless and until the agency has rescinded the decision or has barred the
device covered by that decision from the market through other legal actions
(Finding 2-3).
If required, Congress should pass legislation to remove unnecessary
barriers to the FDA’s use of postmarket regulatory authorities.
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CONCLUSIONS AND RECOMMENDATIONS
A Modified De Novo Process
The committee believes that the de novo process offers a potential basis
of a better regulatory model for premarket review of Class II devices. In its
current state, however, the de novo process is time-consuming and difficult
for both the FDA and manufacturers to navigate (Finding 4-9).
Recommendation 7-4 The Food and Drug Administration should
investigate the viability of a modified de novo process as a mecha-
nism for evaluating the safety and effectiveness of Class II devices.
A pilot program of a modified de novo process would allow the FDA
to determine the feasibility of the modified process as a replacement for the
510(k) clearance process. The 1976 MDA states that general controls alone
are not sufficient to ensure the safety and effectiveness of Class II devices.
Therefore, as part of a modified de novo process, the FDA should explore
ways to expedite development of special controls, develop guidances, and
adopt standards for devices. The agency also should consider expanded use
of external expertise and preinvestigational device exemption meetings with
submitters and use of conditional clearances for devices on which there is
little premarket performance information (such as a clearance conditioned
on postmarketing surveillance or use of registries).
The success of the modified de novo process will depend on CDRH’s
ability to develop a rich database on its processes and performance. There-
fore, it is imperative that CDRH develop a comprehensive information-
technology strategy based on an assessment of program needs and practices.
A Continuous Quality-Improvement Program
The committee’s assessment of the 510(k) clearance process showed that
CDRH’s operations lack a continuous quality-assurance process (Finding
3-5). CDRH’s Task Force on the Utilization of Science in Regulatory Deci-
sion Making found that the center did not have a process for addressing
the use of new types of scientific information in regulating medical devices
(FDA, 2010b). Lack of such a process prevents CDRH from effectively ad-
dressing new issues as they arise and from developing a long-term vision
of the center and its mission. For example, the Government Accountability
Office found that CDRH does not have a comprehensive information-
technology strategic plan that would allow it to meet its needs as it modern-
izes (GAO, 2009b).
Recommendation 7-5 The Food and Drug Administration should de-
velop and implement a program of continuous quality-improvement
to track regulatory decisions on medical devices, identify potential
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202 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
process improvements in the medical device regulatory framework,
and address emerging issues that affect decision-making.
Throughout the report, the committee identifies evidence that the inad-
equate information technology and management infrastructure in CDRH af-
fects not only the 510(k) program but also the center’s other programs. For
example, because data systems in the FDA are inadequate, the agency does
not have the ability to trace the history of 510(k) decisions (Finding 4-2).
Those 510(k) clearances are legally binding on CDRH for making future
decisions about devices going through the 510(k) clearance process. Thus,
any unsafe or ineffective devices are embedded in the system and as both a
legal and a practical matter may be used as predicates for new products until
they are removed from the market. Removing those devices from the market
may be difficult because there is no systematic way to identify them. By
developing a business model grounded in continuous quality-improvement,
CDRH will be able to identify problems and develop the information and
capacity to address them in a data-driven, transparent manner.
Facilitating Innovation in the Medical-Device Industry
As stated above, the committee believes that the FDA’s role in facilitat-
ing innovation with respect to Class II devices is to create and enforce a regu-
latory framework where the threshold to market provides reasonable assur-
ance that medical devices are safe and effective throughout their life cycle
while permitting timely entry of new devices that may offer improvements
over already marketed devices. The committee did not find assessments of
how much and in what way (that is, facilitating or inhibiting) innovation is
influenced by the 510(k) clearance process (Finding 6-6).
Recommendation 7-6 The Food and Drug Administration should
commission an assessment to determine the effect of its regulatory
process for Class II devices on facilitating or inhibiting innovation
in the medical-device industry.
