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Nov 2, 20231 min read

USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption

Today (02 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...

Oct 6, 20221 min read

USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines

USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research finalized and released four Medical...