Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Stolen Boston Scientific devices
You may also be interested in...
FDA Dx Office Plans Pilot 510(k) ‘Triage’ Program For Early 2012
FDA’s diagnostics office will begin a pilot program in early 2012 to triage its review of 510(k) submissions based on product risk and application quality.
FDA Dx Office Plans Pilot 510(k) ‘Triage’ Program For Early 2012
FDA’s diagnostics office will begin a pilot program in early 2012 to triage its review of 510(k) submissions based on product risk and application quality.
FDA Seeks PMA Requirements For More Pre-Amendment Devices
FDA is proposing to require pre-market approval applications for three class III, pre-amendment device types in the cardiovascular and neurologic device spaces.