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. 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. Postmarket Oversight of Voluntary Medical Device Recalls

Overseeing recalls is an important element of FDA’s postmarket  responsibilities. FDA’s role is generally to oversee a  firm’s management of a 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. 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. 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. 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. However, FDA has not routinely used these recall data as a surveillance  tool or for examining broad trends of medical device recalls. FDA Inconsistently Assessed the Effectiveness of Recalls

Our preliminary analysis revealed inconsistencies in FDA’s assessments of  the effectiveness of recalls. 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 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. 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. 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. Related GAO Products

High Risk Series: An Update. Food and Drug Administration: Opportunities Exist to Better Address  Management Challenges. 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. This is a work of the U.S. government and is not subject to copyright protection in the  United States.
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.