Prediction: The FDA will shift to EU model of post-market evaluations |

Prediction: The FDA will shift to EU model of post-market evaluations

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 (Orthopedics This Week)

The U.S. relies on gathering clinical data to show a device is safe and effective before the FDA will grant approval. But that’s changing, according to a new study.

Harlan Krumholz, M.D., the Yale University professor who was hired by Medtronic plc to review all the Infuse data, has just co-authored a study that found that “the generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket [PMA] to continual study throughout the total product life cycle.”

That’s how the Europeans do it. They get devices out to patients faster, but require more post-approval data through device registries and other means.

Krumholz, along with post graduate student Vinay Rathi and others said that their study shows that many high-risk therapeutic devices get FDA approval with only one study proving their safety and efficacy before going to market.

The researchers looked at all clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through and publicly available FDA documents as of October 2014.

Here’s what they found.

  • Eight high-risk therapeutic devices received initial marketing approval via the PMA pathway. They also identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS (post-approval studies), and 171 (59.8%) manufacturer/investigator-initiated postmarket studies.
  • Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed.
  • No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall.
  • Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer/investigator-initiated postmarket studies, respectively.
  • Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]; ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR, 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively.

They concluded that among high-risk therapeutic devices approved via the FDA PMA pathway, “total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval.”