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Testimony: 

Before the Subcommittee on Health, Committee on Energy and Commerce, 
House of Representatives: 

United States Government Accountability Office: 
GAO: 

For Release on Delivery: 
Expected at 9:30 a.m. EDT:
Thursday, June 18, 2009: 

Medical Devices: 

Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and 
Inspections of Device Manufacturing Establishments: 

Statement of Marcia Crosse:
Director, Health Care: 

GAO-09-370T: 

GAO Highlights: 

Highlights of GAO-09-370T, a testimony before the Subcommittee on 
Health, Committee on Energy and Commerce, House of Representatives. 

Why GAO Did This Study: 

Americans depend on the Food and Drug Administration (FDA) to provide 
assurance that medical devices sold in the United States are safe and 
effective. FDA classifies medical device types into three classes, with 
class I including those with the lowest risk to patients (such as 
forceps) and class III including those with the greatest risk (such as 
pacemakers). FDAs responsibilities include premarket and postmarket 
oversightspanning, for example, both premarket review of devices and 
postmarket surveillance (the collection and analysis of data on 
marketed devices). These responsibilities apply to all devices marketed 
in the United States, regardless of whether they are manufactured 
domestically or overseas. In 2009, GAO added FDAs oversight of medical 
products, including devices, to its list of high-risk areas warranting 
attention by Congress and the executive branch. 

GAO was asked to testify on recent work related to FDAs 
responsibilities for medical devices, including premarket review, 
postmarket surveillance, and inspection of manufacturing 
establishments. This statement is based on a recent GAO 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) and on other GAO reports and testimonies 
related to FDA oversight. 

What GAO Found: 

GAO found that FDA does not review all class III devices through its 
most stringent premarket review process. Unless exempt by regulation, 
new devices must clear FDA premarket review through either the 510(k) 
premarket notification process, which is used to determine if a new 
device is substantially equivalent to another legally marketed device, 
or through 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 1976, Congress 
envisioned that FDA would eventually approve all class III devices 
through the more stringent PMA process, but this process remains 
incomplete. GAO found that in fiscal years 2003 through 2007, FDA 
cleared 228 submissions representing 24 types of class III devices 
through the 510(k) process. GAO recommended in its January 2009 report 
that FDA expeditiously take steps to issue regulations requiring PMAs 
for or reclassifying class III device types currently allowed to enter 
the market via the 510(k) process. In response, in April 2009, FDA 
required manufacturers to submit information on the safety and 
effectiveness of these types of devices. However, FDA did not specify a 
time frame for how quickly it will reclassify them or require PMAs for 
those device types that remain in class III. 

FDA also faces challenges in postmarket surveillance of medical 
devices. In 2008, GAO reported that the number of adverse event reports 
associated with medical devices increased substantially from 2000 to 
2006. Both GAO and FDA, however, have identified shortcomings in FDAs 
postmarket oversight. For example, in 2006 FDA reported that the agency
s ability to understand the risks related to the use of medical devices 
is limited by the fact that the volume of submitted reports exceeded 
FDAs ability to consistently enter or review the reports in a routine 
manner. In 2008, FDA officials told us that while they have a number of 
strategies to prioritize their reviews of adverse event reports, they 
still cannot review all the reports they receive. 

Finally, GAO has found that FDA has not conducted required inspections 
of manufacturing establishments, another key FDA responsibility for 
medical devices marketed in the United States. In 2008, GAO reported 
that FDA has not met a statutory requirement to inspect certain 
domestic manufacturing establishments every 2 years. Instead, FDA 
officials estimated that the agency has inspected domestic 
establishments every 3 years (for class III devices) or 5 years (for 
class II devices). There is no comparable requirement to inspect 
foreign establishments, and FDA officials estimate that they have been 
inspected every 6 years (for class III devices) or 27 years (for class 
II devices). GAO reported that FDA has taken some steps to address 
shortcomings related to inspections of foreign establishments, but GAO 
has not evaluated whether these changes will improve FDAs inspection 
program. 

Taken together, these shortcomings in both premarket and postmarket 
activities raise serious concerns about FDA's regulation of medical 
devices. 

View [hyperlink, http://www.gao.gov/products/GAO-09-370T] or key 
components. For more information, contact Marcia Crosse at (202) 512-
7114 or crossem@gao.gov. 

[End of section] 

Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today as you examine issues related to the 
regulation of medical devices. Americans depend on the Food and Drug 
Administration (FDA), an agency within the Department of Health and 
Human Services (HHS) responsible for ensuring that medical devices and 
other medical products sold in the United States are safe and 
effective.[Footnote 1] 

FDA's responsibilities for medical devices begin before a new device is 
brought to market and continue after a device's clearance or approval, 
and these responsibilities apply to devices marketed in the United 
States regardless of whether they are manufactured domestically or 
overseas. FDA reviews submissions for thousands of new devices filed 
each year to decide whether they should be allowed to be marketed in 
the United States and is also responsible for oversight of thousands of 
devices already on the market. As part of both premarket and postmarket 
oversight, the agency inspects manufacturing establishments to ensure 
they are in compliance with the good manufacturing practices specified 
in FDA's quality system regulation as well as other statutory and 
regulatory requirements. 

