FDA Proposes End To Quarterly Reporting On HDE, PMA Decisions
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.
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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.
It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one.
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