FDA 21 CFR Part 878 General and Plastic Surgery Devices

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Table of contents

Subpart A - General Provisions

878.1 Scope.

878.3 Effective dates of requirement for premarket approval.

878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B - Diagnostic Devices

878.1800 Speculum and accessories.

Subpart C [Reserved]

Subpart D - Prosthetic Devices

878.3250 External facial fracture fixation appliance.

878.3300 Surgical mesh.

878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.

878.3530 Silicone inflatable breast prosthesis.

878.3540 Silicone gel-filled breast prosthesis.

878.3550 Chin prosthesis.

878.3590 Ear prosthesis.

878.3610 Esophageal prosthesis.

878.3680 Nose prosthesis.

878.3720 Tracheal 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.

Subpart E - Surgical Devices, (and)

Subpart F - Therapeutic Devices

FDA 21 CFR Part 878 General and Plastic Surgery Devices: