Implementation of reorganization to begin for CDRH
In order to create a smart and quick-moving infrastructure that can adapt to the needs of future organizational, regulatory and scientific requirements, the Center for Devices and Radiological Health (CDRH) is beginning the implementation of a reorganization.
The reorganization will integrate CDRH’s premarket and post-market program functions along product lines, allowing their experts to leverage their knowledge to optimize decision-making across the product life cycle. This type of approach blends many of the current aspects of product review, quality, surveillance and enforcement into a new, team-based approach. With the implementation of reorganization, the FDA aims to enhance information-sharing across the Center, increase collective decision-making, improve work-life balance and increase professional opportunities for employees.
The implementation is set to begin March 2019 and is expected to be completed by September 2019. FDA says the implementation will take place in a phased approach, and timelines for implementation will vary by office. Each office within the current CDRH structure is undergoing some change in order to better support and advance CDRH’s public health mission and vision.
More information can be found here.
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Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients
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CDRH & CBER:
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Refuse to Accept Policy for 510(k)s
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Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research
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