Purpose: In order to address increasing demands for faster evaluation and approval of medical devices, the FDA enacted the FDA Safety and Innovation Act (FDASIA) in 2012. This policy placed provisions in the regulatory pathway to decrease time to evaluation in an effort to provide faster access to novel medical technologies. The purpose of this study is to quantify pre- and post- FDASIA pivotal clinical trial characteristics.
Material and Methods: The following analyses were conducted to assess pre- and post- policy changes: (1) descriptive statistics over the devices pre/post policy; (2) test of independence pre/post policy for set of the variables mentioned above; (3) ANOVA to test the difference of mean pre/post policy (continuous variables); and, (4) a logistic regression of post-approval study requirements regressed upon all of the other variables pre- and post- FDASIA. Post-approval study requirements were used as a proxy for “degree of success”, and therefore identified as a the outcome variable.
Results: The descriptive statistics of the devices pre- and post--policy provide a basis of comparison in the characterization of these endovascular devices (Table 1.) An independence test was conducted for each of the variables between the device classes for the devices pre- and post- FDASIA (Table 2). Moreover, the ANOVA results of the mean number of devices per year pre- and post- FDASIA demonstrate a p-value of 0.62 (Figure 1) thus suggesting that there is no statistical significance in the average number of devices between the two periods. The logistic regression results of the pre-FDASIA illustrate that randomization and comparators are significant in the prediction of post-approval study requirements with p=0.0272 and p=0.0223 respectively (Table 3).
Conclusions: Strong evidence to conclude that the FDASIA has impacted pivotal clinical trial requirements for successful pre-market approval of novel endovascular devices.