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FDA Proposes End To Quarterly Reporting On HDE, PMA Decisions

 
• By Elizabeth Orr

A proposal from the US FDA would end quarterly publication of PMA and Humanitarian Device Exemption verdicts in the Federal Register. The agency says the practice is inefficient and duplicates online publication.

FDA entrance sign 2016

The US Food and Drug Administration would stop publishing recent PMA and Humanitarian Device Exemption (HDE) approvals or denials in the Federal Register at the end of each quarter under a proposed rule issued on 17 December.

The agency says the move will increase efficiency and reduce duplicative announcements.

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