FDA 21 CFR Part 878 General and Plastic Surgery Devices:
Click the title below for complete guidelines
Table of contents
Subpart A - General Provisions
878.3 Effective dates of requirement for premarket approval.
Subpart B - Diagnostic Devices
878.1800 Speculum and accessories.
Subpart D - Prosthetic Devices
878.3250 External facial fracture fixation appliance.
878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
878.3530 Silicone inflatable breast prosthesis.
878.3540 Silicone gel-filled breast prosthesis.
878.3610 Esophageal prosthesis.
878.3750 External prosthesis adhesive.
878.3800 External aesthetic restoration prosthesis.
878.3900 Inflatable extremity splint.
878.3910 Noninflatable extremity splint.
878.3925 Plastic surgery kit and accessories.
FDA 21 CFR Part 878 General and Plastic Surgery Devices: