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United States Government Accountability Office: 
GAO: 

Testimony: 

Before the Special Committee on Aging, U.S. Senate: 

For Release on Delivery: 
Expected at 2:00 p.m. EDT:
Wednesday, April 13, 2011: 

Medical Devices: 

FDA's Premarket Review and Postmarket Safety Efforts: 

Statement of Marcia Crosse:
Director, Health Care: 

GAO-11-556T: 

GAO Highlights: 

Highlights of GAO-11-556T, a testimony before the Special Committee on 
Aging, U.S. Senate. 

Why GAO Did This Study: 

The Food and Drug Administration (FDA) is responsible for overseeing 
medical devices sold in the United States. In general, new devices are 
subject to FDA review via either the 510(k) premarket notification 
process, which determines if a device is substantially equivalent to 
another legally marketed device, or the more stringent premarket 
approval (PMA) process, which requires the manufacturer to supply 
evidence providing reasonable assurance that the device is safe and 
effective. FDA also has broad responsibilities for postmarket 
surveillance of devices, including oversight of recalls. A recall 
involves the correction or removal of a product from the market and is 
an important remedial action that can mitigate the risks associated 
with a defective or unsafe medical device. In recent years, GAO has 
identified a wide variety of concerns related to FDA’s ability to 
fulfill its mission of protecting the public health and added FDA’s 
oversight of medical products, including devices, to its list of high-
risk areas. 

This statement provides an update on FDA’s actions in response to a 
recommendation made in GAO’s report, Medical Devices: FDA Should Take 
Steps to Ensure That High-Risk Device Types Are Approved through the 
Most Stringent Premarket Review Process (GAO-09-190, January 15, 
2009). It also contains preliminary information on FDA’s oversight of 
medical device recalls. Because of the preliminary nature of this 
work, GAO is not making recommendations at this time. 

What GAO Found: 

FDA has begun to take steps to address GAO’s 2009 recommendation about 
high-risk devices that are allowed to enter the U.S. market through 
the less stringent 510(k) process, but progress has been limited. High-
risk devices include those which are implantable or life sustaining. 
In 2009, GAO recommended that FDA expeditiously take steps to issue 
regulations for the device types classified as high risk that are 
currently allowed to enter the market via the 510(k) process. Since 
then, FDA has set strategic goals to address these device types, but 
has issued a final rule regarding the classification of only one 
device type. As of April 1, 2011, FDA’s action on the 26 remaining 
types of high-risk devices was incomplete. Thus, these types of 
devices—such as automated external defibrillators and implantable hip 
joints—can still enter the U.S. market through the less stringent 
510(k) process. GAO found that, since its report was issued in January 
2009, FDA has cleared at least 67 510(k) submissions that fall within 
these high-risk device types. FDA has taken some additional steps to 
enhance premarket device safety since GAO’s 2009 report was issued-—
for example, it commissioned the Institute of Medicine to conduct an 
independent review of the premarket review process—-but it is too 
early to tell whether any forthcoming changes will enhance public 
health. 

GAO’s preliminary analysis shows that, from 2005 through 2009, firms 
initiated 3,510 voluntary medical device recalls, an average of just 
over 700 per year. Although FDA maintains extensive information on 
each recall, it has not been routinely analyzing recall data that 
would allow it to explain trends in recalls over time, thus missing an 
opportunity to proactively identify and address the risks presented by 
unsafe devices. GAO’s preliminary work also identified several gaps in 
the medical device recall process that limited recalling firms’ and 
FDA’s abilities to ensure that the highest-risk recalls were being 
implemented in an effective and timely manner. GAO found that firms 
frequently were unable to correct or remove all devices subject to the 
highest-risk recalls. GAO’s preliminary findings indicate that FDA 
lacks clear guidance for overseeing recalls which has led to 
inconsistencies in FDA’s assessments of whether individual recalls 
were implemented effectively. Consequently, FDA officials examining 
similar situations sometimes reached opposite conclusions regarding 
whether recalls were effective. In addition, FDA had not established 
thresholds for assessing whether firms effectively completed recalls 
by correcting or removing a sufficient number of recalled devices. 
Further, GAO determined that FDA’s decisions to terminate completed 
recalls—-that is assess whether firms had taken sufficient actions to 
prevent a reoccurrence of the problems that led to the recalls-—were 
frequently not made within its prescribed time frames. Finally, GAO 
found that FDA did not document its justification for terminating 
recalls. Taken together, GAO’s preliminary work suggests that the 
combined effect of these gaps may increase the risk that unsafe 
medical devices could remain on the market. 

View [hyperlink, http://www.gao.gov/products/GAO-11-556T] or key 
components. For more information, contact Marcia Crosse at (202) 512-
7114 or crossem@gao.gov. 

[End of section] 

Chairman Kohl, Ranking Member Corker, and Members of the Committee: 

I am pleased to be here today as you examine issues related to medical 
device safety. Americans depend on the Food and Drug Administration 
(FDA) to ensure that medical products sold in the United States are 
safe and effective. FDA's responsibilities begin before a new device 
is brought to market and continue after its clearance or approval. 
Among other things, FDA reviews thousands of submissions for new 
devices filed each year to decide whether they should be allowed to be 
marketed in the United States. FDA is also responsible for oversight 
of thousands of devices already on the market. 

