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Regulatory

Building a U.S. 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 monitoring device safety, 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.

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