NEP — System/Device, Pharmacy Compounding Class II

FDA Device Classification

FDA product code NEP covers "System/Device, Pharmacy Compounding", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel.

Classification Details

Product Code
NEP
Device Class
Class II
Regulation Number
880.5440
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No