In general, unless exempt by regulation, new devices are subject to 
FDA premarket review via either the 510(k) premarket notification 
process, to determine whether a new device is substantially equivalent 
to another legally marketed device, or the more stringent premarket 
approval (PMA) process, which requires the manufacturer to supply 
evidence providing reasonable assurance that the device is safe and 
effective. In addition to its premarket duties, FDA also has broad 
responsibilities for postmarket surveillance of thousands of devices 
already on the market, including overseeing recalls. A recall involves 
the correction or removal of a product from the market and is an 
important remedial action that can mitigate the risk of serious health 
consequences associated with a defective or unsafe medical device. 

Over the last several years we have identified a wide variety of 
concerns related to FDA's ability to fulfill its mission of protecting 
the public health, including weaknesses in FDA's premarket review and 
postmarket surveillance activities related to medical devices. 
[Footnote 1] As a result, FDA's oversight of medical products was 
added to our list of high-risk areas in 2009 and was also included on 
our 2011 update of this list.[Footnote 2] 

In January 2009, we reported on concerns with FDA's premarket review 
of medical devices.[Footnote 3] Specifically, we found that a 
significant number of high-risk devices--including device types that 
FDA has identified as implantable; life sustaining; or posing a 
significant risk to the health, safety, or welfare of a patient--were 
cleared for the U.S. market through FDA's less stringent 510(k) review 
process. We recommended that FDA expeditiously take steps to ensure 
that high-risk device types are approved through the agency's more 
rigorous PMA review process. More recently, we have turned our 
attention to postmarket surveillance and are currently conducting work 
assessing FDA's oversight of medical device recalls. 

My remarks today will focus on concerns that we previously raised 
regarding the 510(k) process and will include an update on the steps 
FDA has taken in response to the recommendation contained in our 
January 2009 report. I will also share our preliminary findings from 
our ongoing work related to FDA's oversight of the medical device 
recall process. 

For this statement, we interviewed FDA officials and reviewed 
pertinent statutes, regulations, Federal Register notices, and other 
documents. To determine the steps FDA has taken in response to our 
2009 recommendation, we analyzed information from FDA databases 
[Footnote 4] and obtained information on actions taken from FDA's Web 
site and FDA officials. For our ongoing work on medical device 
recalls, we obtained information from FDA's Recall Enterprise System 
on all voluntary recalls initiated and reported to FDA from January 1, 
2005, through December 31, 2009.[Footnote 5] We then used this 
information to determine, among other things, the number of recalls 
initiated per year; the number of recalls by recall risk levels; and 
status of the recalls. In addition, we examined FDA's oversight of 53, 
or 40 percent, of all high-risk recalls that were initiated from 
January 1, 2005, through December 31, 2009. For each of these 53 
recalls, we obtained and reviewed the case files which documented 
firms' and FDA's actions. We reviewed key documents such as 
information from the firms on the causes of the recalls, the firms' 
actions to prevent reoccurrence of similar problems, the recall 
notifications firms sent out to customers, and FDA's correspondence 
with firms. As part of our review, we reviewed whether firms and FDA 
followed FDA's procedures for implementing and overseeing the recalls. 
We determined that the data we used for our report were sufficiently 
reliable for our purposes. We received technical comments on a draft 
of this statement from FDA, which we incorporated as appropriate. 

We conducted our work related to FDA's premarket review of medical 
devices and our update of that work in accordance with generally 
accepted government auditing standards.[Footnote 6] Those standards 
require that we plan and perform the audit to obtain sufficient, 
appropriate evidence to provide a reasonable basis for our findings 
and conclusions based on our audit objectives. We believe that the 
evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. We are also conducting our 
work on FDA's oversight of medical device recalls in accordance with 
generally accepted government auditing standards.[Footnote 7] Because 
of the preliminary nature of this work, we are not making 
recommendations on FDA's recall process at this time. 

Background: 

FDA classifies each device type into one of three classes based on the 
level of risk it poses and the controls necessary to reasonably ensure 
its safety and effectiveness.[Footnote 8] Examples of types of devices 
in each class include the following: 

* class I: tongue depressors, elastic bandages, reading glasses, and 
forceps; 

* class II: electrocardiographs, powered bone drills, and mercury 
thermometers; and: 

* class III: pacemakers and replacement heart valves. 

Premarket Review of Medical Devices: 

Before medical devices may be legally marketed in the United States, 
they are generally subject to one of two types of FDA premarket 
review, unless exempt by FDA regulations.[Footnote 9] These reviews 
are: 

* Premarket approval or PMA process: The manufacturer must submit 
evidence, typically including clinical data, providing reasonable 
assurance that the new device is safe and effective. The PMA process 
is the most stringent type of premarket review. A successful 
submission results in FDA's approval to market the device. 

* Premarket notification or 510(k) process: Premarket notification is 
commonly called "510(k)" in reference to section 510(k) of the Federal 
Food, Drug, and Cosmetic Act, where the notification requirement is 
listed. The manufacturer must demonstrate to FDA that the new device 
is substantially equivalent to a device already legally on the market 
that does not require a PMA.[Footnote 10] For most 510(k) submissions, 
clinical data are not required and substantial equivalence will 
normally be determined based on comparative descriptions of intended 
device uses and technological characteristics, and may include 
performance data. A successful submission results in FDA's clearance 
to market the device. 

In general, class I and II device types subject to premarket review 
are required to obtain FDA clearance through the 510(k) process, and 
class III device types are required to obtain FDA approval through the 
more rigorous PMA process. With the enactment of the Medical Device 
Amendments of 1976, Congress imposed requirements under which all 
class III devices would be approved through the PMA process before 
being marketed in the United States.[Footnote 11] However, certain 
types of class III devices that were in commercial distribution in the 
United States before May 28, 1976,[Footnote 12] (called preamendment 
device types) and those determined to be substantially equivalent to 
them may be cleared through the less stringent 510(k) process until 
FDA publishes regulations requiring them to go through the PMA process 
or reclassifies them into a lower class.[Footnote 13] Between 1976 and 
1990, FDA issued regulations requiring some class III device types to 
go through the PMA process, but many class III device types continued 
to be reviewed through the 510(k) process. The Safe Medical Devices 
Act of 1990 required FDA (1) to re-examine the preamendment class III 
device types for which PMAs were not yet required to determine if they 
should be reclassified to class I or II or remain in class III and (2) 
to establish a schedule to promulgate regulations requiring those 
preamendment device types that remain in class III to obtain FDA 
approval through the PMA process.[Footnote 14] Accordingly, all class 
III devices are eventually to be reviewed through the PMA process. 

In our January 2009 report, we found that although Congress envisioned 
that all class III devices would be approved through the more 
stringent PMA process, the agency's actions to make this the case were 
incomplete. We found that in fiscal years 2003 through 2007, FDA 
continued to clear submissions for class III devices through the less 
stringent 510(k) process--clearing 228 over the 5-year period. We 
recommended that FDA expeditiously take steps to issue regulations for 
each class III device type allowed to enter the market through the 
510(k) process, including to (1) reclassify each device type into 
class I or class II, or requiring it to remain in class III, and (2) 
for those device types remaining in class III, require approval for 
marketing through the PMA process. FDA agreed with our recommendation 
when we issued our report, but did not specify time frames in which it 
would take action. 

Postmarket Oversight of Voluntary Medical Device Recalls: 

Overseeing recalls is an important element of FDA's postmarket 
responsibilities. FDA defines a recall as a firm's removal or 
correction of a marketed product that FDA (1) considers to be in 
violation of the laws it administers, and (2) against which the agency 
would initiate legal actions.[Footnote 15] Nearly all medical device 
recalls are voluntarily initiated by a recalling firm, usually the 
manufacturer of the device. To initiate a voluntary recall, a firm 
notifies those who have received, purchased, or used the device. The 
firm may be asked to provide FDA with information such as the reason 
for the correction or removal of the device, an assessment of the 
health hazard associated with the device, and the volume of product in 
distribution and proposed strategy for conducting the recall.[Footnote 
16] The strategy should contain details on the firm's plan for 
ensuring that its customers and device users correct or remove the 
device according to the firm's instructions. FDA's role is generally 
to oversee a firm's management of a recall. As part of its oversight, 
FDA reviews and recommends changes to the recall strategy and assigns 
one of three recall classifications--class I, II, or III--to indicate 
the relative degree of health hazard posed by the product being 
recalled. For a class I recall, FDA has determined that there is a 
reasonable probability that use of, or exposure to, the product could 
cause serious adverse health consequences or death. Class II recalls 
are those for which FDA has determined that the use of, or exposure 
to, the product could cause temporary or medically reversible adverse 
health consequences or that the probability of serious adverse health 
consequences is remote. For class III recalls, FDA has determined that 
use of, or exposure to, a device is not likely to cause adverse health 
consequences. FDA advises the recalling firm of the assigned recall 
classification; and posts information about the recall in its weekly 
enforcement report. 

It is important to note that FDA's device and recall classification 
schemes carry opposite designations. The potential degree of health 
risk associated with device classes is designated from class III 
(high) to class I (low), while the potential risk associated with 
recall classes is designated from class I (high) to class III (low). 

FDA also monitors the progress of a recall and verifies whether the 
recalling firm has effectively implemented the recall strategy. FDA 
requests that a recalling firm periodically provide the monitoring 
district with status reports that provide updates on the progress of 
recalls. FDA district staff also conduct audit checks to confirm that 
the recalling firm has properly corrected or removed devices from the 
market, in accordance with the recall strategy. Once the firm believes 
it has completed the recall--that is, done everything as outlined in 
the recall strategy--it should submit a recall termination request to 
the monitoring district office. As part of the termination decision, 
FDA should assess whether the firm has taken sufficient corrective 
actions to prevent a reoccurrence of the problem that led to the 
recall. For class I recalls, FDA district staff review a firm's 
request, and if they agree, send a recall termination request to 
headquarters. For class II and III recalls, FDA district staff make 
the final termination decision. According to FDA's procedures, FDA 
should terminate a recall within 3 months after the firm completes the 
recall. 

FDA Has Taken Some Actions in Response to Our Recommendation to 
Strengthen the Premarket Review Process, but Concerns About the 510(k) 
Process Remain: 

FDA has begun to take steps to address our 2009 recommendation about 
class III devices that are still allowed to enter the U.S. market 
through the less stringent 510(k) process, but progress has been 
limited. Concerns persist about the effectiveness of the 510(k) 
process in general, including its ability to provide adequate 
assurance that devices are safe and effective. In 2009, we recommended 
that FDA expeditiously take steps to address class III device types 
allowed to enter the market via the 510(k) process by issuing 
regulations requiring submission of PMAs or reclassifying them to a 
lower class. Since our report was issued, the agency has set strategic 
goals to address this matter, but has issued a final rule regarding 
the classification of only one device type.[Footnote 17] As of April 
1, 2011, 26 additional class III device types could still enter the 
U.S. market through the less stringent 510(k) process. 

FDA has been taking steps to address the 26 class III device types-- 
including automated external defibrillators and implantable hip 
joints--that can still enter the U.S. market through the 510(k) 
process. Specifically, FDA is following a 5-step process to require 
PMAs or to reclassify them to a lower device class. As shown in table 
1, as of April 1, 2011, FDA was at step 2--assessing the risk and 
benefits--for 21 device types.[Footnote 18] FDA was at step 4--
receiving and reviewing comments provided on proposed rules--for 5 
other device types, but had not yet issued final rules requiring PMAs 
or reclassifying any of them.[Footnote 19] 

Table 1: Status of FDA Action for 26 Class III Device Types that Can 
Be Cleared through the 510(k) Process, as of April 1, 2011: 

Step in FDA process: Step 1; 
FDA collects existing information, which includes publishing a Federal 
Register notice to solicit information, and may include holding an FDA 
advisory panel meeting; 
Number of device types at this step in the process: 0. 

Step in FDA process: Step 2; 
FDA assesses the risks and benefits; 
Number of device types at this step in the process: 21. 

Step in FDA process: Step 3; 
FDA proposes classification into class I, II, or III, which is 
announced as a proposed rule in a Federal Register notice; 
Number of device types at this step in the process: 0. 

Step in FDA process: Step 4; 
FDA receives and reviews comments provided; 
Number of device types at this step in the process: 5. 

Step in FDA process: Step 5; 
FDA finalizes classification into class I, II, or III, which is 
announced as a final rule in a Federal Register notice[A]; 
Number of device types at this step in the process: 0. 

Source: GAO analysis of FDA information. 

Note: This table presents the FDA 5-step process and status from the 
FDA Web site [hyperlink, 
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm2403
18.htm], accessed April 1, 2011. 

[A] For device types retained in class III, FDA will call for PMA 
applications and sponsors of devices previously cleared through the 
510(k) process will need to submit PMA applications in order to 
continue to market their devices (with a grace period to permit 
possible transition to obtaining PMA approval). 

[End of table] 

While FDA has taken essential initial steps toward implementing our 
recommendation, until the agency issues final regulations either 
reclassifying or requiring PMAs for class III device types that 
currently can be cleared through the less stringent 510(k) process, 
its actions remain incomplete. Thus, these 26 device types can still 
enter the U.S. market through the less stringent premarket review 
process. Since we issued our report in January 2009, FDA cleared at 
least 67 individual submissions that fall within 12 of these class III 
device types through the 510(k) process.[Footnote 20] 

Subsequent to the issuance of our 2009 report and in response to 
numerous concerns over the effectiveness of the 510(k) process, 
including its ability to provide adequate assurance that devices are 
safe and effective, FDA announced it would take additional actions to 
enhance premarket device safety. In 2009, FDA reported that it would 
conduct its own comprehensive internal assessment of the premarket 
medical device approval process and commissioned the Institute of 
Medicine to conduct an independent review to assess whether the 510(k) 
process sufficiently protects patients and promotes public health. The 
Institute of Medicine is expected to issue its report in mid-2011. 

Shortcomings in FDA's Oversight of the Highest-Risk Medical Device 
Recalls Increase the Risk That Unsafe Devices Continue to Be Used: 

Our preliminary findings suggest that shortcomings in FDA's oversight 
of the medical device recall process may limit the agency's ability to 
ensure that the highest-risk recalls are being implemented in an 
effective and timely manner. These shortcomings span the entire range 
of the agency's oversight activities--from the lack of a broad-based 
program to systematically assess trends in recalls, to inconsistencies 
in the way FDA ensures the effective completion of individual recalls. 

FDA Has Not Routinely Used Recall Data to Aid Its Oversight of the 
Recall Process: 

Although FDA's recall data system contains numerous data elements that 
would allow for analyses of recall data, our preliminary findings 
suggest that FDA is not using this system to effectively monitor and 
manage its recall program. This system contains information on, for 
example, the status of each recall (e.g., ongoing or terminated); the 
reason for the recall; the specific device being recalled; the recall 
classification level assigned based on FDA's assessment of risk; the 
dates the recalls were initiated, classified, and terminated; and the 
medical specialty--area of use--for each device subject to recall 
(e.g., cardiovascular or orthopedic). However, FDA has not routinely 
used these recall data as a surveillance tool or for examining broad 
trends of medical device recalls.[Footnote 21] Instead of using this 
information to conduct systemic analyses of the recall program, which 
would be consistent with the agency's strategic goal of improving the 
quality and safety of manufactured products in the supply chain, FDA 
has primarily been using data from its recall system for processing 
individual recalls. 

