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Endodontic dry heat sterilizer proposed call for PMAs would require in-use data.

This article was originally published in The Gray Sheet

Executive Summary

ENDODONTIC DRY HEAT STERILIZER IN-USE TEST DATA FOR PMA SUBMISSIONS would be required under a proposed call for premarket approval applications published by FDA in the June 7 Federal Register. FDA says that PMAs for the preamendment Class III products "should contain a detailed discussion with supporting simulated- and in-use studies" of the risks identified by the agency and the effectiveness of the device being studied.
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