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FDA No Longer Publishing Quarterly PMA And HDE Decisions

 
• By Brian Bossetta

The US FDA has stopped publishing its list of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemptions (HDEs) in the Federal Register on a quarterly basis. The agency says the change will save money and resources.

REGULATION HIGHLIGHTED
• Source: Alamy

The US Food and Drug Administration has issued a final rule amending its medical device regulations on how the agency publishes submission verdicts on premarket approval applications (PMAs) and humanitarian device exemptions (HDEs).

Effective on 14 February, the FDA is no longer publishing quarterly PMA and HDE approvals and denials in the Federal Register. The final rule, the FDA says, will save money,...

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