The regulatory vision and department plans: The FDA vision and WCMC role

 

The FDA leadership acknowledges that WCMC activities shaped the direction for future device surveillance system development. The infrastructure and methods that we developed and continue to develop are viewed as the basis for real-time active surveillance, allow considerations of expanding indications for devices, contribute to the assessment of the balance of benefits and harms, lead to less costly post-approval studies and advance the unique device identification process to make it clinically meaningful. The Figure 1 below is entrenched with FDA regulatory science and is developed based on success seen with WCMC MDEpiNet research efforts.

Figure 1. Regulatory vision of surveillance development for medical devices safety and effectiveness
Figure 1. Regulatory vision of surveillance development for medical devices safety and effectiveness

CONTACT US

  • Chairman's Office
    402 East 67th Street
    New York, NY 10065
    (646) 962-8009
  • 425 East 61st Street
    New York, NY 10065
    (646) 962-9409
More

Top of page