Issuance by the U.S. Food and Drug Administration of the draft guidance Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices is the latest in a series of actions showing the agency’s determination to establish a national device evaluation system (often tagged the National Evaluation System for Health Technology, or NEST) despite significant obstacles. Those obstacles include administrative and financial burdens, skepticism among stakeholders and uncertainty about how such evidence can be used within the existing regulatory scheme. All indications are that the FDA will not be deterred: with the draft guidance, the agency adds fuel to an ambitious initiative that could transform not only the FDA’s regulatory oversight of devices, but also how devices are developed by manufacturers and reimbursed by payors.
FDA’s Pursuit Of A National Medical Device Evaluation System
August 9, 2016