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

International Medical Device Regulators Forum (IMDRF) Registry Working Group

The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization. It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence. Weill Cornell provides leadership in the IMDRF Registry Working Group, which was created with the purpose of developing:

  1. Essential principles related to registries, international collaborations and linkage of registries with electronic patient, device and outcome and/or related data repositories or identifiers (such as UDIs), including the principles of data access, security, informatics formats, governance and other key areas related to global regulatory applications for medical device evaluation; and
  2. Essential principles related to optimal methodologies for analysis of heterogeneous data sources applied to medical device safety, signal detection, performance and reliability.

Additionally, we provide specialist advice to the Australian Therapeutic Goods Administration (TGA).


CONTACT US

  • Dr. Art Sedrakyan
    Department of Healthcare Policy & Research
    402 East 67th Street New York, NY 10065
    (646) 962-8072
    ars2013@med.cornell.edu
  • Courtney Baird
    Department of Healthcare Policy & Research
    402 East 67th Street
    New York, NY 10065
    (646) 962-8099
    ceb3003@med.cornell.edu
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