Recently, concerns have been expressed about FDA's ongoing ability to 
fulfill its mission of ensuring the safety and efficacy of medical 
products, including drugs, biologics, and devices. Reports issued by 
FDA's Science Board in 2007 and the Congressional Research Service in 
2008 point out that the demands on the agency have soared in recent 
years for a variety of reasons, including the complexity of new 
products submitted to FDA for premarket approval and the globalization 
of the industries that FDA regulates. The Science Board also found that 
FDA's resources had not increased in proportion to the growing demands 
placed on it, putting public health at risk. In its fiscal year 2007 
and 2008 reports, the HHS Office of Inspector General identified the 
oversight of drug and device safety as one of HHS's top management 
challenges. In January 2009, we added FDA's oversight of medical 
products, including devices, to GAO's list of high-risk areas 
warranting attention by Congress and the executive branch.[Footnote 2] 

Medical devices range from simple tools like bandages and surgical 
clamps to complicated devices like pacemakers. FDA classifies each type 
of device into one of three classes--class I, II, or III--based on the 
level of risk it poses and the controls necessary to provide reasonable 
assurance that it is safe and effective.[Footnote 3] According to FDA, 
the risk the type of device poses to the patient or the user is a major 
factor in the class it is assigned: class I includes devices with the 
lowest risk and class III includes devices with the highest risk. 
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. 

In general, unless exempt under FDA regulations,[Footnote 4] devices 
are subject to one of two types of FDA premarket review before they may 
be legally marketed in the United States.[Footnote 5] 

* Premarket approval (PMA): The manufacturer must provide 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 approval. 

* Premarket notification (510(k)): The manufacturer must demonstrate to 
FDA that the new device is substantially equivalent to a legally 
marketed device that does not require a PMA.[Footnote 6] A successful 
submission results in FDA clearance. 

My remarks today will discuss shortcomings we have identified in FDA's 
premarket review of medical devices, FDA's postmarket surveillance 
activities, and FDA's inspections of manufacturing establishments. My 
statement includes findings from our recent report on FDA's premarket 
review of medical devices.[Footnote 7] My statement also draws from 
several other GAO reports and testimonies on FDA inspections of 
domestic and foreign device manufacturing establishments and other 
aspects of FDA's oversight of devices that we have issued since 2007, 
[Footnote 8] as well as ongoing work we are conducting related to FDA. 

For this body of work, we analyzed information from FDA databases; 
[Footnote 9] interviewed FDA officials; and reviewed pertinent 
statutes, regulations, guidance, and reports. For the report on FDA's 
premarket review of devices, we examined the premarket review 
processes--the 510(k) premarket notification process or the premarket 
approval (PMA) process--FDA used in fiscal years 2003 through 2007 and 
reviewed a sample of FDA files related to submissions for new devices. 
Our analysis included traditional and abbreviated 510(k) submissions, 
original PMA submissions, and submissions for two types of supplemental 
PMAs: panel-track PMA supplements (which are supplements requesting 
approval for a significant change in design or performance, or a new 
use of a device, for which clinical data are generally necessary to 
provide reasonable assurance of safety and effectiveness) and 180-day 
PMA supplements (which are supplements requesting approval for a 
significant change in components, materials, design, specification, 
software, color additives, or labeling).[Footnote 10] 

To assess FDA's program for inspecting establishments that manufacture 
medical devices, we analyzed information from three FDA 
databases[Footnote 11] and interviewed officials from FDA's Center for 
Devices and Radiological Health and Office of Regulatory Affairs, which 
each have responsibilities for managing the medical device inspection 
program. We also obtained updated information from FDA on the status of 
FDA's programs for third-party inspections in June 2009. Specifically, 
we obtained data from FDA on the number of inspections conducted by 
accredited third parties since March 11, 2004--the date when FDA first 
cleared an accredited organization to conduct inspections. 

We conducted our work in accordance with generally accepted government 
auditing standards. 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. 

Background: 

FDA's responsibilities related to medical devices include premarket and 
postmarket oversight--spanning, for example, both premarket review of 
devices and postmarket surveillance (the collection and analysis of 
data on marketed devices). As part of both premarket and postmarket 
oversight, FDA is responsible for inspecting certain foreign and 
domestic establishments to ensure they meet required manufacturing 
standards. 

Premarket Review: 

Relative to the PMA process, the 510(k) premarket review process is 
generally: 

* Less stringent. For most 510(k) submissions, clinical data are not 
required and substantial equivalence will normally be determined based 
on comparative device descriptions, including performance data. In 
contrast, in order to meet the PMA approval requirement of providing 
reasonable assurance that a new device is safe and effective, most 
original PMAs and some PMA supplements require clinical data. 

* Faster. FDA generally makes decisions on 510(k) submissions faster 
than it makes decisions on PMA submissions. FDA's fiscal year 2009 goal 
is to review and decide on 90 percent of 510(k) submissions within 90 
days and 98 percent of them within 150 days. The comparable goal for 
PMAs is to review and decide upon 60 percent of original PMA 
submissions in 180 days and 90 percent of them within 295 days. 
[Footnote 12] 

* Less expensive. The estimated cost to FDA for reviewing submissions 
is substantially lower for 510(k) submissions than for PMA submissions. 
For fiscal year 2005, for example, according to FDA the estimated 
average cost for the agency to review a 510(k) submission was about 
$18,200, while the estimate for a PMA submission was about $870,000. 
For the applicant, the standard fee provided to FDA at the time of 
submission is also significantly lower for a 510(k) submission than for 
a PMA submission. In fiscal year 2009, for example, the standard fee 
for 510(k) submissions is $3,693, while the standard fee for original 
PMA submissions is $200,725. 

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 
stringent 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 13] However, certain types of 
class III devices that were in commercial distribution in the United 
States before May 28, 1976[Footnote 14] (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 15] Prior to 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.[Footnote 16] The Safe Medical 
Devices Act of 1990 required FDA (1) to reexamine 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 17] Accordingly, 
all class III devices are eventually to be reviewed through the PMA 
process. 

Postmarket Surveillance: 

In addition to its responsibilities for premarket review of devices, 
FDA's postmarket activities to help ensure that devices already on the 
market remain safe and effective include collecting and analyzing 
reports of device-related adverse events and reviewing annual reports 
required from manufacturers.[Footnote 18] FDA's reporting framework for 
device-related adverse events includes both mandatory and voluntary 
components. Under FDA's Medical Device Reporting regulation, 

* manufacturers are required to report device-related deaths, serious 
injuries, and certain malfunctions to FDA and: 

* user facilities, such as hospitals and nursing homes, are required to 
report device-related deaths to FDA and to the device manufacturer and 
to report serious injuries to the manufacturer (or, if the manufacturer 
is unknown, to FDA). 

[End of section] 

Manufacturers and user facilities, as well as health professionals and 
consumers, may also voluntarily report less serious device-related 
events to FDA. FDA maintains databases that include both mandatory and 
voluntary reports of device-related adverse events, which agency 
officials can search to conduct research on trends or emerging problems 
with device safety. FDA scientists review these reports, request follow-
up investigations, and determine whether further action is needed to 
ensure patient safety. Such action may include product recalls, public 
health advisories to notify health care providers and the public of 
potential device-related health and safety concerns, or requiring a 
manufacturer to change the instructions in its device labeling. 

Inspections of Device Manufacturing Establishments: 

Finally, as part of both premarket and postmarket oversight of medical 
devices, FDA is responsible for inspecting certain foreign and domestic 
establishments to ensure they meet required manufacturing 
standards.[Footnote 19] Such inspections are FDA's primary means of 
assuring that the safety and effectiveness of devices are not 
jeopardized by poor manufacturing practices. Requirements governing 
domestic and foreign inspections differ. Specifically, FDA is required 
to inspect domestic establishments that manufacture class II or III 
devices every 2 years.[Footnote 20] There is no comparable requirement 
to inspect foreign establishments. 

In 2002, in response to concerns about FDA's ability to meet its 
responsibilities for inspecting device manufacturing establishments, 
Congress included certain provisions in the Medical Device User Fee and 
Modernization Act of 2002 (MDUFMA).[Footnote 21] These provisions were 
designed to (1) increase the number of inspected device manufacturing 
establishments and (2) help device manufacturers meet the inspection 
requirements of both the United States and foreign countries in a 
single inspection. Specifically, MDUFMA required FDA to accredit third- 
party organizations to conduct inspections of certain foreign and 
domestic establishments. In response, FDA implemented its Accredited 
Persons Inspection Program, which permits certain establishments to 
voluntarily request inspections from third-party organizations to meet 
inspectional requirements. Additionally, in September 2006, in 
partnership with Health Canada,[Footnote 22] FDA established another 
program for inspection by accredited third parties--the Pilot Multi- 
purpose Audit Program--that allows accredited organizations to conduct 
a single inspection to meet the regulatory requirements of both 
countries. 

