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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Summary:
Why GAO Did This Study

The Food and Drug Administration (FDA) is responsible for overseeing medical devices sold in the United States. In general, new devices are subject to FDA review via either the 510(k) premarket notification process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective. FDA also has broad responsibilities for postmarket surveillance of devices, including oversight of recalls. A recall involves the correction or removal of a product from the market and is an important remedial action that can mitigate the risks associated with a defective or unsafe medical device. In recent years, GAO has identified a wide variety of concerns related to FDA's ability to fulfill its mission of protecting the public health and added FDA's oversight of medical products, including devices, to its list of high-risk areas. This statement provides an update on FDA's actions in response to a recommendation made in GAO's report, Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process ( GAO-09-190 , January 15, 2009). It also contains preliminary information on FDA's oversight of medical device recalls. Because of the preliminary nature of this work, GAO is not making recommendations at this time.

What GAO Found

FDA has begun to take steps to address GAO's 2009 recommendation about high-risk devices that are allowed to enter the U.S. market through the less stringent 510(k) process, but progress has been limited. High-risk devices include those which are implantable or life sustaining. In 2009, GAO recommended that FDA expeditiously take steps to issue regulations for the device types classified as high risk that are currently allowed to enter the market via the 510(k) process. Since then, FDA has set strategic goals to address these device types, but has issued a final rule regarding the classification of only one device type. As of April 1, 2011, FDA's action on the 26 remaining types of high-risk devices was incomplete. Thus, these types of devices--such as automated external defibrillators and implantable hip joints--can still enter the U.S. market through the less stringent 510(k) process. GAO found that, since its report was issued in January 2009, FDA has cleared at least 67 510(k) submissions that fall within these high-risk device types. FDA has taken some additional steps to enhance premarket device safety since GAO's 2009 report was issued--for example, it commissioned the Institute of Medicine to conduct an independent review of the premarket review process--but it is too early to tell whether any forthcoming changes will enhance public health. GAO's preliminary analysis shows that, from 2005 through 2009, firms initiated 3,510 voluntary medical device recalls, an average of just over 700 per year. Although FDA maintains extensive information on each recall, it has not been routinely analyzing recall data that would allow it to explain trends in recalls over time, thus missing an opportunity to proactively identify and address the risks presented by unsafe devices. GAO's preliminary work also identified several gaps in the medical device recall process that limited recalling firms' and FDA's abilities to ensure that the highest-risk recalls were being implemented in an effective and timely manner. GAO found that firms frequently were unable to correct or remove all devices subject to the highest-risk recalls. GAO's preliminary findings indicate that FDA lacks clear guidance for overseeing recalls which has led to inconsistencies in FDA's assessments of whether individual recalls were implemented effectively. Consequently, FDA officials examining similar situations sometimes reached opposite conclusions regarding whether recalls were effective. In addition, FDA had not established thresholds for assessing whether firms effectively completed recalls by correcting or removing a sufficient number of recalled devices. Further, GAO determined that FDA's decisions to terminate completed recalls--that is assess whether firms had taken sufficient actions to prevent a reoccurrence of the problems that led to the recalls--were frequently not made within its prescribed time frames. Finally, GAO found that FDA did not document its justification for terminating recalls. Taken together, GAO's preliminary work suggests that the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market.