Medical Device Compliance

The goal of the Probability Sampling Study (P.S.S.) is to evaluate risk factors that contribute to the state of regulatory compliance for medical device clinical investigations. The results of the P.S.S. can be used to direct limited FDA resources into areas where there may be enhanced concern for human subject protection and/or clinical data quality systems. The data from the probability sample can be extrapolated to the entire universe of medical device clinical investigators.

FDA inspected 200 randomly selected clinical investigators as part of the P.S.S. between August 4, 2003, and March 20, 2007. Ultimately, FDA issued eight Warning Letters (WLs)1 to clinical investigators. At the eight investigator sites receiving WLs, a statistical analysis of variables demonstrates a strong correlation between: the site being inspected for the first time by FDA, investigators that did not receive sufficient training on the conduct of the study, and the site being monitored by the sponsor of the investigation.

This correlation and relationship to WLs supports the need to increase education and training for both clinical investigators and sponsors.