Devices

CDRH Reorganizes for Total Product Life Cycle

CDRH is implementing a reorganization that will combine the Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and the Office of In Vitro Diagnostics and Radiological Health into one super office — Office of Product Evaluation and Quality. It will be focused on a “Total Product Life Cycle” approach to medical device oversight, a Center notice says.

The reorganization, which will have an ongoing phased approach through 9/30, is intended to “enhance communication among CDRH staff and enable more efficient activities across the life cycle from premarket review to postmarket surveillance,” the Center says. “After full implementation, the reorganization will integrate CDRH’s premarket and postmarket program functions along product lines, allowing our experts to leverage their knowledge to optimize decision-making across the product life cycle. This type of structure consolidates and integrates many of the current aspects of product review, quality, surveillance and enforcement into a new, team-based approach.”

The reorganization, it says, will:

Establish the Office of Policy with two teams — Guidance, Legislation and Special Projects Team and the Regulatory Documents and Special Projects Team. There are no changes in function for CDRH Policy.
Establish the Office of Strategic Partnerships and Technological Innovation that combines the Science & Strategic Partnerships, Digital Health, Health Informatics and Innovation teams. There are no changes in functions within the different teams.
Realign Management Services within the Center to ensure administrative functions in CDRH are optimally aligned, structured, and deliver excellent service.

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