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FDA
The FDA Regulatory Challenges of Software Interoperability and Part 806
By Casper E. Uldriks The verification of design specifications and functional validation of software is predicated on its intended use with a particular device or as a “stand alone” device. The U.S. Food and Drug Administration (FDA) and the industry have understood and used software validation principles ever since the enactment of the Medical Device
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What’s Important in Assessing the Need for Additional 510(k) Clearance for Medical Device Changes?
Medical device companies often find themselves in a bind if the U.S. Food and Drug Administration (FDA) scrutinizes their decisions that product changes did not trigger the regulatory requirement for a new 510(k) submission for the changed device. They often use a thought process that is unacceptable to FDA. In other cases, they do not