Beginning on Monday, March 18, the reorganization of CDRH will begin. The center is making an effort to become more efficient in order to “adapt to future organizational, regulatory and scientific needs” and expects the process to be complete by the end of September.
The reorganization includes the consolidation of the Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and the Office of In Vitro Diagnostics and Radiological Health into a super office called the Office of Product Evaluation and Quality (OPEQ). OPEQ will approach device oversight from a total product lifecycle perspective.
Two new offices will be created: the Office of Policy with a Guidance, Legislation and Special Projects Team, along with a Regulatory Documents and Special Projects Team; and the Office of Strategic Partnerships and Technological Innovation, which combines the Science & Strategic Partnerships, Digital Health, Health Informatics and Innovation teams.
In addition, CDRH will be streamlining its administrative functions, along with its internal and external communications, which will be called the Division of Communication in the Office of Communication and Education, and the Internal Communication Branch.
CDRH stresses that these changes will not affect the center’s mission or its MDUFA IV timelines.
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