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Medical Device Recalls and the FDA Approval Process

Authors:
  • 35.91
  • National Center for Health Research

Abstract

Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk. We analyzed the FDA's high-risk List of Device Recalls from 2005 through 2009. Using FDA data, we determined whether the recalled devices were approved by the more rigorous (PMA) process, the 510(k) process, or were exempt from FDA review. There were 113 recalls from 2005 through 2009 that the FDA determined could cause serious health problems or death. Only 21 of the 113 devices had been approved through the PMA process (19%). Eighty were cleared through the 510(k) process (71%), and an additional 8 were exempt from any FDA regulation (7%). Cardiovascular devices comprised the largest recall category, with 35 of the high-risk recalls (31%); two-thirds were cleared by the 510(k) process (66%; n = 23). Fifty-one percent of the high-risk recalls were in 5 other device categories: general hospital, anesthesiology, clinical chemistry, neurology, or ophthalmology. Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices.
ONLINE FIRST |HEALTH CARE REFORM
ORIGINAL INVESTIGATION
Medical Device Recalls and the FDA Approval Process
Diana M. Zuckerman, PhD; Paul Brown, BS; Steven E. Nissen, MD
Background:Unlike prescription drugs, medical de-
vices are reviewed by the US Food and Drug Adminis-
tration (FDA) using 2 alternative regulatory standards:
(1) premarket approval (PMA), which requires clinical
testing and inspections; or (2) the 510(k) process, which
requires that the device be similar to a device already mar-
keted (predicate device). The second standard is in-
tended for devices that the FDA deems to involve low or
moderate risk.
Methods:We analyzed the FDA’s high-risk List of De-
vice Recalls from 2005 through 2009. Using FDA data,
we determined whether the recalled devices were ap-
proved by the more rigorous (PMA) process, the 510(k)
process, or were exempt from FDA review.
Results:There were 113 recalls from 2005 through 2009
that the FDA determined could cause serious health prob-
lems or death. Only 21 of the 113 devices had been ap-
proved through the PMA process (19%). Eighty were
cleared through the 510(k) process (71%), and an addi-
tional 8 were exempt from any FDA regulation (7%). Car-
diovascular devices comprised the largest recall cat-
egory, with 35 of the high-risk recalls (31%); two-thirds
were cleared by the 510(k) process (66%; n=23). Fifty-
one percent of the high-risk recalls were in 5 other de-
vice categories: general hospital, anesthesiology, clini-
cal chemistry, neurology, or ophthalmology.
Conclusions:Most medical devices recalled for life-
threatening or very serious hazards were originally cleared
for market using the less stringent 510(k) process or were
considered so low risk that they were exempt from re-
view (78%). These findings suggest that reform of the
regulatory process is needed to ensure the safety of medi-
cal devices.
Arch Intern Med.
Published online February 14, 2011.
doi:10.1001/archinternmed.2011.30
IN1938, WHEN THE US CONGRESS
first mandated that medical prod-
ucts demonstrate safety and ef-
fectiveness, the law applied only
to drugs, not to medical devices.
Congress did not give the US Food and
Drug Administration (FDA) the author-
ity to regulate all medical devices until
1976, when it amended the Food, Drug,
and Cosmetics Act in response to deaths
and infertility caused by the Dalkon Shield
and other contraceptive intrauterine de-
vices. Congress and the FDA weighed
2 competing goals during passage of this
legislation: providing “the public reason-
able assurances of safe and effective de-
vices”1(p1339) while avoiding “overregula-
tion”1(p1339) of the industry.
The 1976 law included a premarket ap-
proval (PMA) process for devices that is
similar to the new drug application pro-
cess used for pharmaceuticals. Submis-
sions for PMA require extensive testing,
including “valid scientific evidence”2(p2)
that “provide[s] reasonable assurance that
the device is safe and effective for its in-
tended use.”2(p2) The PMA process was de-
veloped as the approval pathway for medi-
cal devices that “support or sustain human
life, are of substantial importance in pre-
venting impairment of human health, or
which present a potential, unreasonable
risk of illness or injury.”2(p2)
Thousands of devices were already mar-
keted in 1976, so Congress included an al-
ternative pathway to the PMA known as
the 510(k) provision, which was in-
tended to provide a less burdensome route
to enable newer versions of existing de-
vices to enter the market. The 510(k) path-
way did not require clinical trials or manu-
facturing inspections to demonstrate safety
and efficacy. Instead, the sponsor was re-
quired only to demonstrate that the de-
vice was substantially equivalent in mate-
rials, purpose, and mechanism of action
to another device that was already on the
market in May 1976. The previous de-
See Invited Commentary
at end of article
Author Affiliations: National
Research Center for Women &
Families, Washington, DC
(Dr Zuckerman and Mr Brown);
Department of Cardiovascular
Medicine, Cleveland Clinic,
Cleveland, Ohio (Dr Nissen).
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vice served as the predicate device with which the new
one would be compared. This approach was justified as
a way to give manufacturers the opportunity to make small
improvements on the devices already on the market and
to allow companies with new products to compete with
very similar devices without using the more extensive
PMA process. If the FDA determined that the product
was reasonably safe and effective according to the 510(k)
review, it was said to be cleared for market rather than
approved.
Former FDA officials explain that in 1976, relatively
few medical devices were permanently implanted or in-
tended to sustain life.3The 510(k) process was specifi-
cally intended for devices with less need for scientific scru-
tiny, such as surgical gloves and hearing aids. At first,
510(k) reviews were easy for the FDA to conduct be-
cause the new devices were so similar to the devices al-
ready on the market, but the system was quickly chal-
lenged as new devices changed more dramatically and
became more complex.3The FDA did not have the re-
sources to develop performance standards for new mod-
erate-risk devices or to shift more devices to the much
more stringent and time-consuming PMA process.3
Instead, the opposite trend occurred. In an era of ag-
gressive deregulation, the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA) was passed by
Congress, signed by President Bush, and interpreted by
the FDA to shift the regulatory standard to “the least bur-
densome approach in all areas of medical device regula-
tion.”4(p4) Subsequently, the definition of substantially
equivalent was modified to include products made from
different materials and using a different mechanism of
action if they were determined to have a similar safety
profile. Since clinical trials are not required for 510(k)
clearance, approval of devices would be based on bio-
materials testing or other standards. Furthermore, predi-
cate devices no longer were limited to products already
on the market prior to May 1976 but could include de-
vices cleared through the 510(k) or PMA process. In re-
cent years, the FDA has used the 510(k) provision as the
dominant mechanism for new device clearance, review-
ing only 1% of medical devices by its more rigorous PMA
process.5The present study was designed to examine how
often the different approval or clearance processes were
used for medical devices that were subsequently re-
called for life-threatening problems.
