Artist: Tony YayoTitle: Thoughts of a Predicate FelonRating: 3 1/2 StarsReviewed by: Houston Williams Tony Yayo can set the tone of an album. Ain t nobody talkin when I m talking fellas so shut the f* ...
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, ...
FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications
The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.” This ...
Since the release of the Bitcoin whitepaper in 2008, blockchain has promised to create a new global payment network that would challenge incumbents, from banks to governments. That dream has often ...
The U.S. FDA’s concerns about the 510(k) program over the past decade-plus are practically the stuff of regulatory urban legend, but the agency has just unveiled a trio of draft guidances to address ...
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