Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process
Released: 2009-01-15T00:00:00

Letter

Background

The Medical Device Amendments of 1976 established three classes of medical devices. Under current law, these three device classes are defined as follows: 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 specific FDA guidelines, if general controls alone are insufficient to provide reasonable assurance of the device’s safety and effectiveness.

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.

Devices Exempt from FDA Premarket Review

Under federal regulations, many types of devices are exempt from FDA premarket review. Although FDA does not track the number of devices that are actually sold or marketed in the United States, manufacturers are required to register with FDA and provide a list of devices intended for commercial distribution, including device types that are exempt from premarket review. As shown in figure 1, about 67 percent of the more than 50,000 separate devices that manufacturers listed with FDA during fiscal years 2003 through 2007 were exempt from premarket review. Of the exempt devices that manufacturers listed with FDA, about 95 percent were class I devices, for example reading glasses and forceps. About 5 percent were class II devices, for example wheeled stretchers and mercury thermometers.

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. 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.

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 required or (2) reclassified the device type into class I or class II.

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.

By the late 1980s, FDA had not acted to require PMAs for many preamendment class III device types. 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; 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.

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.”

In May 1994, FDA published a notice in the Federal Register announcing a strategy for implementation of the SMDA. 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.

FDA’s 510(k) Review Process

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

FDA reviews each 510(k) submission to determine whether the device in question is SE or NSE to a predicate device. 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.

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

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.

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

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.

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

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 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.

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.

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. 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.)

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 not yet issued regulations either requiring PMA submissions or reclassifying them. These 228 510(k) submissions involved 24 device types (see table 4). 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.

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.

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. Twenty of the 24 device types, however, may still be cleared through the 510(k) process. Further, there are other preamendment class III device types that did not happen to have any 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.

Relatively Few Class II and Class III 510(k) Submissions Had a New Intended Use or New Technological Characteristics

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. 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.

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.

All 510(k) Submissions That FDA Cleared Had the Same Intended Use and Most Had the Same Technological Characteristics as Predicate Devices

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.)

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 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.

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 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 not providing adequate data early in the review or not having a predicate device (see table 6).

Conclusions

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 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.

Recommendation for Executive Action

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.

Agency Comments

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 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 listed in appendix VII.

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, including the name of the device, the FDA-assigned product code, 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. 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 real- time supplements, which are requests for approval for a minor change to a device, such as a minor change in design, sterilization, software, or labeling.

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.

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 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.

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.

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.

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.

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. Under FDA’s Accredited Persons Program, device manufacturers may contract with accredited organizations (third parties) to review certain 510(k) submissions for a negotiated fee. 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. 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.

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. 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 life- sustaining 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. An FDA official familiar with the program stated that the third-party review program may be more attractive to device manufacturers because third- party 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 the third-party review program in terms of timeliness may diminish, which could lead to fewer third-party review 510(k) submissions.

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

Appendix III: FDA’s Implementation of Safe Medical Devices Act Provisions

The Safe Medical Devices Act of 1990 (SMDA) amended the definition of class II devices 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.

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. 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.

Appendix IV: 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).

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).

Appendix VI: Comments from the Department of Health and Human Services

Appendix VII: GAO Contact and Staff Acknowledgments

Acknowledgments

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.

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