draft guidance

FDA Issues Draft Guidance on Multiple Function Device Products

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance intended to clarify its policy regarding the assessment of medical devices offering multiple functions.

U.S. FDA Releases Draft Guidance on Demonstrating Substantial Equivalence

The FDA has released a draft guidance that may help reduce the burden on device manufacturers seeking to demonstrate substantial equivalence for some types of new medical devices.

Draft Guidance Available from FDA “Medical Device Reporting for Manufacturers”

A draft guidance entitled “Medical Device Reporting for Manufacturers” has been released from the...

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