Medical Devices: FDA's Premarket Review and Postmarket Safety Efforts
Released: 2011-04-13T00:00:00

Letter

Background

FDA classifies each device type into one of three classes based on the level of risk it poses and the controls necessary to reasonably ensure its safety and effectiveness. 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 class III: pacemakers and replacement heart valves.

Premarket Review of Medical Devices

Before medical devices may be legally marketed in the United States, they are generally subject to one of two types of FDA premarket review, unless exempt by FDA regulations. These reviews are: Premarket approval or PMA process: The manufacturer must submit evidence, typically including clinical data, providing reasonable assurance that the new device is safe and effective. The PMA process is the most stringent type of premarket review. A successful submission results in FDA’s approval to market the device.

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

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

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

Postmarket Oversight of Voluntary Medical Device Recalls

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

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

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

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

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

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

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

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

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

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

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

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

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

Based on our preliminary analysis, we provided key summaries to FDA officials and asked them to comment on trends that we observed. Officials indicated that they have not fully analyzed these data and could not explain trends without extensive research of individual case files. For example, they could not explain why the majority of recalls are class II, why class I recalls more than doubled between 2008 and 2009, or why many recalls had been ongoing for 5 years. Officials also could not provide definitive answers when we asked them to comment on other related topics, such as: trends in the number of recalls over time; variation in the numbers of recalls by recall classification levels; types of devices and medical specialties of devices accounting for most recalls; and length of time needed to complete or terminate recalls.

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

FDA Inconsistently Assessed the Effectiveness of Recalls

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

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

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

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

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

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

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

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

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

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

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

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

Contacts and Acknowledgments

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

Related GAO Products

High Risk Series: An Update. GAO-11-278. February 2011.

Food and Drug Administration: Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed. GAO-10-960. Washington, D.C.: September 30, 2010.

Food and Drug Administration: Opportunities Exist to Better Address Management Challenges. GAO-10-279. Washington, D.C.: February 19, 2010.

Food and Drug Administration: FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs. GAO-09-581. Washington, D.C.: June 19, 2009.

Medical Devices: Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments. GAO-09-370T. Washington, D.C.: June 18, 2009.

Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. GAO-09-190. Washington, D.C.: January 15, 2009.

High-Risk Series: An Update. GAO-09-271. Washington, D.C.: January 2009.

Health-Care-Associated Infections in Hospitals: Number Associated with Medical Devices Unknown, but Experts Report Provider Practices as a Significant Factor. GAO-08-1091R. Washington, D.C.: September 26, 2008.

Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk. 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.

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

Medical Devices: Status of FDA’s Program for Inspections by Accredited Organizations. GAO-07-157. Washington, D.C.: January 5, 2007.

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