The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...

The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year. The list of draft documents touches on many topics ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.