CDRH Proposes Nationwide Postmarket Surveillance System

The Center for Devices and Radiological Health has proposed a National Medical Device Postmarket Surveillance System (MDS). It is expected that the MDS will serve the needs of:

   •   Patients and clinicians who need information about devices to inform their clinical decisions
   •   Payors who seek assurance that the products they cover lead to optimal patient outcomes
   •   Manufacturers that want timely feedback on device performance to support patient safety and drive innovation

A multi-stakeholder Planning Board has formed to identify governing policies, priorities and business models needed to develop a robust system. Latter portions of a suggested 7-year implementation approach include:

   •   Support of a “multi-pronged approach” to ensure widespread adoption and use of Unique Device Identifications in electronic
        health care data
   •   Minimizing the burden of data capture and sharing
   •   Building capabilities to provide value to a broad group of stakeholders

For manufacturers, the MDS could offer benefits such as better, timelier information on device performance, as well as more effective recall management. Further, the system may support regulatory and reimbursement decisions about marketed products, as well as expanded indications for use and additional innovation throughout a product’s life cycle, because it could offer the ability to examine safety and efficacy in particular patient populations, or in comparison to other treatment modalities.

To be considered as valuable—and sustainable—the MDS will need ongoing assessment of its functional and financial value to all stakeholders. Ideally, pilot testing programs would demonstrate to FDA and the public that evidence generated through this system is more reliable, accurate and timely than the current reporting requirements (e.g., MDRs).

The Planning Board estimates that the cost to implement and maintain the system over the first five years would be approximately $200–250 million in Federal and private sector funding.

The Brookings Institution full report on the proposed MDS is found here.