Report to Congressional Addressees

United States Government Accountability Office

GAO 

MEDICAL DEVICES

FDA Should Take 

Steps to Ensure That 

High-Risk Device 

Types Are Approved 

through the Most 

Stringent Premarket 

Review Process 

January 2009 

GAO-09-190 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

January 2009

MEDICAL DEVICES

FDA Should Take Steps to Ensure That High-Risk 

Device Types Are Approved through the Most 

Highlights of GAO-09-190, a report to Stringent Premarket Review Process

congressional addressees

The Food and Drug Administration 

(FDA) within the Department of 

Health and Human Services (HHS)

is responsible for oversight of 

medical devices sold in the United

States. Regulations place devices

into three classes, with class III 

including those with the greatest 

risk to patients. Unless exempt by 

regulation, new devices must clear 

FDA premarket review via either 

the 510(k) premarket notification 

process, which determines if 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. 

Class III devices must generally

obtain an approved PMA, but until 

FDA issues regulations requiring

submission of PMAs, certain types 

of class III devices may be cleared 

via the 510(k) process. The FDA 

Amendments Act of 2007 mandated 

that GAO study the 510(k) process.

GAO examined which premarket

review process—510(k) or PMA—

FDA used to review selected types 

of device submissions in fiscal 

years 2003 through 2007. GAO 

reviewed FDA data and regulations, 

and interviewed FDA officials. 

What GAO Recommends

GAO recommends that FDA 

expeditiously take steps to issue 

regulations for class III device

types currently allowed to enter the 

market via the 510(k) process by

requiring PMAs or reclassifying

them to a lower class. HHS agreed

with GAO’s recommendation. 

In fiscal years 2003 through 2007, as part of its premarket review to determine 

whether devices should be permitted to be marketed in the United States, 

FDA 

• reviewed 13,199 submissions for class I and II devices via the 510(k) 

process, clearing 11,935 (90 percent) of these submissions; 

• reviewed 342 submissions for class III devices through the 510(k) process, 

clearing 228 (67 percent) of these submissions; and 

• reviewed 217 original and 784 supplemental PMA submissions for class III 

devices and approved 78 percent and 85 percent, respectively, of these 

submissions. 

Although Congress envisioned that class III devices would be approved 

through the more stringent 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. GAO found 

that in fiscal years 2003 through 2007 FDA cleared submissions for 24 types of

class III devices through the 510(k) process. 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. 

Class III Device Submissions with FDA Review Decisions in Fiscal Years 2003 through 2007, 

by FDA Review Process and Review Decision 

0

100

200

300

400

500

600

700

800

900

Not cleared/not approved Cleared/approved

Supplemental

 PMA

Original

PMA

510(k)

n = 342

n = 784

n = 217 114

120

47

228

664 85%

approved

170

Number of submissions

FDA review process

67%

cleared 78%

approved

Source: GAO analysis of FDA data.

Notes: 510(k) includes traditional and abbreviated 510(k) submissions. Supplemental PMA includes 

certain types of submissions for changes to devices that were previously approved through the PMA 

process. Not cleared/not approved includes 510(k) submissions that were denied or other (e.g., 

withdrawn) and PMAs that were withdrawn or otherwise not approved. 

To view the full product, including the scope 

and methodology, click on GAO-09-190. 

For more information, contact Marcia Crosse 

at (202) 512-7114 or crossem@gao.gov. 
Contents 

Letter 1

Results in Brief 6

Background 7

FDA Used the 510(k) Process to Review Class I and II Device

Submissions, and Used Both the 510(k) and PMA Processes to 

Review Class III Device Submissions 16 

Relatively Few Class II and Class III 510(k) Submissions Had a 

New Intended Use or New Technological Characteristics 23 

Conclusions 27

Recommendation for Executive Action 28 

Agency Comments 28 

Appendix I Scope and Methodology 30 

Appendix II Third-Party Review of 510(k) Submissions 37 

Appendix III FDA’s Implementation of Safe Medical Devices 

Act Provisions 41 

Appendix IV Additional Information on 510(k) Submissions 

for Class III Devices Reviewed by FDA 44 

Appendix V FDA’s 510(k) Decision-Making Process 50 

Appendix VI Comments from the Department of Health 

and Human Services 54 

Appendix VII GAO Contact and Staff Acknowledgments 56 

Page i GAO-09-190 Medical Device Premarket Review
Related GAO Products 57 

Tables 

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

2003 through 2007 17 

Table 2: FDA Review Decisions for 510(k) Submissions for Class I 

and Class II Devices, by Fiscal Year (2003-2007) 18 

Table 3: 510(k) Submissions for Class I and Class II Devices 

Cleared in Fiscal Years 2003 through 2007 19 

Table 4: Number of Submissions for Class III Devices Cleared 

through the 510(k) Process in Fiscal Years 2003 through 

2007 21 

Table 5: Characteristics of Cleared 510(k) Submissions, Fiscal 

Years 2005 through 2007 26 

Table 6: Characteristics of 510(k) Submissions for Devices FDA 

Determined NSE in Fiscal Years 2005 through 2007 27 

Table 7: Scope of File Review by 510(k) Submission Type, Review 

Decision, and FDA Office or Center 32 

Table 8: Cases Reviewed, by Fiscal Year 33 

Table 9: Cases Reviewed, by Class and SE/NSE Determination 33 

Table 10: Third-Party Review 510(k) Submissions with FDA 

Decisions, Fiscal Years 2003 through 2007 39 

Table 11: Third-Party Review 510(k) Submissions by Medical 

Specialty, Fiscal Years 2003 through 2007 40 

Table 12: FDA Groupings and Time Frames for Implementation of 

SMDA Provisions for Class III Device Types in 1994 and 

Status as of October 2008 42 

Table 13: FDA Review Decisions for Class III 510(k) Submissions 

by Fiscal Year, Fiscal Years 2003 through 2007 44 

Table 14: Primary Medical Specialties of Class III 510(k) 

Submissions Cleared in Fiscal Years 2003 through 2007 45 

Table 15: Device Types with Class III 510(k) Submissions Cleared 

in Fiscal Years 2003 through 2007 and Their Status as of 

October 2008 46 

Page ii GAO-09-190 Medical Device Premarket Review
Figures 

Figure 1: Devices That Manufacturers Listed with FDA during 

Fiscal Years 2003 through 2007, by Review Process and 

Device Class 9 

Figure 2: FDA’s 510(k) Decision-Making Process 14 

Figure 3: Class III Device Submissions with FDA Review Decisions 

in Fiscal Years 2003 through 2007, by FDA Review 

Process and Review Decision 20 

Figure 4: Proportion of Cleared 510(k) Submissions for Class III 

Devices Flagged as Implantable, Life Sustaining, or of 

Significant Risk, Review Decisions Made in Fiscal Years 

2003 through 2007 22 

Figure 5: Projected Percentages of 510(k) Submissions for Class II 

and Class III Devices in Fiscal Years 2005 through 2007 

Reaching Each Point in FDA’s Decision-Making Process 24 

Figure 6: 510(k) Submissions Cleared in Fiscal Years 2005 through 

2007, by Technological Characteristics 25 

Figure 7: Detailed Version of FDA’s 510(k) Decision-Making 

Process 34

Figure 8: Simplified Version of FDA’s 510(k) Decision-Making 

Process 35

Figure 9: Projected Percentages of 510(k) Submissions for Class II 

and Class III Devices in Fiscal Years 2005 through 2007 

Reaching Each Point in FDA’s Detailed Decision-Making 

Process 51

Figure 10: Projected Percentages of 510(k) Submissions for Class II 

Devices in Fiscal Years 2005 through 2007 Reaching Each 

Point in FDA’s Decision-Making Process 52 

Figure 11: Percentages of 510(k) Submissions for Class III Devices 

in Fiscal Years 2005 through 2007 Reaching Each Point in 

FDA’s Decision-Making Process 53 

Page iii GAO-09-190 Medical Device Premarket Review
Abbreviations 

FDA Food and Drug Administration 

FDCA Federal Food, Drug, and Cosmetic Act 

HHS Department of Health and Human Services 

NSE not substantially equivalent 

PMA premarket approval 

SE substantially equivalent 

SMDA Safe Medical Devices Act of 1990 

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

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necessary if you wish to reproduce this material separately. 

Page iv GAO-09-190 Medical Device Premarket Review
United States Government Accountability Office

Washington, DC 20548 

 

January 15, 2009 

The Honorable Edward M. Kennedy 

Chairman 

The Honorable Michael B. Enzi 

Ranking Member 

Committee on Health, Education, Labor, and Pensions 

United States Senate 

The Honorable Henry A. Waxman 

Chairman 

The Honorable Joe Barton 

Ranking Member 

Committee on Energy and Commerce 

House of Representatives 

The Honorable Charles E. Grassley 

United States Senate 

The Honorable John D. Dingell 

House of Representatives 

The federal government, through the Food and Drug Administration (FDA) 

within the Department of Health and Human Services (HHS), is 

responsible for ensuring that medical devices sold in the United States 

provide reasonable assurance of safety and effectiveness and do not pose 

a threat to public health.1

 These devices range from simple tools like 

bandages and surgical clamps to complicated devices like pacemakers. 

FDA classifies each device type into one of three classes—class I, II, or 

III—based on the level of risk it poses and the controls necessary to 

 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 report, the 

term device refers to a medical device that is not being regulated as a drug or a biological 

product. 

Page 1 GAO-09-190 Medical Device Premarket Review
 

reasonably ensure its safety and effectiveness.2 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, devices are subject to 

one of two types of FDA premarket review before they may be legally 

marketed in the United States.3

• 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. 

 2

Throughout this report 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; in addition, FDA’s Web site provides searchable databases at

www.fda.gov/cdrh/databases.html. 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. Class II devices may support or sustain human life. For 

class II devices that are represented or purported to be used for those purposes, 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 a

reasonable assurance of the safety and effectiveness of the devices 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. 

3

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). 

Page 2 GAO-09-190 Medical Device Premarket Review
 

• Premarket notification (510(k)): 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.4

 A successful 

submission results in FDA clearance.5

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. However, certain types of class III devices that 

were in commercial distribution in the United States before May 28, 19766

(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.7

 The Safe

Medical Devices Act of 1990 (SMDA) 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.8

 Accordingly,

all class III devices are eventually to be reviewed through the PMA 

process. 

 4

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). 

5

Some devices are exempt from premarket notification requirements. Most class I and 

some class II device types are in this exempt category. In these cases, the manufacturers 

must still register and list the devices with FDA. 

6

May 28, 1976, is the date of enactment of the Medical Device Amendments of 1976, which 

established the three device classes. See Pub. L. No. 94-295, 90 Stat. 539. 

7

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. See 21 U.S.C. § 360c(e). 

8

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

Page 3 GAO-09-190 Medical Device Premarket Review
 

The FDA Amendments Act of 20079 mandated that GAO study FDA’s 

premarket review of devices under section 510(k) of the Federal Food, 

Drug, and Cosmetic Act (FDCA).10 This report discusses (1) the premarket 

review process—510(k) or PMA—FDA used to review class I, II, and III 

device submissions in fiscal years 2003 through 2007 and (2) the extent to

which FDA has determined that devices reviewed through the 510(k) 

process had new intended uses or new technological characteristics. 

To determine the premarket review process FDA used to review class I, II, 

and III device submissions, as well as the number of submissions reviewed 

and cleared in fiscal years 2003 through 2007, we obtained and analyzed

data from FDA’s 510(k) and PMA databases. These databases contain 

information on 510(k) and PMA submissions,11 respectively, including the 

name of the device, the FDA-assigned product code,12 the status of the 

submission, and any FDA decisions related to the submission and the 

dates of those decisions. We also used data from FDA’s Device 

Nomenclature Management System to determine other attributes of the 

device types covered by the 510(k) and PMA submissions. We obtained

and analyzed data on submissions for which FDA made review decisions 

in fiscal years 2003 through 2007.13 Our analysis included traditional and 

abbreviated 510(k) submissions, original PMA submissions, and 

submissions for certain types of PMA supplements (panel-track and 

 9

Pub. L. No. 110-85, § 225, 121 Stat. 823, 854. 

1021 U.S.C. § 360(k). 

11Throughout this report, we refer to both submissions to FDA through the 510(k) process

and applications to FDA through the PMA process as device submissions. Because related 

devices can be “bundled” together in a single submission, one submission may include one

or more devices.

12The FDA-assigned product code for a device is based on the classification designated 

under the relevant classification regulations. 

13For the purposes of this report, submissions for which FDA made review decisions

include cases in which FDA made a determination to allow or disallow marketing of a 

device and cases in which FDA decided to discontinue consideration for other reasons

such as if the manufacturer withdrew its submission. See app. I for additional information

on our scope and methodology. 

