GAO study finds 510(k)-cleared devices account for 94% of unplanned postmarket safety studies

Industry and the FDA are striving toward faster approval times counterbalanced by increased postmarket monitoring as they aim to optimize med tech regulation.

Because in order to achieve its vision of protecting patient safety while getting innovative devices to market faster (as exemplified by new initiatives like the Expedited Access Pathway for accelerated approval of critical devices) the FDA needs to improve its use and collection of postmarket data.

A study in The Journal of the American Medical Association concluded that only one of 223 postapproval studies between 2005 and 2011 resulted in any action other than a change in labeling. No warning letters were issued as a result of the studies. An optimist might say that this reflects the strength of the premarket review process, but periodic safety scares like the controversy around power morcellation and metal-on-metal hip debacle show that some unsafe devices inevitably slip through the cracks.

Rep. Rosa DeLauro

The GAO study, issued at the request of Rep. Rosa DeLauro (D-CT), analyzed the 313 postapproval market studies and 392 postmarket surveillance studies conducted between 2007 and February 2015. The FDA often requires specified postapproval studies be conducted as a condition of marketing approval, and can order surveillance studies lasting as long as three years at any time in order to inspect possible safety issues.

Among postmarket studies, 94% were ordered to monitor devices approved via the stringent PMA approval process. Among surveillance studies, 94% were ordered to monitor devices cleared via the less-stringent 510(k) process. The dichotomy reflects the lower data collection requirements for 510(k) devices during premarket review, and nearly demonstrates the interaction between the pre- and postmarket regulatory regimes.

The Pew Charitable Trust's medical device initiative pointed out in an email to FierceMedicalDevices that the GAO report claims patient enrollment often delays postapproval studies, and said the use of Unique Device Identifiers (UDI) and data registries can help fill the gaps in studies with small sample sizes or inadequate enrollment. In fact, one-third of the FDA postapproval studies analyzed relied on registries.

Pew and other think tanks like the Brookings Institution are advocating for a public-private partnership to strengthen the postmarket data registry network and increase their use further.

Meanwhile, GAO says that out of the 313 postmarket approval studies analyzed, 176 (56%) were for heart valves and stents. Almost 70% were observational prospective cohort studies--or studies in which a group using a particular device was compared to a second group not using the device for time frame as along as 10 years. An additional 7% were randomized clinical trials and 6% were bench or lab studies.

Finally almost three-fourths of studies are ongoing, 20% are completed and 8% were withdrawn because the study was revised, or the PMA submission withdrawn, among other reasons.

The vast majority of the surveillance studies (354, to be precise) were for orthopedics, devices used in general and plastic surgery, as well as those used in obstetrics and gynecology procedures, reflecting the well-documented safety issues of two sets of 510(k)-cleared devices: metal-on-metal hips and implantable vaginal mesh.

A surprising 88% of the studies were deemed inactive. That's because several such studies (31%) had been consolidated into a larger study of the same device type, while 28% were terminated due to a change in the device's indication for use. And in an additional 38% of those inactive studies, the device was withdrawn or redesigned.

The FDA's device arm is increasingly talking about the importance of postmarket data surveillance, and it is taking action too. In June it issued a safety warning to cardiologists based on troubling postmarket data among patients on the SynCardia Systems' Total Artificial Heart Companion 2 Driver System who underwent certain preimplant interventions.

- read the GAO report