New PMA Advisory Panel Procedures Enacted by FDA

The U.S. Food and Drug Administration (FDA) has changed its medical device premarket review process. According to officials in the FDA’s Center for Devices and Radiological Health (CDRH), the move follows a growing number of medical device advisory panel meetings in the past several years.

In 2008, there were 10 panel meetings covering 14 major topics. In 2009, there were 17 meetings on 20 topics, and 2010 is on track to surpass those numbers, according to CDRH officials. The FDA hoped that the changes, which went into effect on May 1, allow review panels to use their time more effectively.

Under the new system, the panel no longer will vote on a device’s approvability or conditions of approval but rather on the safety and effectiveness of a device and its risk versus its benefit. The change is aimed at allowing panel members to address areas of scientific expertise, rather than regulatory issues with which they might not be familiar.

The mode of the deliberation is new as well. Panelists will be instructed to present their scientific opinions and recommendations without interruption during an hour-long deliberation, during which the panel may ask questions of both the medical device firm’s representatives and the FDA.

“We believe focusing the amount of time the sponsor may respond to questions to the panel will allow for a more robust discussion among the experts and provide CDRH with information needed to reach a decision regarding the issue before the panel,” according to CDRH officials.

The method of voting also changed. Experts now will vote using an electronic ballot instead of raising their hands simultaneously, according to the FDA statement.

“The ballot process allows each panel member to cast their vote without immediate influence by other votes,” according to a statement released by the agency.

In addition, unlike in the past when CDRH reviewers presented a unified, consensus analysis of supporting data, they now will present that data and analysis in addition to the range of scientific opinion of group members. This move will allow more in-depth discussion on safety and effectiveness and risk versus benefit of the device under consideration, officials said.

“By taking a broader view of the data that is supplied and the opinions of different reviewers and offices within CDRH, we will provide the panel the ability to have a more in-depth discussion on safety and effectiveness and risk versus benefit of the device at issue,” CDRH Director Jeffrey Shuren said in a statement.

The FDA and CDRH will continue to evaluate panel procedures and make changes when necessary.

In addition to these specific changes to the advisory committee procedures, the FDA also issued draft guidance for disclosing and minimizing financial conflicts for advisory committee members.