FDA Guidance Archives - Q1 Productions

FDA Issues Final Ruling on Symbols in Device Labeling

According to Healthcare Packaging, “The U.S. Food and Drug Administration’s final rule on the ‘Use of Symbols in Labeling’ allows for the use of stand-alone symbols in medical device labeling, without adjacent explanatory text. The agency says the...

FDA Drafts Health Data Sharing Guidance for Medical Devices

According to Health IT Security, “The FDA has released draft guidance on health data sharing for medical device manufacturers to help alleviate patient privacy concerns. According to recent draft guidance from the Food and Drug Administration (FDA), medical...

FDA guidance outlines principles for adaptive design in device clinical trials

In a new article via MassDevice.com, the Embargo Group said, “New draft guidance from the US Food and Drug Administration lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued...

ICYMI: US FDA Explains Criteria for Accepting Medical Device Clinical Data from Foreign Studies

“New draft guidance from the US Food and Drug Administration proposes Good Clinical Practice (GCP) compliance for accepting medical device clinical data from studies conducted in foreign countries, and also outlines criteria the agency uses for accepting such...

FDA Examining Med Device Risk Assessments in Postmarket Settings

The FDA will host a public meeting on April 21 to further engage with the medical device industry on “assessing changes in medical device risk as quality and safety situations arise in the postmarket setting” according to an article from...

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