Daily Rules, Proposed Rules, and Notices of the Federal Government
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FDA's Center for Devices and Radiological Health (CDRH) is responsible for protecting the public health by assuring the safety and effectiveness of medical devices and safe radiation-emitting products. A key part of this mission is to monitor medical devices and radiological products for continued safety and effectiveness after they are in use and to help the public get the accurate, science-based information they need to improve their health.
Several high-profile device performance concerns have led some to question whether CDRH's current postmarket surveillance system is optimally structured to meet the challenges of rapidly evolving medical devices and the changing nature of health care delivery and information technology. In their report entitled “Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years” published in July 2011, the Institute of Medicine recommended that FDA develop and implement a comprehensive medical device postmarket surveillance strategy to collect, analyze, and act on medical device postmarket performance information. As part of the process of developing and implementing this strategy, FDA is holding a public meeting to discuss the current and future state of medical device postmarket surveillance. Prior to this public meeting, FDA intends to issue a preliminary report on CDRH's plan to strengthen the medical device postmarket surveillance system in the United States. FDA intends to solicit public feedback regarding the report contents.
We intend to solicit public feedback regarding the medical device postmarket surveillance system in the United States. Specific topics of interest include, but are not limited to, the following: (1) The unique device identifier system and its incorporation into health-related electronic records; (2) national and international device registries for selected products; (3) adverse event reporting and analysis; and (4) developing and using new methods for evidence generation synthesis and appraisal. These topics will also be discussed in relation to the Sentinel provision in the FDA Safety and Innovation Act calling for the expansion of the postmarket risk identification and analysis system to include devices. Key questions for feedback include:
• Are these the right efforts?
• What principles should drive these efforts?
• What are the attributes of an effective “active surveillance” system for devices?
• How can the device active surveillance system leverage existing systems (e.g., Sentinel)?
Following public comment, FDA intends to have a moderated discussion session regarding strengthening the national medical device postmarket surveillance system.