On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled ...

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U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket ...

With a growing portfolio of regulatory filings, including a 510 (k) premarket notification and a registered FDA Device Master File, AIML is committed to rigorous validation and broad interoperability.