At a recent conference, CDRH Director Jeff Shuren remarked that the publication of the center’s final rule on the transition to a new quality system regulation for medical devices was a top priority for the agency, and that he “hoped” to have it completed by the end of the calendar year. However, according to AgencyIQ’s analysis, a variety of factors make it unlikely that CDRH will be able to realize those hopes.
The Quality Management System Regulation (QMSR) and timing.
QSR, QMSR and ISO 13485: The current medical device quality system regulations (QSR) are U.S.-specific. Outlined at 21 CFR 820, they set regulatory standards for facilities and controls for medical device manufacturing, packaging, storage, and installation.
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