FDA Has Not Ensured That All Class III Devices Are Approved through the 
Most Stringent Premarket Review Process: 

Although Congress envisioned that all class III devices would 
eventually be approved through the more stringent PMA process, we found 
that this was not always the case. In January 2009, we reported that in 
fiscal years 2003 through 2007, FDA reviewed all submissions for class 
I and II devices through the 510(k) process, and reviewed submissions 
for some types of class III devices through the 510(k) process and 
others through the PMA process.[Footnote 23] 

* FDA reviewed all 13,199 submissions for class I and class II devices 
through the 510(k) process, clearing 11,935 (90 percent) of these 
submissions. 

* FDA also reviewed 342 submissions for class III devices through the 
510(k) process, clearing 228 (67 percent) of these submissions. 

* In addition, the agency reviewed 217 original PMA submissions and 784 
supplemental PMA submissions for class III devices and approved 78 
percent and 85 percent, respectively, of these submissions. 

[End of section] 

Table 1 summarizes the FDA review decisions, by class of device, in 
fiscal years 2003 through 2007 for 510(k) and PMA submissions. 

Table 1: FDA 510(k) and PMA Decisions by Class, Fiscal Years 2003 
through 2007: 

Submission type: 510(k); 
Device class: Class I; 
Determined substantially equivalent or approved (percentage of row): 
1,265 (84); 
Determined not substantially equivalent or denied (percentage of row): 
40 (3); 
Other decision[A](percentage of row): 204 (14); 
Total (percentage of row): 1,509 (100). 

Submission type: 510(k); 
Device class: Class II; 
Determined substantially equivalent or approved (percentage of row): 
10,670 (91); 
Determined not substantially equivalent or denied (percentage of row): 
373 (3); 
Other decision[A](percentage of row): 647 (6); 
Total (percentage of row): 11,690 (100). 

Submission type: 510(k); 
Device class: Class III; 
Determined substantially equivalent or approved (percentage of row): 
228 (67); 
Determined not substantially equivalent or denied (percentage of row): 
100 (29); 
Other decision[A] (percentage of row): 14 (4); 
Total (percentage of row): 342 (100). 

Submission type: 510(k); 
Device class: Other[B]; 
Determined substantially equivalent or approved (percentage of row): 
476 (33); 
Determined not substantially equivalent or denied (percentage of row): 
27 (2); 
Other decision[A](percentage of row): 955 (66); 
Total (percentage of row): 1,458 (100). 

Submission type: PMA; Original; 
Device class: Class III; 
Determined substantially equivalent or approved (percentage of row): 
170 (78); 
Determined not substantially equivalent or denied (percentage of row): 
[Empty][C]; 
Other decision[A](percentage of row): 47 (22)[C]; 
Total (percentage of row): 217 (100). 

Submission type: PMA; Supplemental[D]; 
Device class: Class III; 
Determined substantially equivalent or approved (percentage of row): 
664 (85); 
Determined not substantially equivalent or denied (percentage of row): 
[Empty][C]; 
Other decision[A](percentage of row): 120 (15)[C]; 
Total (percentage of row): 784 (100). 

Source: GAO analysis of FDA data. 

Notes: Data represent 14,999 traditional and abbreviated 510(k) 
submissions, 217 original PMA submissions, and 784 supplemental PMA 
submissions for which FDA made review decisions in fiscal years 2003 
through 2007. Percentages may not sum to 100 because of rounding. 

[A] Other decisions include submissions that were withdrawn, were 
exempted by regulation, were not responsive to FDA's requests within a 
specified time frame, were forwarded to another FDA center (e.g., drugs 
or biologics), were duplicates, or were for products determined not to 
be devices. 

[B] Other device class includes submissions for which a device class 
was not recorded in FDA's 510(k) database. 

[C] According to FDA data, all PMA decisions during fiscal years 2003 
through 2007 were approved or withdrawn. FDA did not deny approval of 
any PMA submissions during this period. According to FDA officials, 
when a PMA was seriously deficient, FDA issued a "not approvable" 
letter under 21 C.F.R.  814.44(f) and placed the submission on hold. A 
company may withdraw a submission voluntarily. FDA also considers 
submissions to be withdrawn voluntarily if the applicant is unable to 
provide the information necessary to support approval within 180 days. 

[D] Supplemental PMA submissions include 180-day (user-fee) and panel- 
track PMA supplements. The numbers in this row do not include other 
types of PMA supplements. 

[End of table] 

With respect to class III devices, in fiscal years 2003 through 2007, 
FDA reviewed submissions for some types of class III devices through 
the 510(k) process, and other types of class III devices through the 
PMA process. Specifically, FDA reviewed 342 submissions for new class 
III devices through the 510(k) process, determining 228 (67 percent) of 
these submissions to be substantially equivalent to a legally marketed 
device.[Footnote 24] During the same time period, FDA reviewed 217 
original PMA submissions and 784 supplemental PMA submissions for class 
III devices and approved 78 percent and 85 percent of them, 
respectively. (See figure 1.) 

Figure 1: Class III Device Submissions with FDA Review Decisions in 
Fiscal Years 2003 through 2007, by FDA Review Process and Review 
Decision: 

[Refer to PDF for image: vertical bar graph] 

FDA review process: 510(k); 
Number of submissions cleared/approved (percentage): 228 (67%); 
Number of submissions not cleared/not approved: 114; 
Total number of submissions: 342. 

FDA review process: Original PMA; 
Number of submissions cleared/approved (percentage): 170 (78%); 
Number of submissions not cleared/not approved: 47; 
Total number of submissions: 217. 

FDA review process: Supplemental PMA; 
Number of submissions cleared/approved (percentage): 664 (85%); 
Number of submissions not cleared/not approved: 120; 
Total number of submissions: 784. 

Source: GAO analysis of FDA data. 

Notes: Figure represents FDA review decisions made between October 1, 
2002, and September 30, 2007, for class III device submissions reviewed 
through the 510(k) and PMA processes. 510(k) includes traditional and 
abbreviated 510(k) submissions; supplemental PMA includes panel-track 
supplements and 180-day (user-fee) supplements. 

Not cleared/not approved includes (1) for 510(k) submissions, those 
submissions FDA found to be not substantially equivalent or withdrawn 
and (2) for PMA submissions, those submissions that were withdrawn. 
According to FDA data, all PMA decisions during fiscal years 2003 
through 2007 were approved or withdrawn. FDA did not deny approval of 
any PMA submissions during this period. According to FDA officials, 
when a PMA is seriously deficient, FDA issues a "not approvable" letter 
and places the submission on hold. An applicant may then withdraw a 
submission voluntarily. FDA also considers submissions to be withdrawn 
voluntarily if the applicant is unable to provide the information 
necessary to support approval within 180 days. 

[End of figure] 

The 228 class III device submissions FDA cleared through the 510(k) 
process in fiscal years 2003 through 2007 were for devices such as 
artificial hip joints, implantable blood access devices, and automated 
external defibrillators. Class III 510(k) submissions were more likely 
than other 510(k) submissions to be for device types that were 
implantable; were life sustaining; or pose a significant risk to the 
health, safety, or welfare of a patient. Of the 228 510(k) submissions 
for class III devices that FDA cleared in fiscal years 2003 through 
2007, FDA's databases flagged 66 percent as being for device types that 
are implantable, life sustaining, or of significant risk. This compares 
to no 510(k) submissions for class I devices and 25 percent of 510(k) 
submissions for class II devices. 

Although the Medical Device Amendments of 1976 imposed requirements 
under which all class III devices would be approved through the PMA 
process, and the Safe Medical Devices Act of 1990 required that FDA 
either reclassify or establish a schedule for requiring PMAs for class 
III device types, this process remains incomplete. The 228 class III 
device submissions cleared by FDA through the 510(k) process in fiscal 
years 2003 through 2007 represented 24 separate types of class III 
devices. As of October 2008, 4 of these device types had been 
reclassified to class II, but 20 device types could still be cleared 
through the 510(k) process. FDA officials said that the agency is 
committed to issuing regulations either reclassifying or requiring PMAs 
for the class III devices currently allowed to receive clearance for 
marketing via the 510(k) process, but did not provide a time frame for 
doing so. 

We recommended that the Secretary of Health and Human Services direct 
the FDA Commissioner to expeditiously take steps to issue regulations 
for each class III device type currently allowed to enter the market 
through the 510(k) process. These steps should include issuing 
regulations to (1) reclassify each device type into class I or class 
II, or require it to remain in class III, and (2) for those device 
types remaining in class III, require approval for marketing through 
the PMA process. In commenting on a draft of our report, HHS agreed 
with our recommendation, noting that since 1994 (when FDA announced its 
strategy to implement provisions of the Safe Medical Devices Act of 
1990) FDA has called for PMAs or reclassified the majority of class III 
devices that did not require PMAs at that time. The department's 
comments, however, did not specify time frames in which FDA will 
address the remaining class III device types allowed to enter the 
market via the 510(k) process, stating instead that the agency is 
considering its legal and procedural options for completing this task 
as expeditiously as possible, consistent with available resources and 
competing time frames. Given that more than 3 decades have passed since 
Congress envisioned that all class III devices would eventually be 
required to undergo premarket review through the more stringent PMA 
process, we believe it is imperative that FDA take immediate steps to 
address the remaining class III device types that may still enter the 
market through the less stringent 510(k) process by requiring PMAs for 
or reclassifying them. 

In April 2009, FDA took what it termed "the first step towards 
completing the review of Class III device types predating the 1976 law, 
as was recommended by the U.S. Government Accountability Office (GAO) 
in a January 2009 report to Congress." Specifically, FDA announced that 
it was requiring manufacturers of 25 types of class III medical devices 
marketed prior to 1976 to submit safety and effectiveness information 
to the agency by August 7, 2009, so that it may evaluate the risk level 
for each device type. In the Federal Register notice announcing the 
requirement,[Footnote 25] FDA stated that once the safety and 
effectiveness information was submitted, the agency would be able to 
determine which device types would be required to undergo the agency's 
most stringent premarket review process. FDA's requirement that 
manufacturers submit safety and effectiveness information is an 
essential initial step toward implementing our recommendation and fully 
implementing the law. However, FDA did not specify a time frame for how 
quickly it will review the submitted information, determine whether to 
reclassify the device types, and require PMAs for those that remain in 
class III. 

It should be noted, however, that while the PMA process is more 
stringent than the 510(k) process, FDA can approve a device through the 
PMA process without clinical data demonstrating the safety and 
effectiveness of the device. For example, in our review of FDA's 
approval of PMAs for certain temporomandibular joint (jaw) implants, 
FDA managers overruled their review staff to approve one of the 
devices, despite the review staff's concern over the sufficiency of the 
clinical data.[Footnote 26] The review decision stated that either good 
engineering data or good clinical data--not necessarily both--were 
acceptable to approve a device and accepted the engineering data as a 
basis for approving an implanted device for which the review staff had 
determined that the clinical data were inadequate. 

FDA Faces Challenges in Postmarket Surveillance: 

In our recent high-risk report, we noted that FDA's monitoring of 
postmarket safety of approved products, including medical devices, has 
been questioned by numerous groups.[Footnote 27] In 2008, we reported 
that the number of adverse event reports associated with all devices 
increased substantially from about 77,000 reports in 2000 to about 
320,000 reports in 2006.[Footnote 28] FDA's review and analysis of 
these reports provides information about trends such as infection 
outbreaks or common user errors caused by inadequate instructions and 
may result in actions such as device recalls. During fiscal year 2006, 
FDA initiated 651 recall actions involving 1,550 medical devices. This 
included 21 recall actions in which FDA determined that it was likely 
that the use of the medical device would cause serious health problems 
or death. 

We and FDA have identified shortcomings in FDA's postmarket 
surveillances. In 2006, FDA reported that the agency's Center for 
Devices and Radiological Health's ability to understand the risks of 
adverse events related to the use of medical devices--whether used in 
the in the home of a patient, in a hospital, in a laboratory, or in the 
office of a private practitioner--is limited both by a lack of 
informative, validated adverse event reports and by a lack of quality 
epidemiologic information.[Footnote 29] FDA specifically reported: 

* One major constraint is the lack of objective data about device use 
and device-related problems. 

* Underreporting of adverse events continues to be a problem. 

* FDA's medical device reporting system is a passive system--that is, 
the reports are entered as reported by manufacturers, facilities, 
practitioners, or patients--and, as a result, some reports are 
incomplete or difficult to understand. 

* The volume of submitted reports exceeded the center's ability to 
consistently enter or review the data in a routine manner. 

In its 2006 report, FDA identified areas for improvement in postmarket 
problem assessment for the center. In 2008, FDA officials told us that 
while they have a number of strategies to prioritize their reviews, 
they still cannot review all the reports they receive. 

We have also found shortcomings in FDA's monitoring of manufacturers' 
compliance with requirements following device approval. In 2007, we 
found that manufacturers do not always submit their required annual 
reports in a timely manner. For example, FDA was missing five annual 
reports from the manufacturer of one device we were examining, but it 
was not until we requested these reports that FDA contacted the 
manufacturer to obtain the missing information.[Footnote 30] Without 
these annual reports, FDA cannot adequately monitor manufacturers' 
compliance with postmarket requirements. 

FDA Has Not Conducted Required Inspections of Manufacturing 
Establishments: 

Our work has also identified challenges faced by FDA in terms of 
inspecting establishments that manufacture medical devices. In January 
2008, we testified that FDA has not met a statutory requirement to 
inspect certain domestic manufacturing establishments every 2 years. 
[Footnote 31] FDA officials estimated that the agency has inspected 
these establishments every 3 years (for establishments manufacturing 
class III devices) or every 5 years (for establishments manufacturing 
class II devices). There is no comparable requirement to inspect 
foreign establishments, and agency officials estimate that these 
establishments have been inspected every 6 years (for class III 
devices) or 27 years (for class II devices). 

