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CDRH Down-Classifies Mandibular Condyle Plate


Posted in Regulatory and Compliance by Jamie Hartford on February 19, 2014

By Jim Dickinson

A CDRH guideline issued in January is intended to serve as the special controls to support the reclassification of the temporary mandibular condyle reconstruction plate (TMCRP) from Class III to Class II (special controls). 

A TMCRP is a device intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone, according to the center. The device is not intended for treatment of temporomandibular joint disorders, it notes.

The guideline identifies measures that CDRH believes will mitigate risks associated with TMCRPs and provide a reasonable assurance of safety and effectiveness. The center says firms submitting a 510(k) for a TMCRP must either comply with the particular mitigation measures set forth in the special controls guideline or use alternative mitigation measures but demonstrate to the agency’s satisfaction that those alternative measures will provide at least an equivalent assurance of safety and effectiveness.

Jim Dickinson is MD+DI's contributing editor.

 


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