Our preliminary analysis showed that between January 1, 2005, and 
December 31, 2009, firms initiated 3,510 device recalls. Only a small 
percentage of these recalls--about 4 percent--were classified by FDA 
as class I recalls--those that pose a reasonable probability that the 
use of, or exposure to, these products will cause serious adverse 
health consequences or death. The vast majority--nearly 83 percent--
were classified by FDA as class II recalls, meaning use of, or 
exposure to, these devices may cause temporary or medically reversible 
adverse health consequences or that the probability of serious adverse 
health consequences is remote; and about 14 percent were classified as 
class III recalls, which pose the lowest risk. 

Based on our preliminary analysis, we provided key summaries to FDA 
officials and asked them to comment on trends that we observed. 
Officials indicated that they have not fully analyzed these data and 
could not explain trends without extensive research of individual case 
files. For example, they could not explain why the majority of recalls 
are class II, why class I recalls more than doubled between 2008 and 
2009, or why many recalls had been ongoing for 5 years. Officials also 
could not provide definitive answers when we asked them to comment on 
other related topics, such as: 

* trends in the number of recalls over time; 

* variation in the numbers of recalls by recall classification levels; 

* types of devices and medical specialties of devices accounting for 
most recalls; and: 

* length of time needed to complete or terminate recalls. 

Although FDA has not been routinely analyzing recall data to assess 
the effectiveness of the recall process, officials indicated that they 
have used these data to support compliance and subsequent enforcement 
actions. For example, officials indicated that they use recall data to 
help identify which firms the agency should inspect for assessing 
compliance with laws and regulations. 

FDA Inconsistently Assessed the Effectiveness of Recalls: 

Our preliminary analysis revealed inconsistencies in FDA's assessments 
of the effectiveness of recalls. A key tool to making these 
assessments are FDA's "audit checks" in which investigators from FDA's 
district offices contact a percentage of customers or device users 
affected by the recall to determine whether they received the recall 
notice and followed the recalling firm's instructions for removing or 
correcting the device. However, we identified numerous inconsistencies 
in the way FDA's investigators implemented these audit checks, 
resulting in conflicting determinations about whether recalls were 
effectively conducted. 

Our analysis of 2,196 audit check forms associated with the class I 
recalls we reviewed found a variety of inconsistencies in how the 
audit checks were implemented and documented for nearly 90 percent of 
these recalls.[Footnote 22] For each of these recalls we found 
inconsistencies in how different investigators determined whether a 
recall was effective or ineffective when conducting their audit checks 
of recalls. We also identified inconsistencies in the level of detail 
provided in the audit check report and the level of effort undertaken 
by different investigators. These recalls covered a wide range of 
devices, including implantable pumps and automated external 
defibrillators. For example, when conducting audit checks, some 
investigators concluded that recalls were effective, despite noting 
problems (such as device users not following the firm's instructions), 
while other investigators concluded under similar circumstances that 
recalls were ineffective. In other recalls, some investigators noted 
actions they took when they discovered problems, such as providing the 
device users with a copy of the recall notice or instructing them on 
actions to take in order to implement a recall. In contrast, other 
investigators did not indicate whether they made any attempt to help 
the user implement the recall. 

FDA officials at both headquarters and the district offices we 
contacted acknowledged that there are no detailed instructions or 
requirements for conducting audit checks and that there can be 
inconsistencies in the process. They also agreed that this may be an 
area where enhanced guidance is needed. 

FDA Lacks Specific Criteria to Determine Whether Firms Have Taken 
Adequate Steps to Correct or Remove Recalled Devices: 

One of the gaps in FDA's recall process suggested by our preliminary 
work is that FDA lacks specific criteria for making decisions about 
whether recalling firms have effectively completed their recalls by 
taking adequate steps to correct or remove recalled devices. Our 
preliminary review of FDA's recall procedures found that the 
procedures do not contain any specific criteria or general guidelines 
governing the extent to which firms should be correcting or removing 
various types of devices--such as a benchmark recall rate--before a 
recall should be considered completed. FDA officials indicated they 
consider a recall complete when a firm has completed actions outlined 
in its recall strategy. In particular, they evaluate whether firms 
completed their assigned level of effectiveness checks, and have 
corrected or removed recalled devices in "an acceptable manner." 
However, FDA officials said that they do not have specific criteria or 
thresholds concerning the proportion of various types of devices that 
firms should be able to correct or remove. 