We also testified that FDA faces additional challenges in managing its 
inspections of foreign device establishments. We found that two 
databases that provide FDA with information about foreign device 
establishments and the products they manufacture for the U.S. market 
contain inaccuracies that create disparate estimates of establishments 
subject to FDA inspection.[Footnote 32] Although comparing information 
from these two databases could help FDA determine the number of foreign 
establishments marketing devices in the United States, these databases 
cannot exchange information and any comparisons must be done manually. 
Moreover, inspections of foreign device manufacturing establishments 
pose unique challenges to FDA, such as difficulties in finding 
translation services and in extending trips if the inspections uncover 
problems. FDA has taken some steps to address shortcomings related to 
inspections of foreign establishments, including changes to its 
registration database to improve the accuracy of the count of 
establishments and initiatives to address unique challenges related to 
inspections of foreign manufacturers, but we have not evaluated whether 
these changes will improve FDA's inspection program. 

In addition, FDA's accredited third-party inspection programs may be 
unable to quickly help FDA fulfill its responsibilities. In January 
2007, we reported on the status of the Accredited Persons Inspection 
Program, citing, among other things, concerns regarding its 
implementation and potential incentives and disincentives that may 
influence manufacturers' participation.[Footnote 33] We found that 
several factors may influence manufacturers' interest in voluntarily 
requesting an inspection by an accredited organization. According to 
FDA and representatives of affected entities, there are potential 
incentives and disincentives to requesting an inspection, as well as 
reasons for deferring participation in the program. Potential 
incentives include the opportunity to reduce the number of inspections 
conducted to meet FDA and other countries' requirements and to control 
the scheduling of the inspection. Potential disincentives include 
bearing the cost for the inspection and uncertainty about the potential 
consequences of making a commitment to having an inspection to assess 
compliance with FDA requirements in the near future. Some manufacturers 
might be deferring participation. For example, manufacturers that 
already contract with a specific accredited organization to conduct 
inspections to meet the requirements of other countries might defer 
participation until FDA has cleared that organization to conduct 
independent inspections. In both our January 2008 and May 2008 
testimonies, we reported that few inspections of device manufacturing 
establishments had been conducted through FDA's two accredited third- 
party inspection programs.[Footnote 34] As of June 12, 2009, FDA 
reported that a total of 21 inspections--8 inspections of domestic 
establishments and 13 inspections of foreign establishments--had been 
conducted under these programs. The small number of inspections 
completed by accredited third-party organizations raises questions 
about the practicality and effectiveness of these programs to quickly 
help FDA increase the number of establishments inspected. 

Taken together, these shortcomings in both premarket and postmarket 
activities raise serious concerns about FDA's regulation of medical 
devices. 

Mr. Chairman, this completes my prepared statement. I would be happy to 
respond to any questions you or the other members of the subcommittee 
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. Kim Yamane and Geraldine Redican- 
Bigott, Assistant Directors; Susannah Bloch; Matt Byer; Sean DeBlieck; 
Helen Desaulniers; and Julian Klazkin made key contributions to this 
report. 

[End of section] 

Related GAO Products: 

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

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. 

Medical Devices: FDA Faces Challenges in Conducting Inspections of 
Foreign Manufacturing Establishments. [hyperlink, 
http://www.gao.gov/products/GAO-08-780T]. Washington, D.C.: May 14, 
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. 

Medical Devices: FDA's Approval of Four Temporomandibular Joint 
Implants. [hyperlink, http://www.gao.gov/products/GAO-07-996]. 
Washington, D.C.: September 17, 2007. 

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] Generally, medical devices include items used for the diagnosis, 
cure, mitigation, treatment, or prevention of a disease. See 21 U.S.C. 
 321(h). Throughout this statement, the term device refers to a 
medical device that is not being regulated as a drug or a biological 
product. 

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

[3] Throughout this statement, we refer to type of device or device 
type to indicate a generic category of device, which has a particular 
intended use (for example, a scalpel is intended to cut tissue) and 
which may include a variety of models made by different manufacturers. 
FDA's classifications of device types are codified in parts 862 through 
892 of title 21 of the Code of Federal Regulations. Class I devices are 
those for which compliance with general controls, such as good 
manufacturing practices specified in FDA's quality system regulation, 
are 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. 
For class II devices intended to support or sustain human life, FDA 
must examine, identify, and describe the special controls necessary to 
provide assurance of their safety and effectiveness. 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 their safety and effectiveness 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. 

[4] Under federal regulations, many types of devices are exempt from 
FDA premarket review. Although FDA does not track the number of devices 
that are actually sold or marketed in the United States, manufacturers 
are required to register with FDA and provide a list of devices 
intended for commercial distribution, including device types that are 
exempt from premarket review. See 21 U.S.C.  360(j)(2)(A); 21 C.F.R.  
807.21 (2008). About 67 percent of the more than 50,000 separate 
devices that manufacturers listed with FDA during fiscal years 2003 
through 2007 were exempt from premarket review. Of the exempt devices 
that manufacturers listed with FDA, about 95 percent were class I 
devices, for example reading glasses and forceps. About 5 percent were 
class II devices, for example wheeled stretchers and mercury 
thermometers. 

[5] 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 (2008). 

