FDA Calls Public Postmarket Surveillance Meeting

The Food and Drug Administration (FDA) is holding a public meeting on September 10, 2012 to solicit public feedback regarding FDA’s proposal to strengthen the national medical device postmarket surveillance system.

Prior to this public meeting, FDA intends to issue a preliminary report on plans to strengthen the medical device postmarket surveillance system in the U.S.

You can attend the meeting in person in Greenbelt, Maryland, or attend via a Webcast.

There have been some high profile cases of approved devices having to go back and perform 522 Postmarket Surveillance Studies. Makers of metal-on-metal hips and certain spine stabilization systems are currently undergoing postmarket studies.

Medical device manufacturers as well as other firms involved in the distribution of devices must follow certain requirements and regulations once devices are on the market. These include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.

If you wish to attend this meeting in person, you must register online by September 10, 2012. If you wish to view this meeting by Webcast, you must register by close of business on September 5, 2012.

There is no fee to register for the meeting and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to make an oral presentation during an open comment session at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

Meeting Topics

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;

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?

 Following public comment, FDA intends to have a moderated discussion session.

 For further information, click here.