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 ...
Last week, the U.S. Court of Appeals for the District of Columbia Circuit invalidated CMS’s prohibition on appeals of so-called predicate facts. The appeal before the court, described in greater ...
FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications
The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.”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 ...
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 In draft guidance (PDF), the FDA set out how sponsors can win clearance for ...
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 ...
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 ...
A great deal of Java programming -- from conditional statements to iterative loops -- deals with the evaluation of true or false values. When you work with the JDK's Streams API and Lambda functions, ...
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