FDA Product Code PHC: Infusion Safety Management Software
Drug delivery errors in infusion therapy can have life-threatening consequences. FDA product code PHC covers infusion safety management software used to prevent medication errors.
These clinical decision support systems implement drug libraries with dose-error reduction software that alerts clinicians to potentially unsafe infusion rate and concentration settings before programming begins. They are integrated with smart infusion pumps to create a safety net against programming errors.
PHC devices are Class II medical devices, regulated under 21 CFR 880.5725 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Icu Medical, Inc., Baxter Healthcare Corporation and Becton Dickinson.
FDA 510(k) Cleared Infusion Safety Management Software Devices (Product Code PHC)
About Product Code PHC - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code PHC since 2014, with 10 receiving FDA clearance (average review time: 290 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
FDA review times for PHC submissions have been consistent, averaging 264 days recently vs 302 days historically.
PHC devices are reviewed by the General Hospital panel. Browse all General Hospital devices →