Our preliminary review shows that firms are not always able to correct 
or remove all unsafe medical devices from the market. Of the 53 class 
I recalls we reviewed, we found 10 were ongoing, 14 were completed-- 
meaning that FDA district office officials concluded that the firm had 
fulfilled its responsibilities for correcting or removing the devices--
and 29 were terminated--meaning that FDA headquarters determined that 
recalling firms had taken sufficient corrective actions to prevent 
reoccurrence of the problems that led to the recalls.[Footnote 23] Of 
the 43 recalls in our sample that were either completed or terminated, 
we found that for 20, or 47 percent of these recalls, firms were able 
to correct or remove all products. However, we found that in the other 
23 recalls, or 53 percent, firms were unable to correct or remove all 
products. These recalls ranged widely, in both volume of devices 
subject to recall and the types of devices being recalled. Some 
recalls involved hundreds of thousands of disposable products, while 
others involved a small number of life-sustaining implantable devices. 
Recalling firms were often unable to correct or remove all devices. 
This was because firms either could not locate some of the customers 
or device users, or these customers or device users could not locate 
the devices subject to recall. In other cases, devices could not be 
corrected or removed because they were sold at retail outlets (such as 
glucose test strips) to individuals who may not have known about the 
recall. For example, in a recall of tracheal tubes included in certain 
pediatric medical kits, 1,400 tubes had been distributed but only 200 
were returned to the recalling firm. The firm said that the rest had 
likely been used. 

FDA's Recall Termination Process Is Compromised by Weak Procedures and 
May Result in Recalled Medical Devices Remaining on the Market: 

Our preliminary findings also suggest another gap in the recall 
process--insufficient documentation justifying FDA's termination 
decisions. Without such documentation, we were unable to assess the 
extent to which FDA's termination process appropriately evaluated 
recalling firms' corrective actions. Although FDA requests that firms 
submit corrective and preventive action plans for review and approval 
before a recall can be terminated, we found little documentation 
regarding how FDA assessed whether such plans were sufficient when it 
terminated recalls. When we asked to review documentation justifying 
the decisions for the 29 terminated recalls in our sample, FDA 
officials indicated that they do not maintain extensive documentation 
justifying the basis for their termination decisions. They told us 
that creating documentation to support concurrence with the 
termination recommendation is not part of past or current termination 
procedures. This approach is inconsistent with internal control 
standards for the federal government, which indicate "that all 
transactions and other significant events need to be clearly 
documented," and stress the importance of "the creation and 
maintenance of related records which provide evidence of execution of 
these activities as well as appropriate documentation."[Footnote 24] 

Also, we found that FDA termination decisions were frequently not made 
in a timely manner--within 3 months of the completion of the recall-- 
increasing the risk that unsafe or defective devices remained 
available for use. Of the 53 recalls in our sample, 29 were 
terminated--meaning FDA headquarters agreed with an FDA district 
office that the firm did not need to take additional actions to 
prevent reoccurrence of problems that led to the recall. For 72 
percent of the terminated recalls, FDA did not make its termination 
decision within 3 months of the recall's completion, as called for in 
FDA's regulatory procedures. Overall, termination decisions took on 
average 180 business days from the completion date, though they ranged 
from 10 days to 800 days after that date. 

We found at least one instance where FDA's failure to make a timely 
termination assessment allowed for a potentially unsafe product to be 
re-introduced into the market and used for surgical procedures. In 
this case, based on adverse event reports that screws in its spinal 
fixation system were becoming loose post-operatively, the firm decided 
to recall the device in December 2005. The firm implemented its 
recall, and removed all devices. The firm indicated that it developed 
a corrective action plan for the screw problem, and relaunched the 
device in April 2006. It then requested termination from FDA in May 
2006. FDA followed up on this request by leaving three voice mail 
messages with the firm and received no response. The agency sent out a 
request for information a year later, in May 2007. In June 2007, the 
company again indicated that the recall was complete, and requested 
termination. In September 2007, FDA conducted an inspection of the 
company's manufacturing facility, and found that while the recall was 
complete, the corrective action was not adequate. Over the course of 
the next 2 years, the firm worked with FDA to get revisions to the 
device approved, but eventually agreed to a second recall for the 
revised device. This recall was initiated in May 2009. We identified 
five reports of adverse events related to continuing problems with the 
implanted device that were filed with FDA subsequent to the firm's 
relaunch of the device in April 2006. These reports were filed from 
December 2006 through March 2007, and revealed that in all cases, 
patients required surgical intervention to correct or remove the 
device. 

While FDA's recent actions to try to improve the premarket approval 
process are positive steps--such as commissioning the Institute of 
Medicine to conduct an independent review of the process--it remains 
to be seen whether these actions will help ensure that medical devices 
marketed in the United States receive appropriate premarket review. In 
addition, gaps in FDA's postmarket surveillance shows that unsafe and 
ineffective devices may continue to be used, despite being recalled. 
The agency faces a challenging balancing act. While it is important to 
allow devices on the market to treat patients who need them, it is 
also essential that FDA take necessary steps to provide a reasonable 
assurance that those medical devices that do enter the market are safe 
and effective. Likewise, it is vital that the agency's postmarket 
safety efforts are both vigorous and timely. 

Chairman Kohl and Ranking Member Corker, this completes my prepared 
statement. I would be happy to respond to any questions you or the 
other members of the committee may have at this time. 

