Predicate methods allow you to separate the criteria you're using to test items in a collection from the code that processes the collection. You may never write a For...Each loop again. Here are some ...
The FDA is planning to expand its abbreviated 510(k) program to lessen the burden of demonstrating substantial equivalence. In draft guidance (PDF), the FDA set out how sponsors can win clearance for ...
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, ...
Food and Drug Administration’s modernization plan for its 510(k) process may not be all sweet music to the industry. In a joint statement on Monday describing the modernization effort, Commissioner ...
The FDA should improve device safety by increasing the amount and availability of information about previously marketed devices, known as predicates. Most medical devices reach the market by ...
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 ...
The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket ...
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