[6] 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 different technological 
characteristics and submitted information demonstrates that the device 
is as safe and effective as the legally marketed device and does not 
raise different questions of safety or effectiveness. See 21 U.S.C.  
360c(i)(1)(A). 

[7] 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). 

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

[9] The databases we used included FDA's 510(k) and premarket approval 
(PMA) databases, Device Nomenclature Management System, Device 
Registration and Listing System (DRLS), Field Accomplishments and 
Compliance Tracking System (FACTS), and Operational and Administrative 
System for Import Support (OASIS). 

[10] 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. 

[11] The FDA databases we used were DRLS, FACTS, and OASIS. 

[12] FDA's goals for original PMAs included panel-track PMA 
supplements. 

[13] See Pub. L. No. 94-295, 90 Stat. 539, 552-53 (codified at 21 
U.S.C.  360e). 

[14] May 28, 1976, is the date of enactment of the Medical Device 
Amendments of 1976, which established the three device classes. Pub. L. 
No. 94-295, 90 Stat. 539. 

[15] Based on new information respecting a device, FDA may, upon its 
initiative or upon petition of an interested person, 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). 

[16] In August 1988, GAO reported that FDA had called for premarket 
approval applications for only 9 of approximately 150 types of 
preamendment class III device types. See GAO, Medical Devices: FDA's 
510(k) Operations Could Be Improved, [hyperlink, 
http://www.gao.gov/products/GAO/PEMD-88-14] (Washington, D.C.: Aug. 17, 
1988). 

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

[18] FDA approves some devices conditionally, meaning that as a 
condition of approval, manufacturers must comply with specific terms 
specified by FDA, such as conducting postmarket surveillance studies. 
Manufacturers report to FDA on their compliance with these conditions 
through annual reports. 

[19] FDA regulations define an establishment as a place of business 
under one management at one general physical location at which a device 
is manufactured, assembled, or otherwise processed. 21 C.F.R.  
807.3(c) (2007). Device manufacturers may have more than one 
establishment. We use the term manufacture to refer to activities 
including manufacturing, preparing, and processing devices. 

[20] 21 U.S.C.  360(h). There is no statutory requirement for 
inspection of class I device manufacturing establishments, and FDA does 
not routinely inspect them. However, FDA periodically inspects 
establishments manufacturing surgeon's gloves and patient examination 
gloves, which are both class I devices, due to ongoing problems with 
leakage. FDA also periodically inspects manufacturers of randomly 
selected class I devices. 

[21] See Pub. L. No. 107-250,  201, 116 Stat. 1588, 1602-09 (2002) 
(codified as amended at 21 U.S.C.  374(g)). 

[22] Health Canada is the governmental entity that regulates medical 
devices marketed in Canada. 

[23] See [hyperlink, http://www.gao.gov/products/GAO-09-190]. 

[24] Consumer advocates have raised questions regarding 510(k) 
clearance of devices that may utilize new technologies that are 
different than those in the marketed devices to which they are 
compared. In our review of a representative sample of 510(k) 
submissions for which FDA reached a review decision of substantially 
equivalent or not substantially equivalent in fiscal years 2005 through 
2007, we found that FDA determined 23 percent of cleared class III 
device submissions had new technological characteristics. This compares 
to 14 percent of cleared class II submissions. 

[25] See 74 Fed. Reg. 16214 (Apr. 9, 2009). 

[26] See GAO, Medical Devices: FDA's Approval of Four Temporomandibular 
Joint Implants, [hyperlink, http://www.gao.gov/products/GAO-07-996] 
(Washington, D.C.: Sept. 17, 2007). 

[27] See [hyperlink, http://www.gao.gov/products/GAO-09-271], 18. 

[28] FDA officials told us that the vast majority of reports involve a 
device malfunction that has the potential to cause a death or serious 
injury if the malfunction were to recur, even though there was no death 
or serious injury in the reported event. See GAO, Reprocessed Single- 
Use Medical Devices: FDA Oversight Has Increased, and Available 
Information Does Not Indicate That Use Presents an Elevated Health 
Risk, GAO-08-147 (Washington, D.C.: Jan. 31, 2008). 

[29] See Food and Drug Administration, Ensuring the Safety of Marketed 
Medical Devices, CDRH's Medical Device Postmarket Safety Program (Jan. 
18, 2006). 

[30] [hyperlink, http://www.gao.gov/products/GAO-07-996]. 

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

[32] These two databases are DRLS and OASIS. 

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

[34] See [hyperlink, http://www.gao.gov/products/GAO-08-428T] and GAO, 
Medical Devices: FDA Faces Challenges in Conducting Inspections of 
Foreign Manufacturing Establishments, [hyperlink, 
http://www.gao.gov/products/GAO-08-780T] (Washington, D.C.: May 14, 
2008). 

[End of section] 

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