Page 4 GAO-09-190 Medical Device Premarket Review
 

180-day user-fee supplements).14 To assess the reliability of these data, we 

interviewed FDA officials knowledgeable about these databases, 

performed electronic testing for accuracy and completeness, and where 

applicable compared our results to aggregate information from other 

sources, such as published FDA reports and the FDA Web site. We 

determined that the data were sufficiently reliable for the purposes of this 

report.15

To examine the extent to which FDA has determined that devices 

reviewed through the 510(k) process had new intended uses or new 

technological characteristics, we used FDA’s 510(k) database to select and 

review all class III 510(k) submission files and a stratified random sample 

of class II 510(k) submission files for which FDA reached a determination 

of substantially equivalent (SE) or not substantially equivalent (NSE) in 

fiscal years 2005 through 2007. The sample totaled 459 submissions to the 

Office of Device Evaluation within FDA’s Center for Devices and 

Radiological Health and did not include submissions to other FDA offices 

or centers.16 In each case, we collected data primarily from the FDA 

reviewer’s memo, which outlined the decisions that FDA made to reach its 

determination and summarized FDA’s rationale for finding the submission 

SE or NSE. Because our sample of class II device submissions is 

representative of all class II device submissions meeting our selection 

criteria, in reporting the results of our analysis we provide estimates for 

the universe of all 4,900 traditional and abbreviated 510(k) submissions for 

class II devices for which FDA made determinations of SE or NSE in fiscal 

years 2005 through 2007. To assess the reliability of the data we obtained

from FDA’s files, we compared our results with information from FDA’s 

510(k) database. In addition, we discussed cases where the determination 

path or rationale was unclear with knowledgeable FDA officials. We 

 14Our analysis did not include certain types of device submissions, for example, special 

510(k) submissions, which are requests for clearance of modifications to devices that have 

already been cleared through the 510(k) process. Panel-track PMA supplements are 

requests for approval for a significant change in design, performance, or use of a device, for 

which clinical data are generally necessary to provide a reasonable assurance of safety and 

effectiveness; 180-day PMA supplements are requests for approval for a significant change

in components, materials, design, specification, software, color additive, or labeling. 

15See app. I for additional information on our scope and methodology. 

16See app. I for additional information on our scope and methodology. Some 510(k) 

submissions may be reviewed by third parties. For additional information on third-party 

review of 510(k) submissions, see app. II. 

Page 5 GAO-09-190 Medical Device Premarket Review
 

determined that the data were sufficiently reliable for the purposes of this 

report. 

In addition to our data analysis, we reviewed relevant laws, regulations, 

and FDA guidance, and interviewed FDA officials, representatives of 

professional associations representing device manufacturers, and 

consumer advocates. We conducted this performance audit from March

2008 to January 2009 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. 

In fiscal years 2003 through 2007, FDA reviewed all class I and II device

submissions through the 510(k) process, and reviewed some types of 

class III device submissions through the 510(k) process and others 

through the PMA process. 

Results in Brief 

• FDA reviewed all 13,199 submissions for class I and class II devices 

through the 510(k) process, clearing 90 percent (11,935 submissions) for 

marketing. 

• FDA reviewed 342 submissions for class III devices through the 510(k) 

process, clearing 67 percent (228 submissions) for marketing. 

• FDA also reviewed 217 original PMA submissions and 784 supplemental

PMA submissions for class III devices, approving 78 percent and 

85 percent, respectively, of these submissions for marketing. 

Although Congress envisioned that class III devices would be approved 

through the more stringent PMA process, and the SMDA required that FDA 

establish a schedule for doing so, this process remains incomplete. We 

found that in the 5-year period we examined FDA cleared submissions for 

24 class III device types through the 510(k) process. These submissions 

were more likely than class I or class II submissions to be implantable or 

life sustaining, or to pose a significant risk to the health, safety, or welfare 

of a patient. As of October 2008, 4 of the 24 device types had been 

reclassified and 20 class III device types could still be cleared through the 

510(k) process. FDA officials have acknowledged the importance of 

publishing regulations requiring PMA submissions or reclassifying 

Page 6 GAO-09-190 Medical Device Premarket Review
 

preamendment class III device types. When asked for their time frame for 

doing so, however, the officials did not provide one. 

In fiscal years 2005 through 2007, FDA determined that relatively few 

class II and III devices reviewed through the 510(k) process had a new 

intended use or new technological characteristics. Of the 5,063 class II or 

class III 510(k) submissions with SE or NSE determinations in this time 

period, we estimate that about 1 percent had a new intended use and 

about 15 percent had new technological characteristics. Among devices 

FDA determined SE (and therefore cleared for marketing), all of the 

submissions had the same intended use and 86 percent had the same 

technological characteristics as a device already on the market. In 

contrast, among the 248 510(k) submissions found NSE, FDA determined 

that more than half of the devices had a new intended use or new 

technological characteristics. 

We are recommending that FDA expeditiously take steps to issue 

regulations for each class III device type currently allowed to enter the 

market through the 510(k) process, including (1) reclassifying each device

type into a lower class or requiring it to remain in class III and (2) for 

those device types remaining in class III, requiring approval for marketing 

through the PMA process. HHS commented that the draft report fairly and 

accurately describes the FDA’s medical device 510(k) program and the 

department agreed with our conclusions and recommendation. 

The Medical Device Amendments of 1976 established three classes of 

medical devices.17 Under current law, these three device classes are 

defined as follows: 

Background 

• 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, patient registries, or 

 17Pub L. No. 94-295, § 2, 90 Stat. 539-41 (codified as amended at 21 U.S.C. § 360c(a)(1)). 

Page 7 GAO-09-190 Medical Device Premarket Review
 

specific FDA guidelines, if general controls alone are insufficient to 

provide reasonable assurance of the device’s safety and effectiveness.18

• Class III devices are subject to general controls, but are distinguished from 

class I and II devices because class III devices are those (1) for which 

insufficient information exists to determine whether general and special

controls are sufficient to provide a 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. 

Under federal regulations, many types of devices are exempt from FDA 

premarket review.19 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.20 As shown in figure 1, about 67 percent of the more 

than 50,000 separate devices that manufacturers listed with FDA during 

Devices Exempt from FDA 

Premarket Review 

 18Before 1990, class II devices were defined as those for which general controls alone were

insufficient to provide reasonable assurance of safety and effectiveness, but for which 

sufficient information existed for FDA to establish a “performance standard” to provide

such assurance. Under the SMDA, this definition was revised to include those devices for 

which sufficient information existed for FDA to establish “special controls”—such as

performance standards, postmarket surveillance, patient registries, guidelines, and FDA 

recommendations—to provide such assurance. 

19Each manufacturer that wants to market a class I, II, or III device intended for human use 

for which premarket approval is not required must obtain marketing clearance by a 510(k) 

submission unless FDA issues a regulation stating that the device type is exempt from the

510(k) premarket notification requirements of the FDCA. 

20Manufacturers are required to register with FDA within 30 days after operations begin and 

provide it with a list at that time of their devices intended for commercial distribution.

Registrations and device listings must be updated annually. 21 U.S.C. § 360(j)(2)(A); 

21 C.F.R. § 807.21 (2008). 

Page 8 GAO-09-190 Medical Device Premarket Review
 

fiscal years 2003 through 2007 were exempt from premarket review.21 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.

Figure 1: Devices That Manufacturers Listed with FDA during Fiscal Years 2003 through 2007, by Review Process and Device 

Class 

67%

31%

1%

Othera

1%

PMA

510(k)

Exempt 95%

5%

Class II

Class I

Source: GAO analysis of FDA data.

Notes: Data are for the 50,189 devices listed with FDA by device manufacturers during the period 

October 1, 2002, through September 30, 2007. Even if their devices are exempt from premarket 

notification requirements, manufacturers must still comply with other FDA requirements, such as good 

manufacturing practice requirements specified in FDA’s quality system regulation. See 21 C.F.R. 

pt. 820 (2008). 

 21Regarding the devices listed with FDA that were not exempt from premarket review, 

about 31 percent (15,472) of the listed devices were allowed to enter the U.S. market

through the 510(k) premarket notification process, and about 1 percent (529) of the listed 

devices were required to enter the U.S. market through the more stringent PMA process.

Approximately 1 percent (389) were allowed to enter the market via other means, such as 

through the humanitarian device exemption process. A humanitarian device exemption

requires a submission that is similar to a PMA submission, but does not include 

effectiveness requirements. FDA approval of a humanitarian device exemption authorizes 

the manufacturer to market a device intended to benefit patients in the treatment or 

diagnosis of a disease or condition that affects fewer than 4,000 individuals in the United 

States per year. See 21 U.S.C. § 360j(m); 21 C.F.R. pt. 814, subpart H. 

Page 9 GAO-09-190 Medical Device Premarket Review
 

a

Other includes devices that were allowed to enter the market via 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. 

Premarket Review Process 

for Class III Devices 

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.22

However, when it passed the 1976 amendments, Congress distinguished 

between those devices in commercial distribution before the date of 

enactment and those entering the market on or after enactment. 

• Preamendment devices. Class III devices that were in commercial 

distribution prior to May 28, 1976 (referred to as preamendment devices) 

were allowed to be reviewed and cleared for the U.S. market without PMA 

approval until FDA published final regulations requiring each device type

to obtain approval for the U.S. market through the PMA process.23

• Postamendment devices. Devices that were not in commercial 

distribution prior to May 28, 1976 (referred to as postamendment devices) 

were classified automatically into class III and required to go through the 

PMA process unless FDA either (1) determined they were substantially 

equivalent to a preamendment device type for which premarket approval

is not required24 or (2) reclassified the device type into class I or class II.25

Within this framework, Congress thus envisioned that class III devices 

would be approved through the more stringent PMA process and that the 

premarket review of class I and class II devices would entail a lesser 

degree of scrutiny. 

 22Pub. L. No. 94-295, 90 Stat. 539, 552-53 (codified at 21 U.S.C. § 360e). 

23The act required FDA to promulgate regulations providing for the premarket approval of 

preamendment class III devices. 

24For both preamendment and postamendment class III devices, after FDA issues a 

regulation setting an effective date requiring PMAs for a particular device type, all devices 

of that type must obtain an approved PMA to remain on the market. In addition, any new

devices of the same type subsequently entering the market must also go through the PMA 

process—that is, they are no longer allowed to be cleared through the 510(k) process.

25After FDA reclassifies the device type into a lower class, the class I or class II device type

would require clearance for the U.S. market through the 510(k) process unless FDA also

exempted the device type from premarket notification requirements. 

Page 10 GAO-09-190 Medical Device Premarket Review
 

By the late 1980s, FDA had not acted to require PMAs for many 

preamendment class III device types.

26 In 1990, the SMDA required FDA to 

1. before December 1, 1995, order industry submission of safety and 

effectiveness information for preamendment class III device types that 

were not yet required to go through the PMA process; 

2. after ordering industry submission of safety and effectiveness 

information but before December 1, 1995, publish regulations for each 

such device either revising its classification into class I or class II or 

requiring it to remain in class III;27 and

3. as promptly as is reasonably achievable, but not later than 12 months 

after the effective date of a regulation requiring a device to remain in 

class III, establish a schedule for the promulgation of regulations 

requiring the submission of PMAs for the preamendment class III 

device types required to remain in class III.28

The House of Representatives report accompanying the SMDA stated that

“In formulating these schedules, the FDA should take into account its 

priorities and limited resources, together with the Committee’s intention 

that the evaluation process be expeditious.”29

 26For example, in 1988, GAO reported that FDA had called for premarket approval 

applications for only 9 of approximately 150 types of preamendment class III devices. See 

GAO, Medical Devices: FDA’s 510(k) Operations Could Be Improved, GAO/PEMD-88-14 

(Washington, D.C.: Aug. 17, 1988). 

27The SMDA required that (1) FDA publish a proposed regulation regarding the 

classification of the device and provide reasonable opportunity for the submission of 

comments and (2) the final regulations regarding classification could not take effect until 

90 days after the publication of a proposed regulation in the Federal Register. 

2821 U.S.C. § 360e(i)(3). The SMDA required the schedule to be established within 

12 months of the effective date of the regulation requiring a device to remain in class III. 

Under the FDCA, in order to require PMAs for preamendment class III devices, FDA must 

take a number of steps, including publishing a notice of proposed rule making, allowing 

comments on the proposed rule, providing an opportunity to request reclassification of the 

device based on new information, and then publishing a final regulation requiring 

submission of PMAs. 21 U.S.C. § 360e(b). 

29H.R. Rep. No. 101-808, at 6320 (1990). 

Page 11 GAO-09-190 Medical Device Premarket Review
 

In May 1994, FDA published a notice in the Federal Register announcing a 

strategy for implementation of the SMDA.30 According to the FDA 

memorandum outlining this strategy, the agency planned the following: 

• To publish proposed regulations by 1996 requiring PMAs for 15 device 

types that FDA had determined to present an unreasonably high risk to 

public health because significant issues of safety or effectiveness or both 

were not being resolved or, to the best of FDA’s knowledge, had little 

probability of being resolved. According to FDA, the timetable for 

publication of each final regulation would be based on specific data needs, 

comments received (in response to the proposed rule), and the existence, 

if any, of petitions received to reclassify the devices. 

• To order manufacturers to submit information on safety and effectiveness 

by 1998 for 58 device types. FDA identified 27 of these device types as not 

presenting as great a risk to the public health in light of FDA’s knowledge 

and experience with the devices. FDA identified the other 31 device types

as strong candidates for reclassification. FDA’s strategy stated that after 

receipt of the safety and effectiveness information, the agency would 

proceed with rule making to either reclassify the devices or retain them in

class III. 

• To issue one proposed regulation in 1994 requiring PMAs for 44 device 

types in limited use. 

The agency’s strategy established a plan to start addressing the class III 

device types that were allowed to go through the 510(k) process, but it did 

not establish completion dates for doing so. See appendix III for additional 

information on the FDA strategy. 

As a general rule, devices are subject to 510(k) premarket review unless 

exempt or required to go through the PMA process. Specifically, the 510(k) 

process, established in 1976, requires a device manufacturer to notify FDA 

90 days before it intends to market a device and to establish that the 

device is substantially equivalent to a legally marketed device that does 

not require a PMA. The legally marketed device is referred to as a 

predicate device. Under federal regulations, a predicate device can be a

device that 

FDA’s 510(k) Review 

Process 

 3059 Fed. Reg. 23731 (May 6, 1994). 

Page 12 GAO-09-190 Medical Device Premarket Review
 

• was legally marketed prior to May 28, 1976, for which a PMA is not 

required; or

• was marketed on or after May 28, 1976, and was found to be substantially 

equivalent to a legally marketed device through the 510(k) process; or 

• was reclassified by FDA from class III to class II or I.31

FDA reviews each 510(k) submission to determine whether the device in 

question is SE or NSE to a predicate device.

32 To be SE, a device must 

(1) have the same intended use as the predicate device and (2) have the 

same technological characteristics as the predicate device or have 

different technological characteristics and submitted information 

demonstrates that the device is as safe and effective as the marketed 

device and does not raise different questions of safety or effectiveness. 

Because the predicate device may be a device that was marketed on or 

after May 28, 1976, that was found SE when compared to another legally

marketed device through the 510(k) process, there could be multiple 

iterations of a given device type cleared through the 510(k) process. As a 

result, a 510(k) submission for a new device in 2008 could be compared to 

the 20th iteration of a device type that was on the market before 1976. 

Figure 2 shows FDA’s 510(k) decision-making process. 

 3121 C.F.R. § 807.92 (a)(3) (2008). Anyone submitting a 510(k) for a device type that has not 

been previously classified and which FDA subsequently classifies into class III, may, within

30 days after receiving notice of such classification, request that FDA reclassify the device 

under the statutory criteria for class I and class II devices. This process, known as the 

de novo classification process, permits FDA to establish a class I or II designation for 

devices that do not have a predicate and to allow them to enter the U.S. market and to

serve as a predicate device for subsequent 510(k) submissions. 21 U.S.C. § 360c(f)(2). 

32In addition to an FDA determination of SE or NSE, FDA may decide to discontinue its

review for other reasons, for example, if the manufacturer withdraws its submission. 

Page 13 GAO-09-190 Medical Device Premarket Review
 

Figure 2: FDA’s 510(k) Decision-Making Process 

Notes: In cases where FDA determines that a new device has new technological characteristics that 

could not affect safety and effectiveness, the device may be determined SE if descriptive 

characteristics alone are precise enough to ensure equivalence. In cases where FDA determines that

a new device has new technological characteristics that could affect safety and effectiveness, FDA 

requires performance data to demonstrate substantial equivalence. For cases in which descriptive or 

performance information is insufficient, FDA requests additional information. 

a

For devices with new technological characteristics, FDA first examines whether the new 

technological characteristics could affect safety or effectiveness. 

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

generally: 

New device is compared 

to a predicate device

Substantially Equivalent 

(SE) 

Do descriptive or performance 

data demonstrate equivalence?

Do descriptive or 

performance data

demonstrate equivalence?

Does the new device have 

the same intended use?

Does the new device have 

the same technological 

characteristics?

Do the new technological 

characteristics raise new types

of safety or effectiveness

questions?a

Yes

Not Substantially 

Equivalent (NSE)

No

Yes

Yes

No

Yes

No

Yes

No

No

Source: GAO.

• 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.33 In 

contrast, in order to meet the PMA approval requirement of providing 

 33According to FDA, performance testing should be submitted if there are important

descriptive differences between the device and other devices of the same type or if the 

descriptive characteristics for the new device are not precise enough to ensure 

comparability. In these instances, the most appropriate bench testing, animal testing, or

both to address the performance issue should be provided, and summary information

regarding the testing should generally suffice. 

Page 14 GAO-09-190 Medical Device Premarket Review
 

reasonable assurance that a new device is safe and effective, most original 

PMAs and some PMA supplements require clinical data.34 In addition, other 

aspects of FDA’s premarket review are less stringent for 510(k) 

submissions than for PMA submissions. For example, FDA generally does

not inspect manufacturing establishments as part of the 510(k) premarket 

review process—the 510(k) review process focuses primarily on the end 

product of the manufacturing process rather than the manufacturing 

process itself. In contrast, the agency does inspect manufacturing 

establishments as part of its review of original PMA submissions.35

Manufacturing establishments that produce devices cleared through the 

510(k) process, as well as those that produce devices approved through 

the PMA process, are subject to periodic inspections under FDA’s normal 

inspection program.36

• 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.

37

• 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 

 34When clinical outcome can be reliably predicted from nonclinical data, well-designed 

bench testing or animal testing or both can be the basis for PMA approval. 

35In addition to inspecting manufacturing establishments as part of its premarket review of 

original PMA submissions, FDA may also conduct inspections as part of the approval 

process for certain types of PMA supplements. 

36For additional information on FDA’s inspection of device manufacturing establishments, 

see GAO, Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections,

GAO-08-428T (Washington, D.C.: Jan. 29, 2008), and “Related GAO Products” at the end of

this report. 

37FDA’s goals for original PMAs included panel-track PMA supplements. For 180-day PMA 

supplements, FDA’s fiscal year 2009 goal is to review and decide upon 85 percent of

submission within 180 days and 95 percent of them within 210 days. 

Page 15 GAO-09-190 Medical Device Premarket Review
 

fiscal year 2009, for example, the standard fee for 510(k) submissions is 

$3,693, while the standard fee for original PMA submissions is $200,725.38

Consumer advocates have raised questions regarding the number of 

devices, particularly class III devices, that are cleared through the 510(k) 

process and regarding the use of the 510(k) process to clear devices that 

may utilize new technologies that are different than those in the marketed 

devices to which they are compared. Officials of associations representing 

medical device manufacturers, however, have asserted that the 510(k) 

premarket review is an important tool for reviewing device submissions, 

saying that it is a rigorous process that gives FDA the flexibility to identify

and request the information it needs to assess the safety and effectiveness 

of medical devices. 

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. Specifically, 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. Although Congress envisioned that class III devices 

would be approved through the more stringent PMA process, we found 

that FDA has not published regulations requiring PMA submissions for 

some types of preamendment class III devices nor has it reclassified them. 

As a result, some types of class III devices have been cleared for the U.S. 

market through the 510(k) process. 

Table 1 summarizes the FDA review decisions, by class of device, in fiscal

years 2003 through 2007 for 510(k) and PMA submissions. 

FDA Used the 510(k) 

Process to Review 

Class I and II Device 

Submissions, and 

Used Both the 510(k) 

and PMA Processes to 

Review Class III 

Device Submissions 

 38In fiscal year 2009, the standard fee for a panel-track supplement is $150,544 and the

standard fee for a 180-day supplement is $30,109. 

Page 16 GAO-09-190 Medical Device Premarket Review
 

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

Submission type Device class 

SE or approved

(percentage of row)

NSE or denied

(percentage of row)

Other decisiona

(percentage of row) 

Total

(percentage of row)

510(k) Class I 1,265 (84) 40 (3) 204 (14) 1,509 (100)

Class II 10,670 (91) 373 (3) 647 (6) 11,690 (100)

Class III 228 (67) 100 (29) 14 (4) 342 (100)

Otherb 476 (33) 27 (2) 955 (66) 1,458 (100)

PMA 

Original Class III 170 (78) —c47 (22)c217 (100)

Supplementald Class III 664 (85) —c 120 (15)c 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. 

FDA Reviewed All 

Submissions for Class I 

and Class II Devices 

through the 510(k) Process 

FDA reviewed all class I and class II device submissions in fiscal years 

2003 through 2007 through the 510(k) process. As shown in table 2, FDA 

cleared approximately 9 out of every 10 of the 510(k) submissions for 

class I and class II devices for which FDA made review decisions during 

this time period. 

Page 17 GAO-09-190 Medical Device Premarket Review
 

Table 2: FDA Review Decisions for 510(k) Submissions for Class I and Class II 

Devices, by Fiscal Year (2003-2007) 

FDA decision

Fiscal year

SE

(percentage

of row)

NSE

(percentage

of row)

Other decisiona

(percentage

of row)

Total

(percentage

of row)

2003 2,519 (90) 72 (3) 215 (8) 2,806 (100)

2004 2,484 (92) 86 (3) 119 (4) 2,689 (100)

2005 2,395 (90) 89 (3) 164 (6) 2,648 (100)

2006 2,325 (91) 78 (3) 156 (6) 2,559 (100)

2007 2,212 (89) 88 (4) 197 (8) 2,497 (100)

Total 11,935 (90) 413 (3) 851 (6) 13,199 (100)

Source: GAO analysis of FDA data. 

Note: Percentages may not sum to 100 because of rounding. 

a

Other decisions include submissions that were withdrawn, exempted by regulation, not responsive to 

FDA’s requests within a specified time frame, forwarded to another FDA center or office, duplicates, 

or for products determined not to be devices or not actively regulated by FDA. 

Of the 10,670 510(k) submissions for class II devices that FDA cleared in 

fiscal years 2003 through 2007, FDA’s databases identified one-quarter as 

being for devices that were implantable; were life sustaining; or presented 

significant risk to the health, safety, or welfare of a patient (see table 3). Of 

these characteristics, implantable was the most frequently identified 

characteristic. In terms of 510(k) submissions for class I devices, 

according to FDA, none of the more than 1,200 510(k) submissions for 

class I devices that FDA cleared during the same time period were for 

devices that were implantable; were life sustaining; or presented 

significant risk to the health, safety, or welfare of a patient.

Page 18 GAO-09-190 Medical Device Premarket Review
 

Table 3: 510(k) Submissions for Class I and Class II Devices Cleared in Fiscal Years 2003 through 2007 

Flag

Implantable only

(percentage 

of row) 

Life sustaining

only

(percentage 

of row) 

Significant 

risk only 

(percentage

of row)

More than

one flag

(percentage

of row)

No flag 

(percentage

of row) 

Total

(percentage

of row)

Class I 0 (0) 0 (0) 0 (0) 0 (0) 1,265 (100) 1,265 (100)

Class II 1,957 (18) 266 (3) 159 (1) 235 (2) 8,053 (75) 10,670 (100)

Total 1,957 (16) 266 (2) 159 (1) 235 (2) 9,318 (78) 11,935 (100)

Source: GAO analysis of FDA data. 

Note: Percentages may not sum to 100 because of rounding. 

FDA Reviewed 

Submissions for Some 

Class III Devices Types 

through the 510(k) Process 

and Others through the 

PMA Process 

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 SE to a predicate 

device.

39 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 fig. 3.)

 39See app. IV for additional information on 510(k) submissions for class III devices 

reviewed by FDA. 

Page 19 GAO-09-190 Medical Device Premarket Review
 

Figure 3: Class III Device Submissions with FDA Review Decisions in Fiscal Years 

2003 through 2007, by FDA Review Process and Review Decision 

0

100

200

300

400

500

600

700

800

900

Not cleared/not approved

Cleared/approved

Supplemental

 PMA

Original

PMA

510(k)

n = 342

n = 784

n = 217

114

120

47

228

664 85%

approved

170

Number of submissions

FDA review process

67%

cleared 78%

approved

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 

NSE 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. 

FDA Has Not Issued 

Regulations Requiring 

PMA Submissions for 

Some Types of Class III 

Devices 

Although Congress envisioned that class III devices would be approved 

through the more stringent PMA process, and the SMDA required that FDA 

establish a schedule for doing so, this process remains incomplete. The 

228 class III submissions that FDA cleared through the 510(k) process in 

fiscal years 2003 through 2007 were allowed to undergo premarket review

through the 510(k) process because they were for preamendment class III 

device types, or those substantially equivalent to them, for which FDA had 

Page 20 GAO-09-190 Medical Device Premarket Review
 

not yet issued regulations either requiring PMA submissions or 

reclassifying them. These 228 510(k) submissions involved 24 device types 

(see table 4).

40 Of these types, 16 were included in one of the priority 

groups in FDA’s 1994 strategy for reclassifying or requiring PMAs for 

class III device types, and in particular 4 device types—accounting for 39 

of the 228 submissions—were among those that FDA identified as 

presenting an unreasonably high risk to public health. 

Table 4: Number of Submissions for Class III Devices Cleared through the 510(k) 

Process in Fiscal Years 2003 through 2007 

Group 

Number 

of device 

types

Number of 

submissions

cleared in

FYs 2003-2007 Examples 

Included in a priority 

group in FDA’s 1994 

strategy 

16 123 Certain types of hip joints, 

implanted blood access devices 

Othera8 105 Pedicle screws for certain types of 

spinal surgeries, dental implants, 

automated external defibrillator 

Total 24 228

Source: GAO analysis of FDA data. 

a

Other includes device types for which FDA had already taken some action by 1994 (for example, 

FDA indicated that it had reclassification petitions pending for some device types in 1994) as well as 

new device types that FDA established after 1994 (for example, FDA issued a new regulation for a 

subset of one device type). 

The class III submissions FDA cleared through the 510(k) process 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 (see fig. 4). This 

compares to no 510(k) submissions for class I devices and 25 percent of 

510(k) submissions for class II devices. 

 40See app. IV for additional information on 510(k) submissions for class III devices 

reviewed by FDA. 

Page 21 GAO-09-190 Medical Device Premarket Review
 

Figure 4: Proportion of Cleared 510(k) Submissions for Class III Devices Flagged as Implantable, Life Sustaining, or of 

Significant Risk, Review Decisions Made in Fiscal Years 2003 through 2007 

66%

34%

No risk flagged

Any risk flagged

Actual numbers:

Any risk flagged: 150

No risk flagged: 78

Missing data: 0

41%

8%

51%

More than one flag

Significant risk only

Implantable only

Actual numbers:

Implantable only: 62

Life-sustaining only: 0

Significant risk only: 12

More than one flag: 76

Source: GAO analysis of FDA data.

Notes: Figure represents data for 228 510(k) submissions for class III devices that FDA determined to 

be SE in fiscal years 2003 through 2007. FDA’s database flagged 150 of these submissions as

device types that were implantable; were life sustaining; presented significant risk to the health, 

safety, or welfare of a patient; or a combination of those flags. 

Four of the 24 class III device types for which FDA cleared 510(k) 

submissions in fiscal years 2003 through 2007 have since been reclassified

by FDA as class II device types.41 Twenty of the 24 device types, however, 

may still be cleared through the 510(k) process.42 Further, there are other 

preamendment class III device types that did not happen to have any 

 41For these device types, FDA determined that general controls alone were insufficient to 

provide reasonable assurance of safety and effectiveness and that sufficient information

existed to establish special controls to provide such assurance. 

42This includes two device types that FDA reclassified to class II under certain conditions, 

but retained the device type as class III that may be cleared through the 510(k) process for 

other conditions. For example, FDA reclassified endosseous dental implants to class II for 

root-form implants, but retained the blade-form implants as class III devices that may be 

cleared through the 510(k) process. 

Page 22 GAO-09-190 Medical Device Premarket Review
 

510(k) submissions cleared in fiscal years 2003 through 2007 that are also 

still eligible to be cleared through the 510(k) process. 

FDA officials have acknowledged the importance of publishing regulations 

requiring PMA submissions or reclassifying preamendment class III device 

types. When asked for their time frame for doing so, the officials did not 

provide one. Rather, they responded that that the agency is committed to 

addressing this issue as resources and priorities permit. 

In our review of 510(k) submission files for which FDA reached a 

determination of SE or NSE in fiscal years 2005 through 2007, we found 

that FDA determined that relatively few devices had a new intended use or

new technological characteristics. Overall, we found that FDA determined 

about 1 percent of class II and III submissions had a new intended use and 

about 15 percent had new technological characteristics.43 For the 510(k) 

submissions that FDA cleared, FDA found that all of the devices had the 

same intended use as their predicate devices, and 86 percent also had the

same technological characteristics. In contrast, of the 510(k) submissions 

that FDA determined to be NSE, more than half were for devices that had

a new intended use or new technological characteristics. 

Relatively Few 

Class II and Class III 

510(k) Submissions 

Had a New Intended 

Use or New 

Technological 

Characteristics 

Figure 5 shows the estimated percentage of 510(k) submissions reaching 

each step in the review process. See appendix V for additional information 

on FDA’s decision-making process. 

 43All figures are estimates based on our sample of 510(k) submissions. Our analysis of FDA 

files did not include submissions for class I devices or submissions that did not receive a

final determination, such as submissions that were withdrawn. See app. I for additional 

information on the scope of our review. 

Page 23 GAO-09-190 Medical Device Premarket Review
 

Figure 5: Projected Percentages of 510(k) Submissions for Class II and Class III Devices in Fiscal Years 2005 through 2007 

Reaching Each Point in FDA’s Decision-Making Process 

Device is compared to a

predicate device

Substantially Equivalent (SE) 

Do descriptive or performance 

data demonstrate equivalence?

Do descriptive or performance 

data demonstrate equivalence?

Does the new device have the 

same intended use?

Does the new device have the 

same technological 

characteristics?

Do the technological 

characteristics raise new types

of safety or effectiveness

questions?a

81.5% Yes

Not Substantially Equivalent 

(NSE)

4.9%b 95.1%

15.4% had new

technological

characteristics

No

98.6% Yes

83.2% Yes

14.9% No

13.6% Yes

0.7% had a new

intended use

No

0.5%

Yes

1.3%

No

1.7%

No

Source: GAO analysis of FDA files.

n = 5,063

Notes: Estimates based on GAO review of all class III and a sample of class II 510(k) submissions.

This figure includes data for 510(k) submissions for class II and class III devices that FDA determined 

to be SE and NSE in fiscal years 2005 through 2007. The sampling errors of the estimated 

percentages of 510(k) submissions reaching SE or NSE in FDA’s decision-making process are within

plus or minus 1 percentage point at the 95 percent confidence level.

In cases where FDA determines that a new device has new technological characteristics that could 

not affect safety and effectiveness, the device may be determined SE if descriptive characteristics 

alone are precise enough to ensure equivalence. In cases where FDA determines that a new device 

has new technological characteristics that could affect safety and effectiveness, FDA requires 

performance data to demonstrate substantial equivalence. For cases in which descriptive or 

performance information is insufficient, FDA requests additional information. 

a

For devices with new technological characteristics, FDA first examines whether the new 

technological characteristics could affect safety or effectiveness. 

b

Includes some submissions (0.6% of the 5,063 510(k) submissions) in which FDA made a 

determination of NSE but for which the determination path is not represented in this figure. Reasons 

that these cases were found NSE include the applicant failing to respond to an FDA data request and

a PMA already being required for the device. 

Page 24 GAO-09-190 Medical Device Premarket Review
 

All 510(k) submissions for class II and class III devices that FDA cleared in 

fiscal years 2005 through 2007 had the same intended use and most had 

the same technological characteristics as predicate devices. In all 4,815 

class II and class III submissions cleared through the 510(k) process 

during this time period, FDA determined that the new devices had the 

same intended use as their predicate devices. In 86 percent of these 

submissions, we found that FDA determined that the new devices also had 

the same technological characteristics as their predicate devices. (See 

fig. 6.) 

All 510(k) Submissions 

That FDA Cleared Had the 

Same Intended Use and 

Most Had the Same 

Technological 

Characteristics as 

Predicate Devices 

Figure 6: 510(k) Submissions Cleared in Fiscal Years 2005 through 2007, by 

Technological Characteristics 

86%

14%

Same technological

characteristics

New technological 

characteristics

Source: GAO analysis of FDA files.

Notes: Data are estimated results for 4,815 submissions based on a sample of submissions for 

class II and class III devices cleared by FDA during fiscal years 2005 through 2007. The sampling 

errors of the estimated percentages in this chart are within plus or minus 5 percentage points at the 

95 percent confidence level. 

In 14 percent of the class II and class III submissions cleared through the 

510(k) process in fiscal years 2005 through 2007, FDA determined that the 

new device had new technological characteristics. For the cleared 

submissions with new technological characteristics, FDA determined, 

among other things, that either 

1. the new technological characteristics could not affect safety or 

effectiveness—for example, FDA determined that software 

modifications to a defibrillator allowing physicians greater control 

over the device’s CPR (cardiopulmonary resuscitation) settings could 

not affect the safety or effectiveness of the defibrillator—or 

Page 25 GAO-09-190 Medical Device Premarket Review
 

2. the new characteristics do not raise new types of safety or 

effectiveness questions—for example, FDA determined that a digital 

electrocardiograph did not raise new types of effectiveness questions 

relative to the predicate device, an analog electrocardiograph. 

Table 5 shows the distribution of cleared submissions by class and 

characteristics of the determination. 

Table 5: Characteristics of Cleared 510(k) Submissions, Fiscal Years 2005 through

2007 

Characteristics of cleared submissions

Class II 

(percentage) 

Class III

(percentage)

Total

(percentage)

Same technological characteristics 4,052 (86) 75 (77) 4,127 (86)

New technological characteristics that 

could not affect safety or effectiveness 323 (7) 12 (12) 335 (7)

New technological characteristics that do 

not raise new types of safety or 

effectiveness questions 342 (7) 11 (11) 353 (7)

Total 4,717 (100) 98 (100) 4,815 (100)

Source: GAO analysis of FDA files. 

Note: Data are estimated for 4,815 510(k) submissions based on a sample of submissions for class II

and class III devices cleared by FDA in fiscal years 2005 through 2007. The sampling errors of the 

estimates of class II 510(k) submissions and total 510(k) submissions are within plus or minus 

5 percentage points at the 95 percent confidence level. 

More Than Half of the 

510(k) Submissions FDA 

Determined Not 

Substantially Equivalent 

Were for Devices That 

Had a New Intended Use 

or New Technological 

Characteristics 

We found that of the 248 class II and III submissions that FDA determined 

to be NSE in fiscal years 2005 through 2007, slightly more than half 

• had a new intended use,

• had a new technological characteristic that raised new types of safety or 

effectiveness questions, or 

• had a new technological characteristic that could affect safety or 

effectiveness and did not have performance data to demonstrate 

equivalence to the predicate device. 

We also found that about one in every three 510(k) submissions FDA 

determined to be NSE had the same intended use and the same 

technological characteristics as the predicate device, but FDA determined 

the submissions NSE because of a lack of performance data. An additional 

13 percent of submissions were determined NSE for other reasons, such as 

Page 26 GAO-09-190 Medical Device Premarket Review
 

not providing adequate data early in the review or not having a predicate 

device (see table 6). 

Table 6: Characteristics of 510(k) Submissions for Devices FDA Determined NSE in

Fiscal Years 2005 through 2007 

Characteristics 

Class II 

(percentage) 

Class III

(percentage)

Total

(percentage)

New intended use 15 (8) 22 (34) 37 (15)

New technological characteristics that 

raise new types of safety or effectiveness 

questions 19 (10) 22 (34) 41 (17)

New technological characteristics 

and insufficient performance data 42 (23) 7 (11) 49 (20)

Same technological characteristics, but 

insufficient performance data 88 (48) 1 (2) 89 (36)

Othera19 (10) 13 (20) 32 (13)

Total 183 (100) 65 (100) 248 (100)

Source: GAO analysis of FDA files. 

Notes: Data are estimated for 248 510(k) submissions for class II and class III devices that FDA 

determined NSE in fiscal years 2005 through 2007. The sampling errors of the estimates of class II 

510(k) submissions and total 510(k) submissions are within plus or minus 10 percentage points at the 

95 percent confidence level. 

Percentages may not add to 100 because of rounding. 

a

Other includes 510(k) submissions for devices that were required to go through the PMA process, 

devices that did not have a predicate, and those that were determined to be NSE because of a lack of

data early in the 510(k) process. 

The 510(k) process plays a major role in FDA’s oversight of medical 

devices. During fiscal years 2003 through 2007, FDA reviewed over 2,400

510(k) submissions annually and cleared about 90 percent of these 

submissions for the U.S. market. These included 228 cleared submissions 

for class III devices. In establishing device classes in 1976, Congress 

envisioned that all class III devices would eventually be required to 

undergo premarket review through the more stringent PMA process, 

which requires the manufacturer to provide evidence, which may include 

clinical data, providing reasonable assurance that the new device is safe 

and effective. However, certain preamendment class III device types may 

be reviewed through the 510(k) process until such time as FDA publishes 

regulations requiring them to go through the PMA process. In 1990 the 

SMDA directed FDA to take action on the remaining preamendment 

class III device types by reclassifying them to a lower class or requiring 

them to remain in class III and go through the PMA process, but we found 

Conclusions 

Page 27 GAO-09-190 Medical Device Premarket Review
 

that more than 14 years after FDA published its strategy and plans for 

doing so, a significant number of class III 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—still enter the 

market through the less stringent 510(k) process. 

FDA has stated that eventually all class III devices will require FDA 

approval through the PMA process and FDA officials reported that the 

agency is committed to addressing this issue, but the agency has not 

specified time frames for doing so. Without FDA action, the remaining 

preamendment class III device types—including device types that FDA 

identified in 1994 as presenting an unreasonably high risk to public 

health—may enter the U.S. market through FDA’s less stringent premarket 

notification process. 

We are recommending 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 

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. 

We received comments on a draft of this report from HHS. (See app. VI.) 

The department commented that the draft report fairly and accurately 

describes FDA’s 510(k) program and the department agreed with our 

conclusions and recommendation. 

HHS agreed with our recommendation that FDA expeditiously take steps 

to reclassify or require PMAs for each class III device type currently 

allowed to enter the market through the 510(k) process, noting that since

1994 (when FDA announced it 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, do 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 

Recommendation for 

Executive Action 

Agency Comments 

Page 28 GAO-09-190 Medical Device Premarket Review
 

to undergo premarket review through the more stringent PMA process, 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. 

The department also provided technical comments, which we 

incorporated as appropriate. 

We are sending copies of this report to the Secretary of Health and Human 

Services and other interested parties. The report is also available at no 

charge on the GAO Web site at http://www.gao.gov. 

If you or your staff have any questions about this report, please contact me 

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 report. GAO staff who made major contributions to this report are 

Marcia Crosse 

listed in appendix VII. 

Director, Health Care 

Page 29 GAO-09-190 Medical Device Premarket Review
Appendix I: Scope and Methodology Appendix I: Scope and Methodology 

To review the Food and Drug Administration’s (FDA) use of the 510(k) 

and premarket approval (PMA) processes to review class I, II, and III 

device submissions in fiscal years 2003 through 2007, we used FDA’s 

510(k) and PMA databases. These databases contain information on device

submissions,1

 including the name of the device, the FDA-assigned product 

code,2

 the status of the submission, and any FDA decisions related to the 

submission and the dates of those decisions. In both cases, we obtained

and analyzed data on submissions for which FDA made a review decision 

in fiscal years 2003 through 2007.3

 We also used FDA’s Device 

Nomenclature Management System to determine other attributes of the 

device types covered by the device submissions. 

The 510(k) submissions we analyzed included traditional and abbreviated 

510(k) submissions. We did not include special 510(k) submissions, which 

are requests for clearance of modifications to devices that have already 

been cleared through the 510(k) process (see table 7). The PMA 

submissions we analyzed included original PMA submissions and some 

supplemental PMA submissions. Specifically, we included supplemental

PMA submissions that represented requests for approval for a significant 

change in a device: panel-track supplements, which are requests for 

approval for a significant change in design, performance, or use of a 

device for which clinical data are necessary to provide a reasonable 

assurance of safety and effectiveness; and 180-day (user-fee) 

supplements, which are requests for approval for a significant change in 

components, materials, design, specification, software, color additives, or

labeling. We did not include other types of PMA supplements, such as realtime supplements, which are requests for approval for a minor change to a 

 1

In this report, we refer to both 510(k) submissions and PMA applications as device 

submissions. Because related devices can be “bundled” together in a single submission, 

one submission may include one or more devices. 

2

The FDA-assigned product code for a device is based on the relevant classification 

regulation. 

3

For the purposes of this report, review decisions include cases where FDA made a 

determination to allow or disallow marketing of a device and cases where FDA decided to

discontinue consideration for other reasons.

Page 30 GAO-09-190 Medical Device Premarket Review
Appendix I: Scope and Methodology 

device, such as a minor change in design, sterilization, software, or 

labeling.4

To assess the reliability of these data, we interviewed FDA officials 

knowledgeable about these databases, performed electronic testing for 

accuracy and completeness, and where applicable compared our results to 

aggregate information from other sources, such as published FDA reports 

and the FDA Web site. We determined that the data were sufficiently 

reliable for the purposes of this report. 

In order to examine the extent to which FDA has determined that devices 

reviewed through the 510(k) process had new intended uses or new 

technological characteristics, we used FDA’s 510(k) database to select and 

review a stratified random sample of class II and all class III 510(k) 

submission files from fiscal years 2005 through 2007. See table 7 for the 

scope of our file review.

 4

Our analysis also excluded de novo submissions. De novo submissions are for first-of-akind devices lacking a legally marketed predicate. Anyone submitting a 510(k) for a device 

type that has not been previously classified and which FDA subsequently classifies into 

class III may, within 30 days after receiving notice of such classification, request that FDA

reclassify the device under the statutory criteria for class I and class II devices. The 

de novo classification process permits FDA to establish a class I or II designation for 

devices that do not have a predicate and allow them to enter the U.S. market. See 21 U.S.C. 

§ 360c(f)(2). 

Page 31 GAO-09-190 Medical Device Premarket Review
Appendix I: Scope and Methodology 

Table 7: Scope of File Review by 510(k) Submission Type, Review Decision, and FDA Office or Center 

Characteristic of 510(k) submission

Included in file

review? Reason

Submission type

Traditional Yes Traditional 510(k) submissions are the conventional 510(k) submission

type used to clear new devices for market. Traditional submissions 

constituted the majority of 510(k) submissions made to FDA during the 

time of our review. 

Abbreviated Yes Abbreviated 510(k) submissions are a streamlined version of the 

traditional 510(k) process. In an abbreviated 510(k) submission, 

applicants use guidance documents, special controls, or performance 

standards to assess and then report on the performance of their new 

device to expedite review. 

Special No Special 510(k) submissions are submitted for a modification to a device 

that has been cleared through the 510(k) process. We excluded them 

from our review because this type of submission is only used for 

modifications to a device which has already cleared the 510(k) process.

Review decision

Substantially equivalent (SE) Yes The submissions completed the 510(k) review process and were 

cleared for market. 

Not substantially equivalent (NSE) Yes The submissions completed the 510(k) review process and were not 

cleared for market. 

Withdrawn No Withdrawn submissions did not complete the 510(k) review process. 

Deleted No Deleted submissions did not complete the 510(k) review process. 

FDA office or center 

Center for Devices and Radiological

Health, Office of Device Evaluation 

Yes This office administers the 510(k), PMA, Humanitarian Device

Exemption, and Investigational Device Exemption programs. It 

processes the majority of 510(k) submissions each year: for example, in

FY 2007, it processed 85 percent of all 510(k) submissions. 

Center for Devices and Radiological

Health, Office of In Vitro Diagnostic 

Device Evaluation and Safety

No This office oversees the regulation of devices such as in-home and 

laboratory diagnostic tests, and processes relatively few 510(k) 

submissions each year. In FY 2007, it processed 13 percent of all 

510(k) submissions. 

Center for Biologics Evaluation and 

Research 

No This office oversees devices such as those used for licensed blood 

collection and processing, and processes relatively few 510(k) 

submissions each year. In FY 2007, it processed 2 percent of all 510(k) 

submissions. 

Source: GAO.

Note: The scope of the file review also excluded de novo submissions, which are submissions for 

first-of-a-kind devices lacking a legally marketed predicate. See 21 U.S.C. § 360c(f)(2). 

All 163 class III submissions that met the inclusion criteria were included 

in the sample. The 296 class II cases included in the sample constituted a 

random sample of the 4,900 class II submissions that met the inclusion 

criteria. The class II submissions included in the sample were stratified by 

Page 32 GAO-09-190 Medical Device Premarket Review
Appendix I: Scope and Methodology 

decision, meaning that class II submissions determined not substantially 

equivalent (NSE) were oversampled so that the results could be 

generalizable to the universe of all class II submissions, to class II 

submissions determined NSE, or to class II submissions determined 

substantially equivalent (SE). The sample contained a total of 459 

submissions. See tables 8 and 9 for the number of submissions by fiscal 

year, class, and decision.

Table 8: Cases Reviewed, by Fiscal Year 

Fiscal year Count Percentage

2005 167 36

2006 141 31

2007 151 33

Total 459 100

Source: GAO.

Table 9: Cases Reviewed, by Class and SE/NSE Determination

FDA decision Class II Class III Total

SE 195 102 297

NSE 101 61 162

Total 296 163 459

Source: GAO.

We conducted our file review in June 2008. We collected data primarily 

from the FDA reviewer memo, which contained information concerning 

the steps FDA took to reach its determination of SE or NSE. This 

information included the incremental decisions FDA made concerning the 

use and technological characteristics of the new device, and in sum, 

defined the path through an FDA decision tree the reviewer took to reach 

a determination of SE or NSE. See figures 7 and 8 for detailed and 

simplified versions, respectively, of FDA’s decision tree. We recorded the 

individual decisions made in each case, and analyzed the results with 

respect to the path the FDA reviewer took to reach the final determination 

of SE or NSE. 

Page 33 GAO-09-190 Medical Device Premarket Review
Appendix I: Scope and Methodology 

Figure 7: Detailed Version of FDA’s 510(k) Decision-Making Process 

Source: GAO.

New device is compared to 

a predicate device

Are performance data

available to assess

equivalence?a

Substantially Equivalent 

(SE) 

Are performance data

available to assess

equivalence?a

Are performance data

available to assess effects of 

new characteristics?a

Does the device have the 

same indication statement?

Do differences alter the

intended effect of the 

device?

New device has new 

intended use 

Do performance data

demonstrate equivalence?

Do performance data

demonstrate equivalence?

Do performance data

demonstrate equivalence?

Not Substantially Equivalent (NSE)

New device has the same

intended use

Does the new device have 

the same technological 

characteristics?

Could the new 

characteristics affect safety 

or effectiveness?

Do the new 

technological 

characteristics raise 

new types of safety or 

effectiveness

questions?

Are the descriptive 

characteristics precise 

enough to ensure 

equivalence?

Are the descriptive 

characteristics precise 

enough to ensure 

equivalence?

Do accepted scientific 

methods exist for assessing 

effects of the new 

characteristics?

No

Yes Yes

No

Yes

Yes Yes

No

No

Yes

No

No

Yes

Yes No

Yes

No No

No Yes

Yes

No

Yes

Yes

Yes

Descriptive 

information about 

new or marketed 

device requested 

as needed 

1

2

5

5

5

1

3

4

4

3

3

4

4

Notes: Numbered boxes correspond to numbered boxes on the simplified FDA decision-making 

process in fig. 8.

a

Data may be in the 510(k), other 510(k)s, the center’s classification files, or the literature. In cases 

where FDA determines that performance data are not available, FDA requests data from the 

applicant. 

Page 34 GAO-09-190 Medical Device Premarket Review
Appendix I: Scope and Methodology 

Figure 8: Simplified Version of FDA’s 510(k) Decision-Making Process 

New device is compared 

to a predicate device

Substantially Equivalent 

(SE) 

Do descriptive or performance 

data demonstrate equivalence?

Do descriptive or 

performance data

demonstrate equivalence?

Does the new device have 

the same intended use?

Does the new device have 

the same technological 

characteristics?

Do the new technological 

characteristics raise new types

of safety or effectiveness

questions?a

Yes

Not Substantially 

Equivalent (NSE)

No

Yes

Yes

No

Yes

No

Yes

No

No

Source: GAO.

1

2

5

3

4

Notes: Numbered boxes correspond to numbered boxes on the detailed decision tree in figure 7. 

In cases where FDA determines that a new device has new technological characteristics that could 

not affect safety and effectiveness, the device may be determined SE if descriptive characteristics 

alone are precise enough to ensure equivalence. If not, FDA will look at performance data. In cases

where FDA determines that a new device has new technological characteristics that could affect 

safety and effectiveness, FDA requires performance data to demonstrate substantial equivalence. For 

cases in which descriptive or performance information is insufficient, FDA requests additional 

information. 

a

For devices with new technological characteristics, FDA first examines whether the new 

technological characteristics could affect safety or effectiveness. 

