There is wide variation in both the number and the quality of premarket and postmarket studies on high-risk therapeutic devices approved by the Food and Drug Administration’s (FDA) Premarket Approval (PMA) pathway between 2010 and 2011, according to a study published Aug. 11 in the Journal of the American Medical Association.

The study, authored by Vinay K. Rathi, BA; Harlan M. Krumholz, MD, SM, FACC; Frederick A. Masoudi, MD, MSPH, FACC; and Joseph S. Ross, MD, MHS, identified all clinical studies of high-risk therapeutic devices that received initial market approval via the PMA pathway in 2010 and 2011. The studies were characterized by type, premarket or postmarket status, and design features, including enrollment, comparator and longest duration of primary effectiveness end point follow-up.

Results showed that in 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval through the PMA pathway. Overall, researchers identified 286 clinical studies of these devices. Eighty-two of the devices (29 percent) were premarket, and 204 (71 percent) were postmarket, among which there were 52 (18 percent) non-pivotal premarket studies, 30 (11 percent) pivotal premarket studies, 33 (11.5 percent) FDA-required postapproval studies, and 60 percent manufacturer/investigator-initiated postmarket studies. Six of 33 (18 percent) postapproval studies and 12 percent of manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 18 percent of devices; and three or fewer were identified for 46 percent of devices overall.

The authors conclude that among high-risk therapeutic devices approved via the FDA PMA pathway between 2010 and 2011, total product life cycle evidence generation varied in the quality and number of premarket and postmarket studies. Further, they found that approximately 13 percent of initiated postmarket studies were completed between three and five years after FDA approval.

“Some devices are currently being evaluated through ongoing studies that, if completed, will provide evidence on clinical outcomes for large numbers of patients with planned follow-up of a year or longer,” the authors explain. “However, most devices have been or will be evaluated through only a few studies, which often focus on surrogate markers of disease in small numbers of patients followed up over short periods of time and study indications that differ from the original FDA-approved indication,” they add. 

Keywords: Biomarkers, Biomedical Research, Device Approval, United States Food and Drug Administration

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