FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process
GAO-09-190: Published: Jan 15, 2009. Publicly Released: Jan 15, 2009.
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.
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.
Recommendation for Executive Action
Comments: FDA has taken initial steps to respond to this recommendation; however we are leaving the recommendation open because the agency has not yet taken final steps to reclassify or require premarket approval (PMA) for 14 class III device types allowed to enter the market through the less stringent 510(k) process. In 2009, FDA began a 5-step process to reclassify or to require PMAs for 26 class III device types. This process was modified by the Food and Drug Administration Safety and Innovation Act (FDASIA)--instead of issuing regulations as the final step, FDA issues an administrative order to reclassify or require PMAs for the device types. As of August 2014, FDA had finished the final step in the process for 12 device type. The agency reported that it anticipates issuing a proposed order for all remaining devices by September 2014 and it has set a goal to have all remaining devices finalized by the second quarter of 2015.
Recommendation: The Secretary of Health and Human Services should 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 Affected: Department of Health and Human Services