In the 10 cases where we could not determine the steps FDA took to reach

its determination during our file review, we requested additional 

information from FDA officials. Officials from the Office of Device 

Evaluation in FDA’s Center for Devices and Radiological Health reviewed

the files in question and provided us with the information we requested. 

To assess the reliability of these data, we compared our results with 

information from FDA’s 510(k) database and Device Nomenclature 

Management System. In addition, FDA officials stated that the data in the 

files were accurate and reliable and provided input in the development of 

our data collection instrument. 

Page 35 GAO-09-190 Medical Device Premarket Review
Appendix I: Scope and Methodology 

In addition to our data analysis, we reviewed relevant laws and regulations 

concerning the premarket review process. We also interviewed FDA 

officials from the FDA centers and offices that process device submissions 

(Center for Biologics Evaluation and Research, Office of Device 

Evaluation, and Office of In Vitro Diagnostic Device Evaluation and 

Safety). Finally, we interviewed representatives from professional 

associations representing device manufacturers (the Advanced Medical 

Technology Association, the ECRI Institute, the Medical Device 

Manufacturers Association, and the Medical Imaging and Technology 

Alliance) and consumer advocates (the National Research Center for 

Women & Families and Public Citizen). 

We conducted this performance audit from March 2008 to January 2009 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. 

Page 36 GAO-09-190 Medical Device Premarket Review
Appendix II: Third-Party Review of 510(k)

Submissions 

Page 37 GAO-09-190

Appendix II: Third-Party Review of 510(k) 

Submissions 

The FDA Modernization Act of 1997 directed FDA to accredit third parties 

(called accredited persons) in the private sector to conduct the initial 

review of 510(k) submissions for low- to moderate-risk devices.1

 Under 

FDA’s Accredited Persons Program, device manufacturers may contract 

with accredited organizations (third parties)2

 to review certain 510(k) 

submissions for a negotiated fee.

3

 The third party uses the same statutory 

and regulatory criteria as FDA to determine substantial equivalence, 

documents its review and recommendation, and forwards the 510(k) 

submission and documentation to FDA’s Center for Devices and 

Radiological Health. At the center, a third-party 510(k) submission is 

assessed by an FDA supervisor, who may accept or change the substantial

equivalence recommendation of the third party. After completing the 

supervisory assessment, FDA issues a letter to the 510(k) applicant via the 

third-party reviewer with a final determination on the 510(k) submission. 

During the third-party review, the FDA supervisor can request additional 

information from the third party and the third party can request additional 

information from the 510(k) applicant. 

FDA expanded the program to include more than 670 class I and class II 

device types to be eligible for 510(k) review by a third party.4

 These 

include device types for diagnostic ultrasound systems, computed 

tomography X-ray systems, and surgical lasers. However, not all of the 

accredited third parties are authorized to review all device types eligible

for third-party review. For example, in October 2008 FDA’s Web site listed

7 of 11 accredited third parties as authorized to review 510(k) submissions 

for hearing aids. 

 1

Pub. L. No. 105-115, § 210, 111 Stat. 2296, 2342 (1997). 

2

As of August 6, 2008, FDA listed 11 accredited third parties that can conduct third-party

reviews of 510(k) submissions: (1) British Standards Institution; (2) Center for 

Measurement Standards of Industrial; (3) Cheiroon BV; (4) Citech; (5) Intertek Testing 

Services; (6) Kema Quality B.V.; (7) Niom-Scandanavian Institute of Dental Materials; 

(8) Regulatory Technology Services, LLC; (9) TUV Rheinland of North America, Inc.; 

(10) TUV SUD America, Inc.; and (11) Underwriters Laboratories, Inc. 

3

FDA does not maintain data on the amount of these fees, which are negotiated between 

the 510(k) submitter and the third-party reviewer. However, FDA officials estimate the fee 

to generally be in the $5,000 to $10,000 range.

4

FDA initially identified 154 device types that were eligible for third-party review. In March 

2001, FDA expanded the program to allow third parties to review 510(k) submissions for 

many class II device types that were not previously eligible. 

Medical Device Premarket Review
Appendix II: Third-Party Review of 510(k)

Submissions 

Device types that are not eligible for third-party review include all class III 

devices; class II devices intended to be permanently implantable, life 

sustaining, or life supporting; and class II devices requiring clinical data to

support their 510(k) clearance.5

 During our review of FDA’s 510(k) 

database, we found three instances of 510(k) submissions in which class II 

devices that were life sustaining were cleared for market through the 

third-party review program during fiscal years 2003 through 2007. FDA 

officials explained that about five life-sustaining, class II device types, 

hemodialysis devices, had inadvertently been added to the list of devices 

eligible for third-party review when the list was expanded in 2001, and that 

in May 2003, FDA removed the life-sustaining class II device types from 

the list of devices eligible for third-party review on FDA’s Web site. The 

FDA officials said that while the three 510(k) submissions for class II lifesustaining device submissions had been submitted through the third-party 

review program, FDA also conducted its own review of the three 510(k) 

submissions before they were cleared for marketing. 

During fiscal years 2003 through 2007, FDA reviewed and made final 

determinations on 1,082 third-party 510(k) submissions (see table 10). 

According to FDA, the number of third-party submissions increased as the 

result of (1) increased familiarity with the third-party review program 

among potential applicants, (2) the increase in the number of device types 

eligible for the program, and (3) less financial disincentives to use the 

third-party review program as FDA instituted device user fees.

6

 An FDA 

official familiar with the program stated that the third-party review 

program may be more attractive to device manufacturers because thirdparty review 510(k) submissions are processed faster than traditional 

510(k) submissions. The official noted, however, that as FDA’s review of 

traditional 510(k) submissions becomes more efficient, the advantages of

 5

21 U.S.C. § 360m(a)(3)(A). In addition, in February 2001, FDA issued guidance stating that 

third parties may not review 510(k) submissions that require multiple FDA centers to

review the device—for example, for drug-device combination products—or if a center

other than the Center for Devices and Radiological Health, for example, the Center for 

Biologics Evaluation and Research, has the primary responsibility for the 510(k) review.

6

FDA user fees for FDA review of medical device applications took effect at the beginning 

of fiscal year 2003. 

Page 38 GAO-09-190 Medical Device Premarket Review
Appendix II: Third-Party Review of 510(k)

Submissions 

the third-party review program in terms of timeliness may diminish, which 

could lead to fewer third-party review 510(k) submissions.7

Table 10: Third-Party Review 510(k) Submissions with FDA Decisions, Fiscal Years 

2003 through 2007

FDA decision

Fiscal year SE (percentage) NSE (percentage) Total (percentage)

2003 157 (15) 2 (10) 159 (15)

2004 227 (21) 9 (43) 236 (22)

2005 226 (21) 3 (14) 229 (21)

2006 242 (23) 6 (29) 248 (23)

2007 209 (20) 1 (5) 210 (19)

Total 1,061 (100) 21 (100) 1,082 (100)

Source: GAO analysis of FDA data. 

Note: Percentages may not sum to 100 because of rounding. 

Table 11 shows the third-party review 510(k) submissions by medical 

specialty. 

 7

According to FDA, in fiscal year 2005 the difference in average review times between 

510(k) submissions reviewed by third parties and 510(k) submissions reviewed entirely by

FDA was 13 days, versus 45 days in fiscal year 2000. 

Page 39 GAO-09-190 Medical Device Premarket Review
Appendix II: Third-Party Review of 510(k)

Submissions 

Table 11: Third-Party Review 510(k) Submissions by Medical Specialty, Fiscal Years 

2003 through 2007

Medical specialty Frequency Percentage

Radiology 411 38.7

General and plastic surgery 120 11.3

Cardiovascular 116 10.9

General hospital 98 9.2

Dental 52 4.9

Gastroenterology and urology 49 4.6

Anesthesiology 45 4.2

Neurology 45 4.2

Physical medicine 43 4.1

Ophthalmic 25 2.4

Obstetrics and gynecology 22 2.1

Clinical chemistry 13 1.2

Ear, nose, and throat 7 0.7

Clinical toxicology 4 0.4

Microbiology 4 0.4

Hematology 3 0.3

Orthopedic 3 0.3

Immunology 1 0.1

Total 1,061 100

Source: GAO analysis of FDA data. 

Note: Percentages may not sum to 100 because of rounding. 

Page 40 GAO-09-190 Medical Device Premarket Review
Appendix III: FDA’s Implementation of Safe Appendix III: FDAMedical Devices Act Provisions ’s Implementation of Safe 

Medical Devices Act Provisions 

The Safe Medical Devices Act of 1990 (SMDA) amended the definition of 

class II devices1

 and required FDA, for each preamendment class III device 

type and before December 1, 1995, to (1) order manufacturers to submit 

information on safety and effectiveness to FDA and (2) publish proposed 

and final regulations to reclassify each device type into class II or class I or 

to require it to remain in class III. For those devices for which FDA 

published a regulation requiring the device to remain in class III, the 

SMDA further directed FDA to, as promptly as reasonably achievable but 

not later than 12 months after the effective date of the regulation requiring 

the device to remain in class III, establish a schedule for the promulgation 

of regulations requiring the submission of PMAs. 

In an April 19, 1994, memorandum from the Acting Director of the FDA 

Center for Devices and Radiological Health’s Office of Device Evaluation, 

FDA outlined its strategy for implementation of the SMDA. Specifically, 

FDA grouped 117 preamendment class III device types for which FDA had

not yet initiated any action to require the submission of PMAs into three 

groups and prioritized the devices to facilitate the SMDA activities. (See 

table 12.) The agency’s proposed strategy established a plan for beginning 

to address the class III device types that were continuing to be reviewed 

through the 510(k) process, but did not establish completion dates for 

doing so. 

 1

Before enactment of the SMDA, class II devices were defined as devices for which general 

controls alone were insufficient to provide reasonable assurance of safety and 

effectiveness, but for which sufficient information existed to establish a performance

standard to provide such assurance. Under the SMDA, the definition was revised to include 

those devices for which sufficient information existed to establish special controls to

provide such assurance. In addition to performance standards, special controls include

postmarket surveillance, patient registries, guidelines and recommendations, and other 

appropriate actions as determined by FDA. The SMDA also stated that for class II devices 

that purported or represented to be used for supporting or sustaining human life, FDA was

required to examine and identify the necessary special controls and describe how they 

would provide adequate assurance of safety and effectiveness. 

Page 41 GAO-09-190 Medical Device Premarket Review
Appendix III: FDA’s Implementation of Safe 

Medical Devices Act Provisions

Table 12: FDA Groupings and Time Frames for Implementation of SMDA Provisions for Class III Device Types in 1994 and 

Status as of October 2008 

Group 3 (device types designated high priority) 

Number of device types 15 

Description Group 3 contains devices that were not considered candidates for reclassification and that

FDA believed were in commercial distribution and would require submission of PMAs in 

the near future. 

The high-priority subgroup of group 3 contains devices FDA determined presented an 

unreasonably high risk to public health because significant issues of safety, effectiveness, 

or both were not being resolved or, to the best of FDA’s knowledge, had little probability of

being resolved.

Examples Certain types of hip joints and shoulder joints, ultrasound and muscle stimulator. 

Planned schedule FDA planned to publish proposed rules related to these 15 device types by 1996. In its 

1994 strategy memorandum, FDA noted that the timetable for publication of each final 

rule would be based upon specific data needs, comments received, and the existence, if 

any, of any petitions to reclassify the devices that FDA needed to review. 

Status as of October 2008 Of the 15 device types designated high priority in group 3, 5 were reclassified, 6 now 

require PMAs, and 4 may still be cleared through the 510(k) process. 

Group 3 (other device types) 

Number of device types 27 

Description Group 3 contains devices that were not considered candidates for reclassification and that

FDA believed were in commercial distribution and would require submission of PMAs in 

the near future. 

The devices in group 3 that were not designated high priority were not considered

candidates for reclassification, but FDA planned to assess whether these devices should

be moved to group 2. FDA stated that the continued marketing of these group 3 devices 

did not present as great a risk to the public health, in light of FDA’s knowledge and 

experience with the devices, as the device types designated high priority. 

Examples External pacemaker pulse generator, stairclimbing wheelchair. 

Planned schedule FDA planned to pursue the same course of evaluation and prioritization as used for group

2 device types. 

Status as of October 2008 Of the 27 other device types in group 3 that were not designated high priority, 13 were 

reclassified, 7 now require PMAs, and 7 may still be cleared through the 510(k) process. 

Group 2

Number of device types 31 

Description Group 2 contains devices that FDA believed had a high potential for reclassification into 

class II and for which existing questions of safety, effectiveness, or both had been or 

could be answered by information already obtained or being obtained by manufacturers. 

According to FDA, the SMDA-modified definition of class II devices together with 

increased experience with these device types might provide grounds for reclassification of

group 2 devices. 

Examples Tweezer-type epilator, cardiovascular permanent pacemaker electrodes, implanted blood 

access device.

Page 42 GAO-09-190 Medical Device Premarket Review
Appendix III: FDA’s Implementation of Safe 

Medical Devices Act Provisions

Group 3 (device types designated high priority) 

Planned schedule FDA planned to issue an order requiring manufacturers to submit all safety and 

effectiveness information available or known to them, including adverse information, for all 

group 2 device types, to complete a review and evaluation of this safety and effectiveness

information, and to proceed with rule making to reclassify these device types or retain 

them in class III by 1998. The 1994 memorandum did not specify any dates for publication 

of final regulations reclassifying devices or requiring them to remain in class III. 

Status as of October 2008 Of the 31 device types in group 2, 23 were reclassified, 1 now requires a PMA, and 7 may

still be cleared through the 510(k) process (this includes 1 case in which the device type 

was reclassified for some purposes but remains class III for others). 

Group 1

Number of device types 44 

Description Group 1 contains device types that FDA identified as having fallen into disuse or limited

use. FDA determined that these device types raise significant questions of safety, 

effectiveness, or both but are rarely in current use. FDA believed that rule making 

requiring PMAs for these device types would be unlikely to result in viable PMAs or 

reclassification petitions. 

Examples Catheter balloon repair kit; certain types of hip joints, finger joints, and shoulder joints. 

Planned schedule FDA planned to publish one proposed regulation in 1994 requiring PMAs for all group 1 

devices. The 1994 memorandum did not specify any dates for publication of final 

regulations. 

Status as of October 2008 Of the 44 device types in group 1, 4 were reclassified, 39 now require PMAs, and 1 may 

still be cleared through the 510(k) process. 

All groups

Number of device types 117 

Status as of October 2008 Of the 117 device types contained in FDA’s strategy document, 45 have been reclassified, 

53 now require PMAs, and 19 may still be cleared through the 510(k) process. 

Source: GAO.

Note: In addition, the 1994 memorandum listed additional device types for which some action had 

been taken toward reclassification or requiring PMA submissions. For example, the memorandum 

listed device types, including endosseous (dental) implants, with reclassification petitions pending. 

As of October 2008, FDA had reclassified 45 device types and published 

regulations requiring PMAs for 53 device types. Therefore, of the 117 

preamendment class III device types covered by FDA’s strategy, 19 device 

types remain in class III and may be cleared through the 510(k) process.2

Four of those 19 device types are types that FDA had placed in group 3 

and designated high priority—that is, they are device types that FDA had 

determined to present an unreasonably high risk to public health because 

significant issues of safety or effectiveness were not being resolved or, to

the best of FDA’s knowledge, had little probability of being resolved. 

 2

See app. IV for information on class III device types that were cleared through the 510(k) 

process in fiscal years 2003 through 2007. 

Page 43 GAO-09-190 Medical Device Premarket Review
Appendix IV: Additional Information on 

510(k) Submissions for Class III Devices Appendix IV Reviewed by FDA : Additional Information on 

510(k) Submissions for Class III Devices 

Reviewed by FDA 

This appendix summarizes the results from GAO analysis of FDA’s data for 

class III 510(k) submissions with FDA review decisions in fiscal years 2003 

through 2007. The following tables show FDA’s final decisions for 

submissions for class III devices for each fiscal year through the 510(k) 

process (table 13); the primary medical specialties for submissions for 

class III devices cleared through the 510(k) process (table 14); and a 

detailed list of all device types covered by the class III devices cleared 

through the 510(k) process, including the status of these device types as of

October 2008 (table 15).

Table 13: FDA Review Decisions for Class III 510(k) Submissions by Fiscal Year, 

Fiscal Years 2003 through 2007 

FDA Decision

Fiscal Year 

SE

(percentage

of row)

NSE

(percentage

of row)

Other

a

(percentage

of row)

Total

(percentage

of row)

2003 58 (80) 12 (16) 3 (4) 73 (100)

2004 68 (80) 13 (15) 4 (5) 85 (100)

2005 31 (52) 27 (45) 2 (3) 60 (100)

2006 32 (50) 31 (48) 1 (2) 64 (100)

2007 39 (65) 17 (28) 4 (7) 60 (100)

Total 228 (67) 100 (29) 14 (4) 342 (100)

Source: GAO analysis of FDA data. 

a

Other decisions include submissions that were withdrawn, exempted by regulation, not responsive to 

FDA’s requests within a specified time frame, forwarded to another FDA center or office, duplicates, 

determined not to be a device, or not actively regulated by FDA. 

Page 44 GAO-09-190 Medical Device Premarket Review
Appendix IV: Additional Information on 

510(k) Submissions for Class III Devices 

Reviewed by FDA 

Table 14: Primary Medical Specialties of Class III 510(k) Submissions Cleared in 

Fiscal Years 2003 through 2007 

Medical specialty Frequency Percentage

Cardiovascular 64 28

Orthopedic 54 24

Gastroenterology and urology 36 16

Dental 31 14

Physical medicine 19 8

Neurology 14 6

Microbiology 7 3

General and plastic surgery 2 1

Obstetrics and gynecology 1 1

Total 228 100

Source: GAO analysis of FDA data. 

Note: Totals may not sum to 100 because of rounding. 

Page 45 GAO-09-190 Medical Device Premarket Review
Appendix IV: Additional Information on 

510(k) Submissions for Class III Devices 

Reviewed by FDA 

Table 15: Device Types with Class III 510(k) Submissions Cleared in Fiscal Years 2003 through 2007 and Their Status as of 

October 2008

Device type

(regulation number)

Number of submissions

cleared in FYs 2003-2007 Actions taken as of October 2008 

Device types included in group 3 and designated high priority in FDA’s 1994 strategya

Iontophoresis deviceb

(21 C.F.R. § 890.5525(b)) 

18 FDA published a notice of intent to reclassify this device type in 

2000. FDA has not issued a regulation reclassifying or requiring 

PMA submissions for this device type. It remains a class III type 

that may be cleared through the 510(k) process. 

Hip joint metal/metal 

semiconstrained, with an 

uncemented acetabular component, 

prosthesis 

(21 C.F.R. § 888.3330) 

18 FDA rejected one petition to reclassify this device type in 2002 

and received another classification petition in 2005. According to 

FDA officials, the agency is reviewing the reclassification petition 

that it received in 2005. While it is doing so, this remains a class 

III device type that may be cleared through the 510(k) process. 

Hip joint metal/metal semiconstrained, with a cemented 

acetabular component, prosthesis 

(21 C.F.R. § 888.3320) 

2 FDA rejected one petition to reclassify this device type in 2002 

and received another classification petition in 2005. According to 

FDA officials, the agency is reviewing the petition that it received 

in 2005. While it is doing so, this remains a class III device type 

that may be cleared through the 510(k) process. 

Shortwave diathermyc 

(21 C.F.R. § 890.5290) 

1 FDA requested that manufacturers submit safety and 

effectiveness information by August 14, 1997. FDA has not 

issued a regulation reclassifying or requiring PMA submissions 

for this device type. It remains a class III type that may be 

cleared through the 510(k) process. 

Device types included in group 3 (but not designated high priority) in FDA’s 1994 strategya

Neurovascular embolization deviced

(21 C.F.R. § 882.5950) 

11 FDA reclassified this device type to class II effective January 28, 

2005. 

External counter-pulsating device 

(21 C.F.R. § 870.5225) 

9 FDA requested that manufacturers submit safety and 

effectiveness information by February 14, 1997. FDA has not 

issued a regulation reclassifying or requiring PMA submissions 

for this device type. It remains a class III type that may be 

cleared through the 510(k) process. 

Arrythmia detector and alarm

(21 C.F.R. § 870.1025) 

7 FDA reclassified this device type to class II effective November 

28, 2003. 

Vascular embolization deviced

(21 C.F.R. § 870.3300) 

4 FDA reclassified this device type to class II effective January 28, 

2005. 

Intra-aortic balloon and control 

system 

(21 C.F.R. § 870.3535) 

2 FDA requested that manufacturers submit safety and 

effectiveness information by August 14, 1997. FDA has not 

issued a regulation reclassifying or requiring PMA submissions 

for this device type. It remains a class III type that may be 

cleared through the 510(k) process. 

Sorbent hemoperfusion system 

(21 C.F.R. § 876.5870) 

1 FDA requested that manufacturers submit safety and 

effectiveness information by February 14, 1998. FDA has not 

issued a regulation reclassifying or requiring PMA submissions 

for this device type. It remains a class III type that may be 

cleared through the 510(k) process. 

Page 46 GAO-09-190 Medical Device Premarket Review
Appendix IV: Additional Information on 

510(k) Submissions for Class III Devices 

Reviewed by FDA 

Device type

(regulation number)

Number of submissions

cleared in FYs 2003-2007 Actions taken as of October 2008 

External pacemaker pulse generator

(21 C.F.R. § 870.3600) 

1 FDA that requested manufacturers submit safety and 

effectiveness information by August 14, 1997. FDA has not 

issued a regulation reclassifying or requiring PMA submissions 

for this device type. It remains a class III type that may be 

cleared through the 510(k) process. 

Device types included in group 2 in FDA’s 1994 strategya

Blood access device (implanted) 

(21 C.F.R. § 876.5540(b)(1))

35 FDA requested that manufacturers submit safety and 

effectiveness information by August 14, 1998. FDA has not 

issued a regulation reclassifying or requiring PMA submissions 

for this device type. It remains a class III type that may be 

cleared through the 510(k) process. 

Herpes simplex virus serological 

assaysd

(21 C.F.R. § 866.3305) 

7 FDA reclassified this device type to class II for type 1 and/or type 

2 serological assays effective May 3, 2007; all other assays

remain class III and may be cleared through the 510(k) process. 

According to FDA, the seven class III 510(k) submissions for 

herpes simplex virus serological assays cleared in fiscal years 

2003 through 2007 were for type 1 and/or type 2 serological 

assays. 

External cardiac compressor

(21 C.F.R. § 870.5200) 

4 FDA requested that manufacturers submit safety and 

effectiveness information by August 14, 1998. FDA has not 

issued a regulation reclassifying or requiring PMA submissions 

for this device type. It remains a class III type that may be 

cleared through the 510(k) process. 

Topical oxygen chamber for 

extremities 

(21 C.F.R. § 878.5650) 

2 FDA requested that manufacturers submit safety and 

effectiveness information by August 14, 1997; FDA published a 

proposal to reclassify in 2006. FDA has not issued a regulation 

reclassifying or requiring PMA submissions for this device type. It 

remains a class III type that may be cleared through the 510(k) 

process. 

Cardiovascular pacemaker 

electrodes (permanent) 

(21 C.F.R. § 870.3680) 

1 FDA requested that manufacturers submit safety and 

effectiveness information by August 14, 1997. FDA has not 

issued a regulation reclassifying or requiring PMA submissions 

for this device type. It remains a class III type that may be 

cleared through the 510(k) process. 

Other

e

Pedicle screw spinal systemf 

(21 C.F.R. § 888.3070(b)(2))

34 In 2001, FDA stated that it intended to initiate the call for PMAs 

for the device when intended for certain uses in a future Federal

Register notice. FDA has not issued a regulation reclassifying or 

requiring PMA submissions for this device type. It remains a 

class III type that may be cleared through the 510(k) process. 

Automated external defibrillator 

(21 C.F.R. § 870.5310) 

30 In 2003, FDA began to regulate automated external defibrillators 

separately from arrhythmia detectors and alarms; at that time, the 

agency published a notice of intent to initiate a proceeding to 

reclassify. FDA has not issued a regulation reclassifying or 

requiring PMA submissions for this device type. It remains a 

class III type that may be cleared through the 510(k) process. 

Page 47 GAO-09-190 Medical Device Premarket Review
Appendix IV: Additional Information on 

510(k) Submissions for Class III Devices 

Reviewed by FDA 

Device type

(regulation number)

Number of submissions

cleared in FYs 2003-2007 Actions taken as of October 2008 

Endosseous dental implant (blade 

form) 

(21 C.F.R. § 872.3640(b)(2))

26 FDA reclassified this device type to class II for root-form 

endosseous dental implants effective June 11, 2004; blade-form 

endosseous dental implants remain class III and may be cleared 

through the 510(k) process. 

Endosseous dental implant 

abutment 

(21 C.F.R. § 872.3630) 

4 FDA reclassified this device type to class II effective June 11,

2004. 

Nonroller-type cardiopulmonary 

bypass blood pump 

(21 C.F.R. § 870.4360) 

5 FDA had published a proposal to reclassify the device in 1993 

and withdrew that proposal in 2004. FDA has not issued a 

regulation reclassifying or requiring PMA submissions for this

device type. It remains a class III type that may be cleared 

through the 510(k) process. 

Cranial electrotherapy stimulator 

(21 C.F.R. § 882.5800) 

3 FDA had required PMA submissions for this device type in 1995 

but revoked that regulation in 1997. FDA requested safety and 

effectiveness information from manufacturers in 1997. FDA has 

not issued a regulation reclassifying or requiring PMA 

submissions for this device type. It remains a class III type that 

may be cleared through the 510(k) process. 

Mandibular condyle prosthesis

(temporary)g 

(21 C.F.R. § 872.3960) 

1 FDA amended the regulation in 1998 stating that no effective 

date had been established for the submission of PMAs for the 

implanted version of the device used for temporary 

reconstruction. In the applicable Federal Register notice, FDA 

added that at a later date, it would propose reclassifying from

class III to class II the generic type of temporary mandibular

condyle prosthesis intended for temporary reconstruction 

following surgical ablation of malignant and benign tumors. FDA 

has not issued a regulation reclassifying or requiring PMA 

submissions for this device type. It remains a class III type that 

may be cleared through the 510(k) process. 

Pericardial patch 2 According to agency officials, FDA is in the process of 

determining how to address the situation under which FDA 

cleared two submissions for this type of class III device through 

the 510(k) process). 

Source: GAO.

Notes: No submissions with device types included in group 1 of FDA’s 1994 strategy were cleared in

fiscal years 2003 through 2007. Generally, the name of the device type is the title of the relevant 

provision in the 2008 edition of title 21 of the Code of Federal Regulations. 

a

For a detailed description of the device types covered by FDA’s 1994 strategy, see app. III. 

b

For uses other than (1) the diagnosis of cystic fibrosis or (2) those indicated on the label of the drug

used with the device if the label includes adequate directions for the device’s use with the drug. 

c

For uses other than (1) the treatment of malignancies or (2) the generation of deep heat within body 

tissues to treat conditions such as pain, muscle spasms, and joint contractures. 

d

During the period of our review, FDA renamed these devices: the neurovascular embolization device, 

vascular embolization device, and herpes simplex virus serological assays were previously know as

the artificial embolization device, arterial embolization device, and herpes simplex virus serological

reagents, respectively. 

Page 48 GAO-09-190 Medical Device Premarket Review
Appendix IV: Additional Information on 

510(k) Submissions for Class III Devices 

Reviewed by FDA 

e

Other includes device types for which FDA had already taken some action by 1994 (for example, 

FDA indicated that it had reclassification petitions pending for some device types in 1994) as well as 

new device types that FDA established after 1994 (for example, FDA added a regulation for a subset 

of one device type). 

f

When intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, 

and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and 

spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or 

degenerative spondylolisthesis with objective evidence of a neurologic impairment. 

g

In 1998 FDA issued a regulation requiring PMAs for mandibular condyle prostheses intended for 

permanent reconstruction. 

Page 49 GAO-09-190 Medical Device Premarket Review
Appendix V: FDA’s 510(k) Decision-Making

Process 

Page 50 GAO-09-190

Appendix V: FDA’s 510(k) Decision-Making 

Process 

This appendix presents the additional information from GAO analysis of 

FDA’s 510(k) submission files for which FDA reached a determination of 

SE or NSE in fiscal years 2005 through 2007. The following figures show 

FDA’s detailed decision-making process for class II and class III 

submissions (fig. 9); the decision-making process for class II devices alone 

(fig. 10); and the decision-making process for class III devices alone 

(fig. 11). 

Medical Device Premarket Review
Appendix V: FDA’s 510(k) Decision-Making

Process 

Figure 9: Projected Percentages of 510(k) Submissions for Class II and Class III Devices in Fiscal Years 2005 through 2007 

Reaching Each Point in FDA’s Detailed Decision-Making Process 

New device is compared to 

a predicate device

Are performance data

available to assess

equivalence?a

Substantially Equivalent 

(SE) 

95.1%

Are performance data

available to assess

equivalence?a

Are performance data

available to assess effects of 

the new characteristics?a

Does the device have the 

same indication statement?

Do differences alter the

intended effect of the 

device?

New device has new 

intended use 

Do performance data

demonstrate equivalence?

Do performance data

demonstrate equivalence?

Do performance data

demonstrate equivalence?

Not Substantially Equivalent (NSE)b 

4.9%

New device has the same

intended use

Does the new device have 

the same technological 

characteristics?

Could the new 

characteristics affect safety 

or effectiveness?

Do the new 

technological 

characteristics raise 

new types of safety or 

effectiveness

questions?

Are the descriptive 

characteristics precise 

enough to ensure 

equivalence?

Are the descriptive 

characteristics precise 

enough to ensure 

equivalence?

Do accepted scientific 

methods exist for assessing 

effects of the new 

characteristics?

35.2% No

2.4% Yes 48.0% Yes

1.7% No

35.2% Yes

4.4% Yes 8.1% Yes

15.4%

No

12.3%

No

0.5%

Yes

0%

No

0.2%

No

33.5% Yes

87.1% Yes 11.5% No

98.6%

83.2% Yes

6.8% No 8.1% No

4.4% No 8.1% Yes

4.2% Yes

1.1% No

0.7%

Yes

0.7%

Yes

7.0%

8.6%

Yes

Descriptive 

information about 

new or marketed 

device requested 

as needed 

Source: GAO analysis of FDA files.

n = 5,063

Note: The sampling errors of the estimated percentages of 510(k) submissions reaching SE or NSE 

in FDA’s decision-making process are within plus or minus 1 percentage point at the 95 percent 

confidence level.

a

Performance data may be contained in the 510(k) submission, other 510(k) submissions, the center’s 

classification files, or academic literature. In cases where FDA determines that performance data are 

not available, FDA requests data from the applicant.

b

In 0.6 percent of the 5,063 cases, FDA made a determination of NSE, but the determination path is 

not represented in this flowchart. Reasons that these cases were found NSE include: the applicant 

failing to respond to an FDA data request and a PMA already being required for the device type. 

Page 51 GAO-09-190 Medical Device Premarket Review
Appendix V: FDA’s 510(k) Decision-Making

Process 

Figure 10: Projected Percentages of 510(k) Submissions for Class II Devices in

Fiscal Years 2005 through 2007 Reaching Each Point in FDA’s Decision-Making 

Process 

New device is compared 

to a predicate device

Substantially Equivalent 

(SE) 

Do descriptive or performance 

data demonstrate equivalence?

Do descriptive or 

performance data

demonstrate equivalence?

Does the new device have 

the same intended use?

Does the new device have 

the same technological 

characteristics?

Do the new technological 

characteristics raise new types

of safety or effectiveness

questions?a

82.7% Yes

Not Substantially 

Equivalent (NSE)

3.7%b 96.3%

14.9%

No

n = 4,900

99.3% Yes

84.5% Yes

14.7% No

13.6% Yes

0.3%

No

0.1%

Yes

1.2%

No

1.8%

No

Source: GAO analysis of FDA files.

Notes: In cases where FDA determines that a new device has new technological characteristics that 

could not affect safety and effectiveness, the device may be determined SE if descriptive 

characteristics alone are precise enough to ensure equivalence. In cases where FDA determines that

a new device has new technological characteristics that could affect safety and effectiveness, FDA 

requires performance data to demonstrate substantial equivalence. For cases in which descriptive or 

performance information is insufficient, FDA requests additional information. 

The sampling errors of the estimated percentages of 510(k) submissions for class II devices reaching

SE or NSE in FDA’s decision-making process are within plus or minus 1 percentage point at the 

95 percent confidence level. 

a

For devices with new technological characteristics, FDA first examines whether the new 

technological characteristics could affect safety or effectiveness. 

b

In 0.4 percent of the 4,900 class II cases, FDA made a determination of NSE, but the determination 

path is not represented in this flowchart. Reasons that these cases were found NSE include the 

applicant failing to respond to an FDA data request and a PMA already being required for the device 

type. 

Page 52 GAO-09-190 Medical Device Premarket Review
Appendix V: FDA’s 510(k) Decision-Making

Process 

Figure 11: Percentages of 510(k) Submissions for Class III Devices in Fiscal Years 

2005 through 2007 Reaching Each Point in FDA’s Decision-Making Process 

New device is compared 

to a predicate device

Substantially Equivalent 

(SE) 

Do descriptive or performance 

data demonstrate equivalence?

Do descriptive or 

performance data

demonstrate equivalence?

Does the new device have 

the same intended use?

Does the new device have 

the same technological 

characteristics?

Do the new technological 

characteristics raise new types

of safety or effectiveness

questions?a

46.0% Yes

Not Substantially 

Equivalent (NSE)

39.9%b 60.1%

31.9%

No

n = 163

78.5% Yes

46.6% Yes

19.0% No

14.1% Yes

13.5%

No

12.9%

Yes

4.9%

No

0.6%

No

Source: GAO analysis of FDA files.

Notes: In cases where FDA determines that a new device has new technological characteristics that 

could not affect safety and effectiveness, the device may be determined SE if descriptive 

characteristics alone are precise enough to ensure equivalence. In cases where FDA determines that

a new device has new technological characteristics that could affect safety and effectiveness, FDA 

requires performance data to demonstrate substantial equivalence. For cases in which descriptive or 

performance information is insufficient, FDA requests additional information. 

Totals may not sum to 100 because of rounding. 

a

For devices with new technological characteristics, FDA first examines whether the new 

technological characteristics could affect safety or effectiveness. 

b

In 7.9 percent of the 163 class III cases, FDA made a determination of NSE, but the determination 

path is not represented in this flowchart. Reasons that these cases were found NSE include: the 

applicant failing to respond to an FDA data request and a PMA already being required for the device 

type. 

Page 53 GAO-09-190 Medical Device Premarket Review
Appendix VI: Comments from the Department Appendix VI: Comments from the of Health and Human Services 

Department of Health and Human Services 

Page 54 GAO-09-190 Medical Device Premarket Review
Appendix VI: Comments from the Department 

of Health and Human Services 

Page 55 GAO-09-190 Medical Device Premarket Review
Appendix VII: 

A

GAO Contact and Staff 

cknowledgments 

Page 56 GAO-09-190

Appendix VII: GAO Contact and Staff 

Acknowledgments 

GAO Contact Marcia Crosse, (202) 512-7114 or crossem@gao.gov

In addition to the contact named above, Kim Yamane, Assistant Director; 

Susannah Bloch; Matt Byer; Sean DeBlieck; Linda Galib; Julian Klazkin; 

and Dan Ries made key contributions to this report. 

Acknowledgments 

Medical Device Premarket Review
Related GAO Products Related GAO Products 

Medical Devices: FDA Faces Challenges in Conducting Inspections of 

Foreign Manufacturing Establishments. 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. GAO-08-147. Washington, D.C.: January 31, 2008. 

Medical Devices: Challenges for FDA in Conducting Manufacturer 

Inspections. GAO-08-428T. Washington, D.C.: January 29, 2008. 

Medical Devices: FDA’s Approval of Four Temporomandibular Joint 

Implants. GAO-07-996. Washington, D.C.: September 17, 2007. 

Medical Devices: Status of FDA’s Program for Inspections by Accredited

Organizations. GAO-07-157. Washington, D.C.: January 5, 2007. 

Food and Drug Administration: Limited Available Data Indicate That 

FDA Has Been Meeting Some Goals for Review of Medical Device 

Applications. GAO-05-1042. Washington, D.C.: September 30, 2005. 

Food and Drug Administration: Data to Measure the Timeliness of 

Reviews of Medical Device Applications Are Limited. GAO-04-1022. 

Washington, D.C.: August 30, 2004. 

(290740) Page 57 GAO-09-190 Medical Device Premarket Review
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Ralph Dawn, Managing Director, dawnr@gao.gov, (202) 512-4400 

U.S. Government Accountability Office, 441 G Street NW, Room 7125 

Washington, DC 20548 

Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800 

U.S. Government Accountability Office, 441 G Street NW, Room 7149 

Washington, DC 20548 

Obtaining Copies of 

GAO Reports and 

Testimony

Order by Phone 

To Report Fraud,

Waste, and Abuse in 

Federal Programs 

Congressional 

Relations 

Public Affairs