FDA Archives - Page 14 of 17

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“New draft guidance from the US Food and Drug Administration proposes Good Clinical Practice (GCP) compliance for accepting medical device clinical data from studies conducted in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...

Ever-Changing FDA Rules to Affect Class II Devices in September ’16

In a new article from MDDIonline.com, “FDA rules require medical device labelers to submit data to the Global Unique Device Identification Database (GUDID) for the highest-risk medical devices and will soon expand to moderate risk (Class II) devices in September...

FDA Grants Premarket Approval for New Heart Pump

The FDA has approved the first hemodynamic support device from AbioMed. The Impella 2.5 System has gained “premarket approval for use during high risk PCI procedures” according to an article via Forbes.com. The blood pump will be a temporary device for...

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...

Do FDA Regulations of Medical Devices Need to be Reevaluated?

According to an article from the Wall Street Journal, “The Food and Drug Administration works at striking the proper balance between insisting on safety but not standing in the way of innovative products that promote health and well-being. In doing so, it’s...

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