On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, ...
INVESTIGATIONS of predicate offences can be more complex than solving mystery puzzles. Predicate offences are camouflaged in the darkness of a criminal environment. For example, tax evasion can ...
In a new final guidance issued today, the FDA announced that it will frown upon the use of multiple predicate devices in 510(k) submissions, unlike when it cleared metal-on-metal hip implants, which ...
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