The recommended study should include various ways to measure in-
novation beyond “time to market” or the number of devices of a particular
type on the market and instead focus on a broader understanding of the
relationship among regulation, innovation, and patient health and safety
throughout the device life cycle. There should be analysis of how incremen-
tal changes in existing devices affect clinical use, safety, and effectiveness;
characterization of research and development costs for truly innovative
technologies that enhance healthcare quality, efficiency, or access; estimates
of the effects of government interventions (for example, subsidies, mar-
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CONCLUSIONS AND RECOMMENDATIONS
ket exclusivity, and research support); and description of the current and
foreseeable relationship between FDA clearance or approval and payers’
willingness to reimburse for devices.
Software
Because of software’s important differences from hardware (as discussed
in Chapter 6), the FDA should develop a better understanding of the roles
that software plays in medical devices, analyze their potential effects on the
safety and effectiveness of the devices, and insist on evidence-based proce-
dures that ensure device safety and effectiveness. The committee believes
that the FDA should review and update its guidance on software validation.
Updating the guidance is important given the increasing use of software
in devices and as devices (for example, medical device data systems), the
integration in medical devices of commercial software not intended for
use in them, the increasing uncertainty introduced by device complexity,
and potentially unsafe interactions with other software systems. Reliance
on “best practices” is no longer sufficient, particularly when best-practice
recommendations often lag behind rapid change in software innovation.
The FDA should commission an independent study focused on addressing
these questions and concerns about software in medical devices. The study
should include not only an analysis of potential system problems introduced
by software but also recommendations about how the FDA can evaluate a
device’s software with respect to safety, dependability, security, reliability,
and privacy.
As suggested in a National Research Council study about ensuring
software dependability (NRC, 2007), the FDA should develop an evidence-
based approach for use by the medical-device industry to support its claims
of safety and effectiveness. Thus, one output of the present committee’s
recommended study should be evidential guidance to industry: What should
be reported to demonstrate safety and dependability?
At present, most available information about safety and effectiveness of
devices relies only on recall data; there is little specificity about the contribu -
tion of software to failures that lead to recalls. Thus, it is not always possible
to understand the particular contribution of software to device quality and
function; neither is it clear what oversight is needed in the premarket review
process. Moreover, because software engineers learn as much from failure
as from success, the scope of device-related reporting should be broadened
to include not only information about software-related device failures but
also descriptions of near-failures: What happened, why it happened, and
what can be done to prevent such problems in the future? The information
gained from such surveillance can inform the design and development of
new or modified software and the review of premarket submissions.
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204 MEDICAL DEVICES AND THE PUBLIC’S HEALTH
Recommendation 7-7 The Food and Drug Administration should
develop procedures that ensure the safety and effectiveness of soft-
ware used in devices, software used as devices, and software used
as a tool in producing devices.
Preamendment 510(k)-Eligible Class III Devices
After 35 years, the FDA has not completed the task of calling for PMAs
for or reclassifying preamendment Class III device types. Until the FDA
completes that task, those devices are allowed to enter the market through
the 510(k) clearance process (Finding 4-7). Congress in 1990 directed the
FDA to complete that task in a timely manner.2 Currently 25 device types
remain eligible to enter the market through the 510(k) process. The FDA
has begun a five-step process to require PMAs or to reclassify those device
types to a lower class (GAO, 2011). As of April 2011, the FDA has assessed
the risks and benefits associated with 21 device types (step 2 of the process)
and has received and reviewed public comments on 5 device types (step 4
of the process). The agency has issued a final rule for one of the 26 device
types (FDA, 2011). The committee recognizes the resource constraints that
have prolonged this process, but it nevertheless urges the FDA to give high
priority to completing this task.
Recommendation 7-8 The Food and Drug Administration should
promptly call for PMA applications for or reclassify Class III de-
vices that remain eligible for 510(k) clearance.
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