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Medical Devices / Research and Development

‘Blind’ PMA Panels More Likely to Give Thumbs Up, Analysis Finds

July 12, 2018

Changes to premarket approval application advisory panels appear to have made it easier for panelists to say yes to medical devices, a new analysis finds.

The FDA changed rules governing the panels in 2010, creating a “blind,” simultaneous voting system—where all panelists vote at the same time and don’t discuss their vote. Previously, panelists had voted publicly and sequentially.

The agency also changed the question panelists had to ask about a proposed medical device. Before 2010, panelists were asked to vote only on whether a device should be approved. Now, panelists vote separately on whether the device is safe, effective and whether the benefits outweigh the risks.

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