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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

CDRH inspections database: Center launches 1database Sept. 30 of CDRH-led medical device inspections from 2008 to present. Inspections handled primarily by the Office of Regulatory Affairs are not included in the searchable database, so the database provides access to about 25% of device inspections conducted in the past two years. CDRH leads inspections of foreign facilities, as well as inspections related to Medical Device Reporting, labeling and software issues. The database can be found on the CDRH Transparency website. Clinical trial inspections are not included "because information about new medical device development is confidential," CDRH notes

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