FDA Issues Draft Report for National Medical Device Evaluation System

September 11, 2015—The US Food and Drug Administration (FDA) recently made available for public comment the draft report, “Recommendations for a National Medical Device Evaluation System: Strategically Coordinated Registry Networks to Bridge Clinical Care and Research,” which was developed by the  Medical Device Registry Task Force and Medical Devices Epidemiology Network. The complete 141-page document is available online here.

The FDA advised that it has established a docket where interested persons may submit comments by October 26, 2015. Comments can be submitted in writing to the FDA's Division of Dockets Management or electronically at http://www.regulations.gov.

The background of the document was summarized in the FDA announcement. In September 2012, the FDA published a report, “Strengthening Our National System for Medical Device Postmarket Surveillance,'' which proposed a strategy for improving the current system for monitoring medical device safety and effectiveness. In April 2013, the FDA issued an update to the September 2012 report that incorporated public input received and described the next steps toward fulfilling the vision for building a national postmarket surveillance system. These reports are available on the FDA’s website here.

One of the next steps consisted of establishing a multistakeholder Medical Device Registry Task Force to promote the development of national and international device registries for selected products. Under a cooperative agreement with the FDA, Duke University convened the Medical Device Registry Task Force as a part of the Medical Devices Epidemiology Network public-private partnership in 2014.

The Task Force membership included representatives from a broad array of stakeholder groups and areas of expertise, including patients, provider organizations, hospitals, health plans, industry, government agencies, as well as methodologists and academic researchers.

The Medical Device Registry Task Force was charged to: (1) identify existing registries that may contribute to the system; (2) leverage ongoing registry efforts focused on quality improvement, reimbursement, patient-centered outcomes, and other activities to best meet the needs of multiple stakeholders; (3) identify priority medical device types for which the establishment of a longitudinal registry is of significant public health importance; (4) define registry governance and data quality practices that promote rigorous design, conduct, analysis, and transparency to meet stakeholder needs; and (5) develop strategies for the use of registries to support premarket approval and clearance.