METHODS
FDA CLASSES OF DEVICES AND
STANDARDS OF CLEARANCE
For this study, we based our analysis on FDA assignments of
medical devices to 1 of 3 classes “based on the level of control
necessary to assure the safety and effectiveness of the de-
vice”6(p1) and on the level of risk the device poses to patients.
Class I devices involve the lowest risk and include items such
as tongue depressors, bandages, and crutches. Class II de-
vices, such as electrocardiographs, contact lens solutions, hear-
ing aids, and drills for orthopedic applications, involve inter-
mediate risk. And Class III devices are defined by the FDA to
pose the greatest potential risk and include such items as im-
plantable pacemakers, stents, heart valves, and human immu-
nodeficiency virus diagnostic tests. Although implants and de-
vices that prevent impairment of health are supposed to be Class
III, many hip and knee implants are designated as Class II.
Most Class I devices and some Class II devices are exempt
from premarket review and most good manufacturing prac-
tices regulations.6Companies need not apply to the FDA for
review or clearance for exempt devices but merely need to no-
tify the FDA that they are selling the products. Class II devices
considered to pose intermediate risk are reviewed through the
510(k) premarket notification process. Class III devices, which
are implantable or life-sustaining devices, were intended by law
to require the more rigorous PMA review process.5
In 2007, Congress asked the Government Accountability Of-
fice (GAO) to review the 510(k) process. The resulting 2009
GAO report described the 510(k) process as less stringent, faster,
and less expensive than the PMA process and concluded that
66% of Class III submissions cleared through the 510(k) pro-
cess in recent years were “implantable, life sustaining, or of sig-
nificant risk,”5(p21) which the GAO pointed out by law should
have been reviewed through the more rigorous PMA process
instead.5The GAO noted that while the FDA had committed
to stop clearing Class III devices through the 510(k) process
more than 14 years earlier, the agency continued this prac-
tice.5In addition, the GAO reported that of the 10 670 submis-
sions for Class II devices that the FDA cleared through the 510(k)
process, “FDA’s databases identified one-quarter as being for
devices that were implantable; were life sustaining; or pre-
sented significant risk to the health, safety, or welfare of a pa-
tient.”5(p18) The GAO also pointed out that these devices should
have been subjected to the more stringent PMA process.
STUDY DESIGN AND MAIN
OUTCOME MEASURE
Using data available on the FDA Web site (www.fda.gov), we
analyzed how often the FDA issued high-risk recalls of medi-
cal devices cleared through the various FDA processes: the more
rigorous PMA process, the 510(k) process, or exempt from FDA
review. We started with the devices on FDA’s List of Device
Recalls,7which includes only devices about which the FDA con-
cluded “there is a reasonable chance that they could cause se-
rious health problems or death.”7(p1) For each device on this
high-risk recall list from 2005 through 2009, we used the FDA
Web site link to product information to determine the process
the FDA used to initially review or register the device.
RESULTS
From January 2005 through December 2009, the FDA
included 115 names of recalled devices (involving mil-
lions of units) on their high-risk recall list. Of these 115
recalls, the FDA designated 113 as Class I recalls, which
the FDA defines as the highest risk based on informa-
tion provided to the FDA by health professionals, re-
searchers, patients, or device companies. In fiscal year
2006, for example, the FDA received reports of 116 086
potential device-related injuries, 2830 potential device-
related deaths, and more than 200 000 adverse event re-
ports concerning medical devices.8The FDA uses these
reports to help determine whether a device should be re-
called because of a high risk to patients.
The PMA process was used to approve only 21 of the
113 devices listed as high-risk recalls that could cause
serious health problems or death (19%).7Eighty were
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cleared through the 510(k) process (71%), and an addi-
tional 8 were completely exempt from FDA regulation
and were merely registered with the FDA(7%). In addi-
tion, four were counterfeit devices or categorized as
“other” (4%) and did not go through any of the 3 pro-
cesses for approval, clearance, or registration (Figure 1).
Cardiovascular devices comprised the largest recall
category, with 35 separate recalls accounting for 31% of
devices on the FDA’s high-risk recall list (Figure 2).
Two-thirds of these recalled cardiovascular devices were
cleared by the 510(k) process (66%; n=23), while 34%
were approved through the PMA process (n=12).
Despite the FDA law that requires almost all Class III
devices to be approved through the more stringent PMA
process, 13 of the 510(k) high-risk recalled devices were
designated as Class III devices (12%). All of these
recalled devices were used for treating cardiovascular
disease. Most were automated external defibrillators
(AEDs) approved for resuscitation of patients in cardiac
arrest (Table). Researchers have reported that more
than 20% of the almost 1 million AEDs in circulation
were recalled by the FDA, and hundreds of people died
due to AED malfunctions.9
The second largest high-risk recall category (24 % of the
total) was made up of 27 general hospital devices, includ-
ing insulin pumps, intravenous infusion devices, and pa-
tient lifts. Seventy-four percent of these recalled devices were
cleared through 510(k) review (n=20) and only 22 % were
approved through the more rigorous PMA process (n=6).
The third largest high-risk recall category (10 % of the
total) was anesthesiology devices, including mechanical ven-
tilators. All of these devices were cleared by the 510(k) pro-
cess (10 devices) or were exempt from review (1 device).
The fourth and fifth largest categories of high-risk re-
calls were clinical chemical analysis and neurologic de-
vices, respectively. Nine percent of all recalls were clini-
cal chemical analysis devices such as glucose meters and
other diagnostic testing equipment (n=10). These de-
vices were cleared by the 510(k) process (7 devices, 70%),
were exempt from review (1 device, 10%), or were not
approved or cleared at all because they were counterfeit
or in the other category (2 devices, 20%). Five percent
of the high-risk recalls were neurologic devices (n=6),
which included shunts and devices for the face, jaw, and
cranium. One device was counterfeit and therefore was
neither approved nor cleared; the remaining 5 of these
recalled devices were cleared by the 510(k) process (83%).
None was approved through the PMA process.
Only 3 devices of the high-risk recalls were in the oph-
thalmic category (3%). However, this category had the
highest number of units recalled—57 254 133—with al-
most all units from the recall being 1 contact lens solu-
tion (COMPLETE MoisturePLUS multi-purpose con-
tact lens solution; Advanced Medical Optics Inc, Santa
Ana, California).10 This lens solution was recalled when
some users contracted parasitic eye infections that re-
sulted in blindness or required a corneal transplant.
80
60
70
50
10
20
30
40
0
PMA 510(k) 510(k)
Exempt
Counterfeit
or Other
High-Risk Recalled Devices, %
Figure 1. High-risk recalled devices classified by how the US Food and Drug
Administration reviewed them from 2005 through 2009. PMA indicates
premarket approval; 510(k), the less stringent premarket notification
process.
35
25
5
15
10
20
30
0
Anesthesiology
Clinical Chemistry
Cardiovascular
General Hospital
Neurology
Other
High-Risk Recalled Devices, %
Figure 2. High-risk recalled devices categorized by medical specialty
designated by the US Food and Drug Administration.
Table. High-Risk Recalls of Class III Devices
Cleared Through 510(k)
Date Recalled Device
July 31, 2009 LIFEPAK CR Plus AED (Physio-Control Inc,
Redmond, Washington)
February 12,
2009
AED Plus (ZOLL Medical Corporation, Chelmsford,
Massachusetts)
February 2,
2009
Intra-aortic balloons (30, 40, and 50 mL) (Teleflex
Medical, Research Triangle Park, North Carolina)
December 15,
2008
AED 10 and MRL Jumpstart AED (Welch Allyn Inc,
Skaneateles Falls, New York)
August 28, 2008 LIFEPAK CR Plus AED (Physio-Control Inc)
March 17, 2008 CentriMag Extracorporeal Blood Pumping System
including CentriMag Primary Console (Levitronix
LLC, Waltham, Massachusetts)
October 26,
2007
AED 10 (Welch Allyn Inc)
August 24, 2007 AED 20 (Welch Allyn Inc)
February 17,
2007
Lifeline AED and ReviveR AED (Defibtech LLC,
Guilford, Connecticut)
June 15, 2006 AED 20 (Welch Allyn Inc)
April 28, 2005 AED 20 (Welch Allyn Inc)
February 14,
2005
Samaritan AEDs (various models) (HeartSine
Technologies Inc (Newtown, Pennsylvania)
February 3,
2005
LIFEPAK 500 AED (certain models) (Medtronic,
Redmond, Washington)
Abbreviations: AED, Automated external defibrillator; 510(k), the less
stringent premarket notification process.
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COMMENT
The present analysis demonstrates that most of the medi-
cal devices recalled by the FDA owing to serious risks dur-
ing the past 5 years were approved through the 510(k) regu-
latory process or were completely exempt from regulatory
review (78%). As such, these devices did not undergo clini-
cal testing or premarket inspections, nor were postmar-
ket studies required to determine safety and efficacy. While
even the more rigorous PMA criteria for device approval
are often scientifically inadequate to ensure patient safety,11
PMA standards are clearly superior to 510(k) standards.
Of the recalled devices cleared for market through the
510(k) process, 12% were marketed for risky or life-
sustaining Class III indications, which are required by law
to undergo a full PMA regulatory review. The devices re-
called owing to high risks spanned a broad range of clini-
cal applications, but cardiovascular devices represented the
most common category (31%) (Figure 2). These findings
demonstrate systematic problems in the implementation
of existing medical device regulations that have exposed
patients to serious harm.
The FDA’s implementation of the 510(k) process has
received considerable criticism from public health advo-
cates and from other federal agencies in reports, medical
journal articles, and testimony before Congress.5,9,12,13 Sev-
eral months after the GAO’s critical report in January 2009,
the FDA requested that the Institute of Medicine con-
duct an independent outside review (currently under way)
of the 510(k) process.14 Subsequently, in August 2010,
the FDA released an internal report that suggested nu-
merous changes intended to strengthen and clarify the
510(k) process.15
In that August 2010 report, the FDA 510(k) Working
Group acknowledged that “in recent years, concerns have
been raised within and outside of FDA about whether the
current 510(k) program optimally achieves [the] goals”15(p3)
of ensuring that devices are safe and effective and foster-
ing innovation in the medical device industry. The FDA
report suggested that clinical trials should be required in
more 510(k) reviews and that safety would be enhanced
if the FDA had expanded authority to require premarket
inspections and postmarket studies as a condition of clear-
ance. AdvaMed,16,17 the largest association representing
medical device manufacturers, opposes these changes.
One reason that the FDA has relied heavily on the 510(k)
process is because it is less expensive and enables the rela-
tively small Center for Devices and Radiological Health
(CDRH) to review thousands of devices each year. For ex-
ample, in 2005, the average cost for the FDA to review a
510(k) submission was estimated at $18 200, while a PMA
submission cost the agency $870 000 to review.5The Con-
gress has not appropriated sufficient funds to the CDRH
to use the more expensive PMA process for most devices,
and this large cost differential creates an incentive for CDRH
to rely heavily on the 510(k) process. The FDA is partially
supported by industry user fees, but the FDA charges much
smaller user fees to review medical devices than it charges
to review prescription drugs, even for the largest compa-
nies. In 2010, the FDA charged a standard fee of $4007
for a 510(k) submission (and only half that amount for
small companies) and $217 787 for an original PMA (one-
quarter that amount for small companies)18 compared with
$702 750 to $1 405 500 for prescription drug applica-
tions.19 The PMA user fees provide less than one-fourth of
the $870 000 average cost of the review in terms of FDA
staff and resources, creating a disincentive for the FDA to
select the PMA process. As part of the reauthorization of
the FDA law that requires user fees, the FDA is currently
holding meetings with pharmaceutical and device com-
panies to consider changes in user fees for drugs and
devices.20,21
In addition to not requiring clinical trials, there are 3
other aspects of the 510(k) process that are much less
stringent than the PMA process: (1) under 510(k), the
FDA does not generally require premarket inspections
of how the devices were manufactured5; (2) the FDA does
not require postmarket studies as a condition of clear-
ance22; and (3) the FDA has much more limited author-
ity to rescind or withdraw clearance of a 510(k) device
that is found to be unsafe or ineffective.23
The US courts have recognized the shortcomings of the
510(k) process. In Lohr vs Medtronic Inc, the US Court of
Appeals for the 11th Circuit in 1995 stated “The 510(k)
process is focused on equivalence, not safety, and the ques-
tion of whether a device has been deemed safe and effec-
tive cannot be resolved by looking at the 510(k) process
[emphasis in the original].”1(p1348) In 1996, the Supreme
Court affirmed the 11th Circuit conclusions that “[s]ince
the § 510(k) process is focused on equivalence, not safety,
substantial equivalence determinations provide little pro-
tection to the public [emphasis in the original].”24(p493)
In an analysis funded by AdvaMed, a Batelle report re-
cently concluded that the 510(k) process was adequate be-
cause the number of high-risk recalls represents a small
proportion of devices cleared through the 510(k) pro-
cess.25 However, that analysis did not take into account
the public health implications for patients and the US medi-
cal system. As noted herein, FDA data and previous stud-
ies in medical journals indicate that high-risk recalled
510(k) devices were used by tens of millions of patients,
exposing them to potential harm and adding substantial
costs to medical care. On a policy level, the present analy-
sis and the 2009 GAO analysis5indicate that the FDA is
not fully implementing the law that requires high-risk medi-
cal devices to be approved through the PMA process and
frequently uses the 510(k) process instead.
An important question is whether the risks resulting
from subsequently recalled devices could have been pre-
vented if the 510(k) or exempt devices had been subject
to a more rigorous review process. Clinical trials and other
more rigorous premarket data collection required in the
PMA process but not the 510(k) process could uncover
design flaws or manufacturing flaws before a device is
sold. Premarket inspections, which are required for PMA
devices but rarely used as part of the current 510(k) re-
view process, could also uncover manufacturing flaws that
result in products that are less safe or less effective for
patients and consumers. Requiring postmarket studies
as a condition of approval, which is an option for PMA
approval but not usually for 510(k) clearance, could help
determine risks sooner than the current adverse-event
reporting system.
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CONCLUSION
Medical devices cleared through the less rigorous 510(k)
pathway comprise more than two-thirds of the products
that are recalled by the FDA because they could seri-
ously harm patients or result in death. When devices that
were intentionally exempt from any FDA review were
added to the 510(k) devices, they comprise more than 3
out of 4 of the high-risk recalls during the last 5 years.
Thus, the standards used to determine whether a medi-
cal device is a high-risk or life-sustaining product prior
to approval are clearly very different from the standards
used to recall a medical device as life threatening. Our
findings reveal critical flaws in the current FDA device
review system and its implementation that will require
either congressional action or major changes in regula-
tory policy.
The results of the present analysis indicate that the
number of high-risk recalls of medical devices and the
number of patients affected by these recalls would be sub-
stantially decreased if the following changes were made
in the FDA process:
1. The FDA fully implements current law that sub-
jects “life-saving and life sustaining” (Class III) devices
to the PMA process;
2. The FDA’s definition of a high-risk device takes into
account the potential risks if the device fails;
3. The FDA expands the use of their authority to in-
spect the manufacturing of 510(k) devices just as they
do for devices approved through the PMA process; and
4. The FDA strengthens their authority to use spe-
cial controls for 510(k) devices as they do for PMA de-
vices, such as postmarket surveillance, performance stan-
dards, and product-specific and general guidance
documents.
Accepted for Publication: December 9, 2010.
Published Online: February 14, 2011. doi:10.1001
/archinternmed.2011.30
Correspondence: Diana M. Zuckerman, PhD, National Re-
search Center for Women & Families, 1001 Connecticut
Ave, NW, Ste 1100, Washington, DC 20036 (dz
@center4research.org).
Author Contributions: Study concept and design: Zuck-
erman and Brown. Acquisition of data: Brown. Analysis
and interpretation of data: Zuckerman, Brown, and Nis-
sen. Drafting of the manuscript: Zuckerman and Brown.
Critical revision of the manuscript for important intellec-
tual content: Zuckerman and Nissen. Statistical analysis:
Zuckerman and Nissen. Administrative, technical, and ma-
terial support: Brown and Nissen. Study supervision: Zuck-
erman and Brown.
Financial Disclosure: Dr Zuckerman owns stock in
Johnson & Johnson. Dr Nissen consults for many phar-
maceutical companies but requires them to donate all
honoraria or consulting fees directly to charity so that
he receives neither income nor a tax deduction for his
services. The Cleveland Clinic Center for Clinical Re-
search has received funding to perform clinical trials from
Pfizer, Astra Zeneca, Novartis, Novo Nordisk, Roche, Daii-
chi-Sankyo, Karo Bio, Takeda, Sanofi-Aventis, Resver-
logix, and Eli Lilly. Dr Nissen is involved in these clini-
cal trials, but he receives no personal remuneration for
his participation.
Funding/Support: This study was funded by individual
donations to the National Research Center for Women
& Families, which does not accept contributions from
medical device companies.
Additional Contributions: Research assistants Sharon
Cannistra, BA, Heidi Mallis, MPH, Padma Ravichan-
dran, BS, and Meredith L. Van Tine, JD, provided valu-
able help with the data collection and analysis.
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9. Maisel WH. Medical devices: are current regulations doing enough for
patients? testimony before the Subcommittee on Health, Committee on
Energy and Commerce, House of Representatives: June 2009. http:
//energycommerce.house.gov/index.php?option=com_content
&view=article&id=1677. Accessed August 31, 2009.
10. US Food and Drug Administration. Medical & radiation emitting device recalls.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=52779. Ac-
cessed March 2, 2010.
11. Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the
FDA in premarket approval of cardiovascular devices. JAMA. 2009;302(24):
2679-2685.
12. Zuckerman D. Testimony on reauthorization of the Medical Device User Fee and Mod-
ernization Act before the Subcommittee on Health, Committee on Energy and Com-
merce, House of Representatives: May 2007. http://archives.energycommerce.house
.gov/cmte_mtgs/110-he-hrg.051607.Zuckerman-Testimony.pdf. Accessed November
9, 2010.
13. Redberg RF. Medical devices and the FDA approval process: balancing safety
and innovation; comment on “prevalence of fracture and fragment embolization
of bard retrievable vena cava filters and clinical implications including cardiac
perforation and tamponade.” Arch Intern Med. 2010;170(20):1831-1833.
14. US Food and Drug Administration. Public health effectiveness of the FDA 510(k)
clearance process: balancing patient safety and innovation: workshop report, October
14, 2010. http://www.books.nap.edu/openbook.php?record_id=12960&page=1.
Accessed January 13, 2011.
15. US Food and Drug Administration. CDRH preliminary internal evaluations—
volume I: 510(k) working group, preliminary report and recommendations. Au-
gust 2010. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH
/CDRHReports/UCM220784.pdf. Accessed August 17, 2010.
16. AdvaMed. AdvaMed statement on FDA public meeting (press release). October
2010. http://www.advamed.org/MemberPortal/About/NewsRoom/NewsReleases
/PR-FDA510K-10810.htr. Accessed November 9, 2010.
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17. Medical Device Industry Applauds Lawmaker Concern Over Review Process. CQ
Healthbeat News. October 13, 2010.
18. Federal Register. Medical device user fee rates for fiscal year 2010: Docket No.
FDA-2009-N-0338: August 2009. http://edocket.access.gpo.gov/2009/E9-18456
.htm. Accessed June 21, 2010.
19. Federal Register. Prescription drug user fee rates for fiscal year 2010: Docket
No. FDA-2009-N-0339: August 2009. http://edocket.access.gpo.gov/2009
/E9-18457.htm. Accessed June 18, 2010.
20. Federal Register. Prescription Drug User Fee Act; public meeting: docket No. FDA-
2010-N00128: March 2010. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi
?dbname=2010_register&docid=fr16mr10-68.pdf. Accessed August 18, 2010.
21. Federal Register. Medical Device User Fee Act; public meeting: Docket No. FDA-
2010-N00389: August 2010. http://edocket.access.gpo.gov/2010/2010-19843
.htm. Accessed August 13, 2010.
22. Rosecrans HS. FDA’s 510(k) workshop: issues related to postmarket surveil-
lance and new information about marketed devices: February 2010. http://www
.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences
/UCM201345.pdf. Accessed March 2, 2010.
23. Tillman D-B. Understanding the premarket notification 510(k) process: FDA’s 510(k)
working group presentation to the Institute of Medicine: March 2010. http://www
.iom.edu/~/media/Files/Activity%20Files/PublicHealth/510kProcess/2010-MAR-01
/Tillman-The%20510k%20Working%20Group.ashx. Accessed November 9, 2010.
24. Medtronic Inc v Lohr, 518 US 470 (1996). http://scholar.google.com/scholar_case
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_sdt=2,9. Accessed January 13, 2011.
25. McCarty M. Batelle says 510(k) recalls since ’98 are at less than 1%. http://www
.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher
?next=bioWorldHeadlines_article&forceid=72862. Accessed November 9, 2010.
ONLINE FIRST
INVITED COMMENTARY
Medical Device Recalls
Get It Right the First Time
Consumers are justifiably upset when their cars,
toasters, and baby food bottles are recalled. Re-
calls make us all question the safety of the prod-
ucts we take for granted. But what about the products
permanently implanted inside our bodies? Surely they
have been sufficiently tested to ensure that no one will
need to bring their thorax to the shop for removal and
replacement. It is sad and troubling to learn that we can-
not count on this assurance for some medical devices.
Medical devices are divided into 3 classes by the FDA,
according to their level of risk to patients.1Class I de-
vices pose a low risk, present minimal potential harm to
patients (items such as stethoscopes and bandages), and
are subject to minimal regulation. Class II devices pose
a moderate risk, include such items as hearing aids and
wheelchairs, and may be cleared through the 510(k) pre-
market notification process, whereby they can be mar-
keted if they are substantially equivalent to a predicate
device. Importantly, clinical trials are not necessary for
these 2 device classes.
Class III devices, such as stents and implantable car-
dioverter-defibrillators, pose a potential high risk and are
defined as those devices that “support or sustain human
life, are of substantial importance in preventing impair-
ment of human health, or which present a potential, un-
reasonable risk of illness or injury.”1The FDA states that
“Premarket approval (PMA) is the required process of sci-
entific review to ensure the safety and effectiveness”1of
these devices
A 2009 GAO report of all FDA reviews of high-risk
devices in fiscal years 2003 through 20072found that more
high-risk devices get cleared via the 510(k) than through
the original PMA process. Simply put, this means that
more often than not, the highest-risk devices are being
approved, marketed, and used in patients without any
clinical trial data. Therefore, although the FDA commit-
ted some time ago to require that high-risk devices be
either evaluated through PMA or reclassified to a lower
risk class, neither has yet occurred. Indeed, it has been
over 20 years since Congress passed the Safe Medical De-
vices Act, envisioning that this would happen.2How-
ever, currently, only 1% of all devices go through PMA.
Zuckerman and colleagues demonstrate the dangers
to patient safety posed by these innumerable device mis-
classifications. They review the approval pathway for all
high-risk recalls of medical devices from 2005 through
2009. Although high-risk device recalls are defined as
those that could cause serious health problems or death,
more than three-fourths of these potentially lethal de-
vices were not approved by PMA. Instead, most were
cleared through the weaker 510(k) process, which does
not require any clinical data on safety or effectiveness be-
fore or after approval. A few were even considered ex-
empt from review. Ultimately, this means that devices
not considered during the approval process to pose a po-
tentially high risk might still be subject to a high-risk re-
call. This paradox presents a critical safety concern.
Cardiovascular devices were the most common cat-
egory for high-risk recalls. For example, hundreds of
deaths have been attributed to AED malfunctions, while
it remains unclear how many lives these devices may have
saved. Another worrisome example is the Sprint Fidelis
(Medtronic, Minneapolis, Minnesota), an implantable car-
dioverter-defibrillator approved by the FDA in 2004 with-
out any premarket clinical testing.3It was subsequently
implanted in 268 000 patients over 3 years before being
voluntarily withdrawn by the manufacturer owing to the
possibility of lead fracture, which led to inappropriate
shocks or loss of function. Regrettably, by early 2009, the
manufacturer had already identified 13 patient deaths re-
lated to the defective leads.4
Undoubtedly, some recalls are unavoidable as our
knowledge and experience with a device grows. How-
ever, we must make sure that before devices are ap-
proved and widely disseminated, we have done due dili-
gence to determine that they are safe and effective. For
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... The supply chain process varies largely between product types (drug and device) and even within a product group. 4 Today, foreign outsourcing of a company's manufacturing process is more popular than ever, but this effort to cut costs comes at a price. 5 As the complexity of the supply chain increases, proper regulation and maintenance of high quality becomes more challenging. ...
... The 510(k) provision allows for Class I or II medical devices to be approved without clinical trials or manufacturing inspections of safety and efficacy. 4 Premarket approval costs for Class I and II medical devices are significantly cheaper ($18,200 vs $870,000) than the premarket approval process used for Class III medical devices. 4 In addition, medical device recalls are often very costly and deadly for the consumer because they are largely used in vivo. ...
... 4 Premarket approval costs for Class I and II medical devices are significantly cheaper ($18,200 vs $870,000) than the premarket approval process used for Class III medical devices. 4 In addition, medical device recalls are often very costly and deadly for the consumer because they are largely used in vivo. When a quality recall is issued for an in vivo medical device a separate operation to fix the device has to occur putting unnecessary risk and financial burden on the consumer. ...
Article
Objective Our objective was to review recent drug and medical device recalls, categorize recall types based on the free text descriptions posted within the recall announcements, and conduct exploratory analyses for researchers interested in pharmaceutical supply chain challenges. Methods A cross-sectional study of all current recalls, market withdrawals, and safety alerts published by the United States Food and Drug Administration pertaining to drugs was conducted. A manual review of all the recalls was also conducted to extract additional information including company details, recall type (labeling or quality), and location of failure in the pharmaceutical supply chain (manufacturing or distribution). Descriptive statistics and exploratory bivariate analyses were conducted to test any potential differences between drug and device recalls. Results Most recalls issued between January 2017 and September 2019 were pharmaceutical drug recalls (85.2%), while 34 (14.8%) medical device recalls were issued for the same period. For drug recalls, 85.1% (166/195) were because of quality, while 14.9% (29/195) were because of labeling issues. Of the quality issues for drug recalls, lack of sterility was the most frequent issue (139/166, 83.7%). There was no difference between drug or device recalls based on recall type (P = 0.16), top 20 pharmaceutical company (P = 0.62), or location of the supply chain failure (P = 0.20). Conclusions This study provides a process to categorize and evaluate drug and device recalls by recall type and location of the supply chain. By categorizing the free text provided in public recall data it would be easier to monitor trends over time.
... This relatively insignificant decrease is concerning. Zuckerman et al. determined that the less stringent 510(k) method contributed the largest percentage of devices recalled due to life-threatening hazards [27]. Thus, enacting more standardized and stringent reviews may reduce the percentage of recalls. ...
... Class III medical devices need to be approved through the PMA process as they carry the greatest potential risks. However, many high-risk orthopedic devices have been miscategorized under class II, bypassing the PMA requirements [27]. Between 1992 and 2012, nearly 94% of orthopedic devices were categorized as class II [11]. ...
Article
Full-text available
Introduction The medical device industry has grown substantially in recent years. There is limited research examining orthopedic subspecialties and the recall of orthopedic devices. We hypothesize that knee arthroplasty devices cleared through the Food and Drug Administration (FDA) 510(k)-notification process would have a higher recall rate than the premarket approval (PMA) process. Methods The FDA database was thoroughly queried for all knee arthroplasty surgical devices from January 1, 2007 through December 31, 2017. Recalled devices were analyzed by manufacturer, type of implant, recall class, manufacturer-determined reason, FDA-determined reason, quantity affected, submission type, and distribution within the United States or internationally. Results Out of over 30,000 medical devices on the market, a total of 300 knee arthroplasty devices from 18 different companies were recalled during the time frame of this study. Tibial components accounted for 35.33% of devices, polyethylene implants for 38.67%, and femoral components for 15%. The most common reason for recall was device design (n = 134, 44.67%), followed by process control (n = 32, 10.67%). Of the 300 knee arthroplasty devices recalled, 267 (89.0%) were cleared through the 510(k) premarket notification process and 33 (11.0%) devices were approved through the PMA process. Conclusions A larger proportion of knee arthroplasty surgical devices cleared through the 510(k) process were recalled compared to implants approved through the stricter PMA process. Changing the 510(k) process may enable manufacturers to improve upon the safety of their devices.
... The traditional framework for regulatory approval for medical devices employed by the FDA was focused on the risk-benefit balance and intended clinical use. 42 Truly novel devices may require a de novo pathway, although the majority of currently approved AI software underwent the 510(k) process after demonstrating that the algorithms represent a modification of an existing, previously approved device. Harvey et al 43 very recently published a comprehensive in-depth review of the current FDA framework and legislature determining the future regulatory approval process for AI algorithms. ...
... 45 According to their new approach, the FDA requires a commitment from manufacturers on transparency and real-world performance monitoring for AI-based software as a medical device. 42,45 Although the framework for this process is still under discussion, 46 the proposed software as a medical device pathway for software with self-learning abilities will very likely categorize modifications to such devices into one of the following classes 43 : (1) modifications to algorithm performance only (eg, retraining on additional data, for example, large chest CT datasets from other relevant regions), (2) input modification only (eg, additional data types, such as MRI correlation to improve performance of an abdominal CT algorithm detecting suspicious liver masses), or (3) modification to intended use (eg, different indication or patient collective, for example, teaching a pulmonary nodule algorithm that detects early-stage lung cancer to predict growth). ...
Article
Although artificial intelligence (AI) has been a focus of medical research for decades, in the last decade, the field of radiology has seen tremendous innovation and also public focus due to development and application of machine-learning techniques to develop new algorithms. Interestingly, this innovation is driven simultaneously by academia, existing global medical device vendors, and-fueled by venture capital-recently founded startups. Radiologists find themselves once again in the position to lead this innovation to improve clinical workflows and ultimately patient outcome. However, although the end of today's radiologists' profession has been proclaimed multiple times, routine clinical application of such AI algorithms in 2020 remains rare. The goal of this review article is to describe in detail the relevance of appropriate imaging data as a bottleneck for innovation, provide insights into the many obstacles for technical implementation, and give additional perspectives to radiologists who often view AI solely from their clinical role. As regulatory approval processes for such medical devices are currently under public discussion and the relevance of imaging data is transforming, radiologists need to establish themselves as the leading gatekeepers for evolution of their field and be aware of the many stakeholders and sometimes conflicting interests.
... This pathway is much more rapid and less expensive than the PMA mechanism. 48,49 The postmarket trials of the approved products tend to be company sponsored and are therefore biased, small and do not compare similar products head to head. Because the products are already on the market, the sponsors have little motivation to cover the huge costs of large, unbiased randomized trials. ...
... • via the Premarket Approval (PMA) process [6]. This is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of all medical devices that involve a high level of risk. ...
Conference Paper
Full-text available
Medical robotic systems are successfully employed in various surgical specialties today. Yet, a substantial number of remarkable systems that have been developed and piloted, have failed to reach commercialization and thus adoption in clinical practice. This is partly due to the strict regulatory requirements, which typically occupy a significant amount of the development time while incurring additional costs. Pertinent to regulatory approvals is the field of Human Factors, which plays a central role in the design of safe and efficient medical devices. This study briefly introduces the FDA regulatory approval process, discusses the role of human factors in the design process and highlights specific robotic systems that have obtained approval for clinical use. The purpose is to show the status of robotic technologies in relation to the current clinical practice.
... Entes reguladores a nivel mundial[13] Tabla 3. Protocolos de evaluación de desempeño de tecnología médica[8]-[10] Establece máximos y mínimos basado en a OIML R16-1.ESHAñadió ciertos requisitos específicos para determinar la fiabilidad de los esfigmomanómetros en un grupo de pacientes y que deben cumplirse para poder recomendar dichos dispositivos La Unión Europea EN 1060-Part IV. Exige la obtención del sello de calidad, un reconocido galardón que cuenta con la homologación de la Liga Alemana contra la Hipertensión. ...
Article
primum non nocere "lo primero es no hacer daño" es uno de los pilares fundamentales de la atención en salud; por lo que disminuir los eventos adversos asociados al uso de equipos y dispositivos médicos es uno de los retos más importantes para las entidades prestadoras de servicios de salud. Lograr esto implica coordinar muchos procesos relacionados entre sí, como son los mantenimientos preventivos, correctivos, control metrológico y validación de tecnología entre otros; esto se dificulta mas cuando el hecho de dar cumplimiento a normas que exigen la realización de pruebas de desempeño, se une con la carencia de laboratorios o entidades que realicen este tipo de pruebas a equipos médicos en Colombia. Adicional a esto, en el país se ha incrementado el número de empresas que desarrollan tecnología médica y que para obtener los permisos necesarios para comercialización se encuentran con la falencia de laboratorios y procesos adecuados para certificar dicha tecnología. Para demostrar el funcionamiento adecuado de la tecnología médica se requieren laboratorios que tengan la competencia técnica y capacidad operativa para suplir esta necesidad, y las empresas de desarrollo requieren además, contar con un laboratorio certificado o acreditado para tal fin.En Colombia, las universidades cuentan con la infraestructura y dotación para realizar estas evaluaciones, pero no con los métodos o procesos para ser laboratorios de pruebas.Este trabajo plantea una opción, a través de la creación de un modelo de gestión para el laboratorio del Grupo de Investigación en Bioinstrumentación e Ingeniería Clínica GIBIC del programa de Bioingeniería de la Universidad de Antioquia, en el cual se cuente con los procesos, protocolos, tecnología y personal adecuado para garantizar la realización adecuada de pruebas de desempeño, la metodología incluyó desde la creación del organigrama y la definición de normatividad a cumplir obteniendo finalmente el diseño y validación de protocolos de prueba para diferentes tecnologías.
... 22 Therefore, evaluation of the safety of new devices, and particularly the different parameters that are available in the specific device being tested, is essential and is considered a vital part of FDA regulations. 23 In accordance with the increasing number of medical devices being developed, information on preclinical animal trials with such devices is also growing. [24][25][26][27][28] Specifically for fractional RF devices, it is important to evaluate the consistency and lack of fractional RF effects in the tissue adjacent to the application site, and the lack of any inflammatory reaction at the surrounding tissue. ...
Article
Information on the safety of energy-based dermatological surgical devices in domestic pigs, and fractional radiofrequency (RF) devices in particular, is very limited. The aim of this study was to evaluate in a GLP-compliant study in domestic pigs the local reaction and performance of a novel fractional RF device. Five female domestic pigs were subjected to fractional RF pulses, using different energy and pulse durations and depth of penetration of the pulses. The animals were evaluated clinically and histologically at different time points (days 0, 1, 3, 7, and 14) postenergy exposure. There were no microscopic or macroscopic local adverse effects in any tested power settings, and there was time-related progressive healing, reaching complete macroscopic and microscopic healing by 7 days postapplication. As expected, there was power-related progressive increase in the incidence of ablation (destruction of skin tissue by vaporization) and coagulative necrosis of the dermis from low to high power setting. This comprehensive study, using multiple power settings (both ablative and coagulative) and several time points, will be of benefit for future studies evaluating new fractional RF devices.
... Clearly, this will drastically change the medical device development scenario in the EU, as compared to the US, where 510 (k) filings facilitate regulatory clearance based upon substantial similarity with the previously approved medical devices (i.e. predicate device) [103]. Here in the EU, the implications of new MDR policy is yet to be seen, but it is safe to say that more often than before, a clinical trial will be required [104,105] In the near future, three main focus areas of development will include: i) Safer power sources; ii) non-invasive microsampling 3D printed high temperature resin + cellulose acetate size-0 enteric coated capsule containing helical channels Sampling of the GI tract contents and microbiome using osmotic pressure was tested in vitro and in vivo in pigs and primates Biocompatible [94] technologies; and iii) imaging modalities in vivo. ...
Article
Orally ingestible medical devices provide significant advancement for diagnosis and treatment of gastrointestinal (GI) tract-related conditions. From micro- to macroscale devices, with designs ranging from very simple to complex, these medical devices can be used for site-directed drug delivery in the GI tract, real-time imaging and sensing of gut biomarkers. Equipped with uni-direction release, or self-propulsion, or origami design, these microdevices are breaking the barriers associated with drug delivery, including biologics, across the GI tract. Further, on-board microelectronics allow imaging and sensing of gut tissue and biomarkers, providing a more comprehensive understanding of underlying pathophysiological conditions. In this paper, we provide an overview of recent advances in orally ingestible medical devices towards drug delivery, imaging, sensing and microsurgery. Challenges associated with gut microenvironment, together with various activation/actuation modalities of medical devices towards micromanipulation of the gut are discussed. We have critically examined the relationship between materials–device design–pharmacological responses with respect to existing regulatory guidelines and provide a clear blueprint for the future.
Thesis
With the existence of cutting-edge technology and research and development present in the world today, there is elevated expectations that defective product could be minimized, if not eliminated. This has dramatically led to the inevitability of product recall in this era. The motivation of this research stems from an increase in software failure recalls throughout the years, with in-vitro diagnostics and imaging as the two main categories of software medical device recall, which results in faults going undetected before getting in contact with the end-user, increase in the number of injuries and death and increase in financial losses accrued by the recalling firm. In this study, a framework comprising of text mining, latent semantic analysis and classification algorithms that predict the failure type experienced by the above-mentioned devices via the application of machine learning algorithms is developed by using the Food and Drug Administration Weekly Enforcement Report dataset. Four popular machine learning algorithms, the percentage-split method, and seven classifiers performance evaluation metrics such as classification accuracy, specificity, sensitivity, Matthews’ correlation coefficient and execution time are used. The framework can easily identify and classify devices with control flow faults from those with integration fault. Furthermore, receiver optimistic curves and area under the curves for each classifier is computed. The performance of the proposed system has been validated on full features, with an 80% on the training set, and the remaining 20% on the test set. The framework presented in this paper would act as a machine-learning-based decision support system that will assist medical device manufacturers to detect medical devices with faults efficiently.
Prescription Drug User Fee Act; public meeting: docket No. FDA-2010-N00128
Federal Register. Prescription Drug User Fee Act; public meeting: docket No. FDA-2010-N00128: March 2010. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi ?dbname=2010_register&docid=fr16mr10-68.pdf. Accessed August 18, 2010.
Medical device user fee rates for fiscal year 2010: Docket No. FDA-2009-N-0338
  • Federal Register
Federal Register. Medical device user fee rates for fiscal year 2010: Docket No. FDA-2009-N-0338: August 2009. http://edocket.access.gpo.gov/2009/E9-18456 .htm. Accessed June 21, 2010.
Understanding the premarket notification 510(k) process: FDA's 510(k) working group presentation to the Institute of Medicine
  • D-B Tillman
Tillman D-B. Understanding the premarket notification 510(k) process: FDA's 510(k) working group presentation to the Institute of Medicine: March 2010. http://www .iom.edu/~/media/Files/Activity%20Files/PublicHealth/510kProcess/2010-MAR-01
FDA's 510(k) workshop: issues related to postmarket surveillance and new information about marketed devices
  • H S Rosecrans
Rosecrans HS. FDA's 510(k) workshop: issues related to postmarket surveillance and new information about marketed devices: February 2010. http://www .fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences /UCM201345.pdf. Accessed March 2, 2010.
Medical devices: are current regulations doing enough for patients? testimony before the Subcommittee on Health
  • W H Maisel
Maisel WH. Medical devices: are current regulations doing enough for patients? testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives: June 2009. http: //energycommerce.house.gov/index.php?option=com_content &view=article&id=1677. Accessed August 31, 2009.
Medical Device User Fee Act; public meeting: Docket No. FDA2010-N00389
  • Federal Register
Federal Register. Medical Device User Fee Act; public meeting: Docket No. FDA2010-N00389: August 2010. http://edocket.access.gpo.gov/2010/2010-19843 .htm. Accessed August 13, 2010.
Batelle says 510(k) recalls since '98 are at less than 1%
  • M Mccarty
McCarty M. Batelle says 510(k) recalls since '98 are at less than 1%. http://www .medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher ?next=bioWorldHeadlines_article&forceid=72862. Accessed November 9, 2010.
AdvaMed statement on FDA public meeting (press release)
  • Advamed
AdvaMed. AdvaMed statement on FDA public meeting (press release). October 2010. http://www.advamed.org/MemberPortal/About/NewsRoom/NewsReleases /PR-FDA510K-10810.htr. Accessed November 9, 2010.
Article
Medical devices are common in clinical practice and have important effects on morbidity and mortality, yet there has not been a systematic examination of evidence used by the US Food and Drug Administration (FDA) for device approval. To study premarket approval (PMA)--the most stringent FDA review process--of cardiovascular devices and to characterize the type and strength of evidence on which it is based. Data Sources and Systematic review of 78 summaries of safety and effectiveness data for 78 PMAs for high risk cardiovascular devices that received PMA between January 2000 and December 2007 [corrected]. Examination of the methodological characteristics considered essential to minimize confounding and bias, as well as the primary end points of the 123 studies supporting the PMAs. Thirty-three of 123 studies (27%) used to support recent FDA approval of cardiovascular devices were randomized and 17 of 123 (14%) were blinded. Fifty-one of 78 PMAs (65%) were based on a single study. One hundred eleven of 213 primary end points (52%) were compared with controls and 34 of 111 controls (31%) were retrospective. One hundred eighty-seven of 213 primary end points (88%) were surrogate measures and 122 of 157 (78%) had a discrepancy between the number of patients enrolled in the study and the number analyzed. Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias.