	Background

FDA may order a postapproval study for a device at the time FDA  approves that device for marketing through its premarket approval (PMA)  process or its humanitarian device exemption (HDE) process (for devices  that treat rare diseases or conditions).the length of a postapproval study, but according to FDA guidance, the   There are no statutory limits on  device manufacturer and FDA agree on the study plan, which includes a  study design (e.g., randomized clinical trial or other study design), the  study’s data source, and time frame for when the manufacturer will  complete required reports. In contrast, FDA may order a postmarket surveillance study at the time of  approval or clearance for certain devices or any time thereafter as long as  certain criteria are met. FDA Ordered Most Postapproval Studies for Cardiovascular Devices and Most Were Making Adequate Progress

		FDA Ordered Most Postapproval Studies for Cardiovascular Devices and Most Were Designed as Prospective Cohort Studies

Cardiovascular devices, such as stents and heart valves, accounted for  56 percent of the 313 postapproval studies ordered from January 1, 2007,  through February 23, 2015. 1.) In general, FDA orders a postapproval study  to obtain specific information on the postmarket performance of or  experience with an approved device. February 23, 2015, were for devices approved through the PMA  process. In terms of study design, more than two-thirds (69 percent) of the   313 postapproval studies ordered during the timeframe we examined  were prospective cohort studies—that is, studies in which a group   using a particular device was compared to a second group not using   that device, over a long period of time. 2.) Most of the Postapproval Studies FDA Ordered Were Ongoing and Making Adequate Progress, According to FDA

About 72 percent of the postapproval studies we examined (or 225 of the  313 studies ordered) were categorized as ongoing as of February 2015. An additional 20 percent were completed and the remaining 8 percent  were inactive. 3.) Further analysis of FDA data on the 225 ongoing postapproval studies  showed 81 percent (or 182 studies) to be progressing adequately, while  the remaining 19 percent (43 studies) were delayed as of February 2015. According to FDA officials, a key reason for a study’s delay may be  limited patient enrollment into the postapproval study. As table 5 shows, on average, these completed  postapproval studies took about 36 months, or 3 years, with the longest  study taking almost 7 years. FDA Ordered Most Postmarket Surveillance Studies for Orthopedic, General/Plastic Surgery, and Obstetrics/ Gynecology Devices and Many Were Consolidated into Ongoing Studies

		FDA Ordered Most Postmarket Surveillance Studies for Orthopedic, General/Plastic Surgery, and Obstetrics/Gynecology Devices Resulting from Concerns about Metal-on- Metal Implants and Certain Kinds of Implantable Surgical Mesh

FDA ordered 392 postmarket surveillance studies, half of which   (196 studies) were for orthopedic medical devices, from May 1, 2008,  through February 24, 2015. In 2011 alone, FDA ordered 176 studies   for orthopedic devices following safety concerns about metal-on-metal   hip implants, including potential bone or tissue damage from metal  particles. An additional 40 percent (or 158 studies) of the  postmarket surveillance studies FDA ordered were for devices used in  general and plastic surgery and obstetrics and gynecology procedures. FDA ordered 121 postmarket surveillance studies for devices in these  medical specialties in 2012, following safety concerns about the use of  implanted surgical mesh used for urogynecologic procedures, such as  severe pain. A study  might be categorized as inactive, for example, because it had been  consolidated, meaning that a manufacturer was able to combine an order  for a postmarket surveillance study with other related study orders into a  single study. The inactive category for postmarket surveillance studies includes studies with one of four FDA study  statuses: (1) other—that is, the study status does not fit another category, because, for example, the  device is no longer being marketed or is being redesigned; (2) consolidated—that is, the study was  one of many postmarket surveillance studies ordered and the manufacturer, with the approval of  FDA, consolidated these multiple studies into a single study; (3) terminated—that is, studies that were  terminated by FDA because they were no longer relevant (e.g., the manufacturer changed the  indication for use that was the subject of the postmarket surveillance study); or (4) withdrawn—that is,  studies that were withdrawn because the manufacturer demonstrated the objective of the study using  publicly available data and FDA agreed with the results. While 88 percent of the postmarket surveillance studies in our analysis  were inactive, the remaining 12 percent (or 48 studies) were either still  ongoing or completed as of February 24, 2015. Of the 40 ongoing postmarket surveillance  studies, more than half were progressing adequately, while the rest   were delayed. The 19 ongoing postmarket surveillance studies that FDA considered  to be delayed had been ongoing for an average of 49 months or about  4 years. According to  FDA, postmarket surveillance studies may be delayed for reasons  similar to postapproval studies, such as difficulty enrolling patients into  the study. Agency Comments

We provided a draft of this report to the Secretary of Health and Human  Services. HHS provided technical comments that were incorporated, as  appropriate.
Why GAO Did This Study

Americans depend on FDA—an agency within the Department of Health and Human Services (HHS)—to oversee the safety and effectiveness of medical devices sold in the United States. FDA's responsibilities begin before a new device is brought to market and continue after a device is on the market. As part of its postmarket efforts, FDA may order manufacturers to conduct two types of studies: (1) postapproval studies, ordered at the time of device approval, and (2) postmarket surveillance studies, generally ordered after a device is on the market.
GAO was asked to report on the characteristics and status of postmarket studies. This report describes (1) the types of devices for which FDA has ordered a postapproval study and the status of these studies, and (2) the types of devices for which FDA has ordered a postmarket surveillance study and the status of these studies. GAO analyzed FDA data—including data on medical specialty and study status as of February 2015—for (1) postapproval studies ordered from January 1, 2007, through February 23, 2015, and (2) postmarket surveillance studies ordered from May 1, 2008, through February 24, 2015. These represent the time periods for which FDA reported consistently tracking study data. GAO also reviewed documents, such as FDA guidance, and interviewed FDA officials.
HHS provided technical comments that were incorporated, as appropriate.

What GAO Found

Fifty-six percent of the 313 medical device postapproval studies—studies that are ordered at the time of device approval—the Food and Drug Administration (FDA) ordered from January 1, 2007, through February 23, 2015, were for cardiovascular devices and most were making adequate progress. Postapproval studies are ordered to obtain additional information not available before devices are marketed, such as a device's performance over the course of long-term use. In terms of study design, 69 percent of the 313 postapproval studies ordered were prospective cohort studies—that is, studies in which a group using a particular device was compared to a second group not using that device, over a long period of time. Most (72 percent) of the postapproval studies were ongoing as of February 2015, 20 percent of studies were completed, and 8 percent were inactive because, for example, the device is no longer marketed. Ongoing postapproval studies that GAO reviewed had been ongoing for an average of a little more than 3 years; FDA considered most of them (182 studies) to be progressing adequately and the rest (43 studies) to have inadequate progress or to otherwise be delayed. According to FDA officials, a key reason for a study's delay may be limited patient enrollment in the postapproval study. On average, manufacturers completed postapproval studies in about 3 years, with the longest study taking almost 7 years, for the studies that GAO reviewed.
Ninety percent of the 392 medical device postmarket surveillance studies FDA ordered from May 1, 2008, through February 24, 2015, were for orthopedic devices and devices such as certain kinds of implantable surgical mesh following concerns with these types of devices, and many were consolidated into ongoing studies. Unlike postapproval studies, FDA may order postmarket surveillance studies at the time or after a device is approved or cleared for marketing—for example, if FDA becomes aware of a potential safety issue. Safety concerns about metal-on-metal hip implants, including potential bone and tissue damage from metal particles, led to an increase in such studies ordered in 2011. Forty percent of the 392 ordered studies were for implanted surgical mesh and other devices used in general and plastic surgery and obstetrics and gynecology procedures. FDA ordered most of these studies in 2012, following safety concerns associated with implanted surgical mesh, such as severe pain. Eighty-eight percent of the postmarket surveillance studies GAO analyzed were inactive as of February 2015. Inactive studies include those that were consolidated (108 studies), meaning that a manufacturer was able to combine an order for a postmarket surveillance study with other related study orders into a single study, such as combining studies of multiple device models into a single study; and those that were inactive for other reasons, such as if the order was for a device that is no longer marketed. The remaining 12 percent of the postmarket surveillance studies were either still ongoing (40 studies) or completed (8 studies). Of the 40 ongoing studies, more than half were progressing adequately, according to FDA, and had been ongoing for an average of a little less than 3 years; the rest were delayed and had been ongoing for an average of about 4 years as of February 2015. According to FDA, postmarket surveillance studies may be delayed for reasons similar to postapproval studies, such as difficulty enrolling patients into the study.