FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications
The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.”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 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U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket ...
The U.S. Food & Drug Administration issued select updates to premarket cybersecurity guidance on March 13, including who is required to comply, the types of devices that fall under certain agency ...
To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, ...
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