	Background

The Medical Device Amendments of 1976 established three classes of  medical devices. 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. 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. Table 1 summarizes the FDA review decisions, by class of device, in fiscal  years 2003 through 2007 for 510(k) and PMA submissions. 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. 4). 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. As of October 2008, FDA had reclassified 45 device types and published  regulations requiring PMAs for 53 device types.
Why GAO Did This Study

The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) is responsible for oversight of medical devices sold in the United States. Regulations place devices into three classes, with class III including those with the greatest risk to patients. Unless exempt by regulation, new devices must clear FDA premarket review via either the 510(k) premarket notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective. Class III devices must generally obtain an approved PMA, but until FDA issues regulations requiring submission of PMAs, certain types of class III devices may be cleared via the 510(k) process. The FDA Amendments Act of 2007 mandated that GAO study the 510(k) process. GAO examined which premarket review process--510(k) or PMA--FDA used to review selected types of device submissions in fiscal years 2003 through 2007. GAO reviewed FDA data and regulations, and interviewed FDA officials.

What GAO Found

In fiscal years 2003 through 2007, as part of its premarket review to determine whether devices should be permitted to be marketed in the United States, FDA: (1) reviewed 13,199 submissions for class I and II devices via the 510(k) process, clearing 11,935 (90 percent) of these submissions; (2) reviewed 342 submissions for class III devices through the 510(k) process, clearing 228 (67 percent) of these submissions; and (3) reviewed 217 original and 784 supplemental PMA submissions for class III devices and approved 78 percent and 85 percent, respectively, of these submissions. Although Congress envisioned that class III devices would be approved through the more stringent PMA process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete. GAO found that in fiscal years 2003 through 2007 FDA cleared submissions for 24 types of class III devices through the 510(k) process. As of October 2008, 4 of these device types had been reclassified to class II, but 20 device types could still be cleared through the 510(k) process. FDA officials said that the agency is committed to issuing regulations either reclassifying or requiring PMAs for the class III devices currently allowed to receive clearance for marketing via the 510(k) process, but did not provide a time frame for doing so.