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FDA’s Unprecedented Changes in Software Regulation

Software’s level of complexity and use keeps expanding at exponential levels. Likewise, the potential risks to health and loss of privacy follow suit. Ransomeware attacks hold software programs hostage until you pay the culprit thousands of dollars. Life suppo ...


FDA’s Tougher Import Program in 2018

Background: The FDA continues to change its import program to better manage new problems and to use new procedures to make the process more efficient.  The FDA and U.S. Customs and Border Protection (CBP) now require the use of computers to submit entry data. ...