Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Classification of the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis, (Jun 9, 2026)

By WK Editorial Staff

The FDA is taking the action because it determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device.

The FDA classified the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis into class II (special controls). The special controls that apply to the device type will be part of the codified language for classification of the shoulder joint humeral (hemi-shoulder) ceramic head/ metallic stem cemented or uncemented prosthesis. The FDA believes the classification will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens (Final Rule, 91 Fed. Reg. 34152 (June 5, 2026)).

Dates.This order is effective June 5, 2026. The classification was applicable on December 16, 2022.

FederalRegisterIssuances: FinalRules FDCActNews MDeviceNews SafetyNews