Contacts and Acknowledgments: 

For further information about this statement, please contact Marcia 
Crosse, at (202) 512-7114 or crossem@gao.gov. Contact points for our 
Offices of Congressional Relations and Public Affairs may be found on 
the last page of this statement. Geraldine Redican-Bigott and Kim 
Yamane, Assistant Directors; Helen Desaulniers; Cathy Hamann; Eagan 
Kemp; Julian Klazkin; David Lichtenfeld; Christina C. Serna; and 
Katherine Wunderink made key contributions to this report. 

[End of section] 

Related GAO Products: 

High Risk Series: An Update. [hyperlink, 
http://www.gao.gov/products/GAO-11-278]. February 2011. 

Food and Drug Administration: Overseas Offices Have Taken Steps to 
Help Ensure Import Safety, but More Long-Term Planning Is Needed. 
[hyperlink, http://www.gao.gov/products/GAO-10-960]. Washington, D.C.: 
September 30, 2010. 

Food and Drug Administration: Opportunities Exist to Better Address 
Management Challenges. [hyperlink, 
http://www.gao.gov/products/GAO-10-279]. Washington, D.C.: February 
19, 2010. 

Food and Drug Administration: FDA Faces Challenges Meeting Its Growing 
Medical Product Responsibilities and Should Develop Complete Estimates 
of Its Resource Needs. [hyperlink, 
http://www.gao.gov/products/GAO-09-581]. Washington, D.C.: June 19, 
2009. 

Medical Devices: Shortcomings in FDA's Premarket Review, Postmarket 
Surveillance, and Inspections of Device Manufacturing Establishments. 
[hyperlink, http://www.gao.gov/products/GAO-09-370T]. Washington, 
D.C.: June 18, 2009. 

Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device 
Types Are Approved through the Most Stringent Premarket Review 
Process. [hyperlink, http://www.gao.gov/products/GAO-09-190]. 
Washington, D.C.: January 15, 2009. 

High-Risk Series: An Update. [hyperlink, 
http://www.gao.gov/products/GAO-09-271]. Washington, D.C.: January 
2009. 

Health-Care-Associated Infections in Hospitals: Number Associated with 
Medical Devices Unknown, but Experts Report Provider Practices as a 
Significant Factor. [hyperlink, 
http://www.gao.gov/products/GAO-08-1091R]. Washington, D.C.: September 
26, 2008. 

Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, 
and Available Information Does Not Indicate That Use Presents an 
Elevated Health Risk. [hyperlink, 
http://www.gao.gov/products/GAO-08-147]. Washington, D.C.: January 31, 
2008. 

Medical Devices: Challenges for FDA in Conducting Manufacturer 
Inspections. [hyperlink, http://www.gao.gov/products/GAO-08-428T]. 
Washington, D.C.: January 29, 2008. 

Food and Drug Administration: Methodologies for Identifying and 
Allocating Costs of Reviewing Medical Device Applications Are 
Consistent with Federal Cost Accounting Standards, and Staffing Levels 
for Reviews Have Generally Increased in Recent Years. [hyperlink, 
http://www.gao.gov/products/GAO-07-882R]. Washington, D.C.: June 25, 
2007. 

Medical Devices: Status of FDA's Program for Inspections by Accredited 
Organizations. [hyperlink, http://www.gao.gov/products/GAO-07-157]. 
Washington, D.C.: January 5, 2007. 

[End of section] 

Footnotes: 

[1] See "Related GAO Products" at the end of this testimony. 

[2] We regularly report on government operations that we identify as 
high risk, due to their greater vulnerabilities to fraud, waste, 
abuse, mismanagement, or the need for transformation to address 
economy, efficiency, or effectiveness challenges. See GAO, High-Risk 
Series: An Update, [hyperlink, http://www.gao.gov/products/GAO-09-271] 
(Washington, D.C.: Jan. 2009); and GAO, High-Risk Series: An Update, 
[hyperlink, http://www.gao.gov/products/GAO-11-278] (Washington, D.C.: 
Feb. 2011). 

[3] See GAO, Medical Devices: FDA Should Take Steps to Ensure That 
High-Risk Device Types Are Approved through the Most Stringent 
Premarket Review Process, [hyperlink, 
http://www.gao.gov/products/GAO-09-190] (Washington, D.C.: Jan. 15, 
2009). 

[4] We analyzed information from FDA's product code classification 
database to identify class III device types that can be cleared for 
the U.S. market through the 510(k) process and analyzed information 
from that database as well as FDA's premarket notification 510(k) 
database to identify traditional and abbreviated 510(k) submissions 
for class III devices that FDA cleared for the U.S. market since we 
issued our report on January 15, 2009. Our analysis did not include 
certain types of device submissions, for example, special 510(k) 
submissions, which are requests for clearance of minor modifications 
to devices that have already been cleared through the 510(k) process. 
Because related devices can be "bundled" together in a single 
submission, one submission may include one or more devices. 

[5] While FDA has authority to order a mandatory recall, it did not 
exercise this authority during the period we reviewed. See 21 U.S.C. § 
360h(e), 21 C.F.R. pt. 810 (2010). Also, our information does not 
include devices that a firm may have voluntarily taken off the market 
for other, less serious, reasons. For example, a market withdrawal is 
a firm's correction or removal of a distributed device that involves 
no violation or a minor violation of the laws FDA administers and for 
which FDA would not initiate legal action. 21 C.F.R. § 806.2(h) (2010). 

[6] We conducted the work for our 2009 report, [hyperlink, 
http://www.gao.gov/products/GAO-09-190], from March 2008 to January 
2009. We conducted the work to update FDA actions taken in response to 
that report's recommendation from January 2011 to April 2011. 

[7] We began conducting this work in January 2010 and our work is 
ongoing. 

[8] FDA's classification of device types is codified in parts 862 
through 892 of title 21 of the Code of Federal Regulations (2010). 
Class I devices are those for which compliance with general controls, 
such as good manufacturing practices specified in FDA's quality system 
regulation, is sufficient to provide reasonable assurance of their 
safety and effectiveness. Class II devices are subject to general 
controls and may also be subject to special controls, such as 
postmarket surveillance. Class III devices are those (1) for which 
insufficient information exists to determine whether general and 
special controls are sufficient to provide reasonable assurance of the 
safety and effectiveness of the device and (2) that support or sustain 
human life or are of substantial importance in preventing impairment 
of human health, or that present a potential unreasonable risk of 
illness or injury. See 21 U.S.C. § 360c. 

[9] A small percentage of devices enter the market by other means, 
such as through the humanitarian device exemption process that allows 
market entry, without adherence to certain requirements, for devices 
benefiting patients with rare diseases or conditions. See 21 U.S.C. § 
360j(m), 21 C.F.R. pt. 814, subpart H (2010). In addition, many other 
less risky types of class I and II devices are also exempt from FDA's 
premarket review. 

[10] Substantial equivalence or substantially equivalent means that 
the device has the same intended use as another legally marketed 
device and the same technological characteristics, or that the device 
has different technological characteristics and information submitted 
to FDA demonstrates that the device is as safe and effective as the 
legally marketed device and does not raise different questions of 
safety or effectiveness. 21 U.S.C. § 360c(i)(1)(A). 

[11] See Pub. L. No. 94-295, § 2, 90 Stat. 539, 552-59 (codified at 21 
U.S.C. § 360e). 

[12] May 28, 1976, is the date of enactment of the Medical Device 
Amendments of 1976, which established the three device classes. 

[13] FDA may, by regulation, change the classification of a device 
from class III to (1) class II if it determines that special controls 
would provide reasonable assurance of the safety and effectiveness of 
the device and that general controls alone would not provide 
reasonable assurance of the safety and effectiveness of the device or 
(2) class I if FDA determines that general controls alone would 
provide reasonable assurance of the safety and effectiveness of the 
device. 21 U.S.C. § 360c(e). 

[14] Pub. L. No. 101-629, § 4(b), 104 Stat. 4511, 4515-17 (codified at 
21 U.S.C. § 360e(i)). 

[15] 21 C.F.R. § 7.3(g) (2010). A removal is the physical removal of a 
device from its point of use to some other location for repair, 
modification, adjustment, relabeling, destruction, or inspection. A 
correction may involve these actions without the physical removal of a 
device from its point of use. See 21 C.F.R. 806.2(d), (i) (2010). 

[16] The firm will contact one of FDA's district offices depending 
upon the location from which it chooses to manage the recall. This 
district will have primary responsibility for monitoring the recall. 
Each district has a recall coordinator, who, among other duties, 
processes medical device recalls and monitors the progress of the 
firm's actions. 

[17] See 74 Fed. Reg. 42773. (Aug. 25, 2009). 

[18] On April 9, 2009, FDA published a notice in the Federal Register 
requiring manufacturers of 25 of the 26 device types to submit summary 
information, including adverse safety or effectiveness information, to 
determine whether to require PMAs or to reclassify the device types. 
74 Fed. Reg. 16214. 

[19] FDA published a proposed rule on August 25, 2010, that, if 
finalized, would retain class III designation and require PMAs for 
four device types. 75 Fed. Reg. 52294. FDA published a proposed rule, 
regarding classification, for another device type on April 6, 2006. 71 
Fed. Reg. 17390. 

[20] Our analysis did not include special 510(k) submissions, which 
are requests for clearance of minor modifications to devices that have 
already been cleared through the 510(k) process. 

[21] We previously reported on the importance of establishing and 
using metrics as a management tool. See, for example, GAO, Food and 
Drug Administration: Opportunities Exist to Better Address Management 
Challenges, [hyperlink, http://www.gao.gov/products/GAO-10-279] 
(Washington, D.C.: Feb. 19, 2010). 

[22] FDA's regulatory procedures note that audit checks should be 
conducted for all class I recalls. FDA conducted audit checks for 45 
of the 53 class I recalls (85 percent) we reviewed. In six of the 
eight cases in which FDA did not conduct audit checks, the recall file 
contained written documentation explaining why audit checks were not 
conducted. 

[23] We obtained the current status of these recalls through our 
reviews of the recall files and discussions with FDA district office 
officials. These discussions took place between December 2010 and 
February 2011. 

[24] See GAO, Standards for Internal Control in the Federal 
Government, [hyperlink, 
http://www.gao.gov/products/GAO-AIMD-00-21.3.1] (Washington, D.C.: 
Nov.1999). 

[End of section] 

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