FDA Public Meeting Will Address Postmarket Surveillance System

August 27, 2012—The US Food and Drug Administration (FDA) announced that it will conduct a public meeting entitled: Strengthening the National Medical Device Postmarket Surveillance System. The meeting will be held on September 10 from 9:00 AM to 4:00 PM at the Greenbelt Marriott Hotel in Greenbelt, Maryland. The notice with complete meeting details is available on the FDA website.

According to the FDA notice, the meeting will include a public comment session and a moderated discussion session. During online registration, attendees can indicate if they wish to present during a public comment session or participate in a specific session and which topics they would like to address.

The FDA is soliciting public feedback that can be submitted until October 9 in electronic or written comments on all aspects of the meeting topics. All requests to make oral presentations must be received by August 31, and any presentation materials must be submitted by September 5, 2012.

The FDA stated that specific topics of interest include, but are not limited to, the unique device identifier system and its incorporation into health-related electronic records, national and international device registries for selected products, adverse event reporting and analysis, and 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 (such as Sentinel)?