Physicians need technology that helps them track disease progression and response to therapy.
COVID-19 requires us to rethink our current device disinfection procedure.
Managing suppliers is critical, and your processes in doing so must be documented.
The agency has issued its list of the most common inspectional observations for FY 2017.
When it comes to compliance, the FDA does not grant special dispensation.
How you respond to Form 483 observations matters.