FDA’s CDRH reorganization plans to launch next Monday

The FDA this week announced plans to reorganize its Center for Devices and Radiological Health, combining previously separate premarket review, postmarket surveillance and compliance offices and into one “super office” to better monitor products through their total product life cycle.

The changes are slated to begin next Monday and are expected to be completed by the end of September, according to an FDA release.

The FDA said that goal of the reorganization is to “improve organizational efficiencies to better meet public health needs,” commenting that its current system “does not always promote the type of communication and collaboration that is proving essential to the continuously evolving innovation of medical devices.”

The federal watchdog said that instead of assessing a device only at one point in time, teams will now monitor devices through their entire lifespans, with teams responsible for device oversight from development to commercialization.

With the reorganization, the federal watchdog will combine its 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 titled the Office of Product Evaluation and Quality.

The FDA said it will also establish two new offices – the Office of Policy, which will have both a Guidance, Legislation and Special Projects Team and the Regulatory Documents and Special Projects Team, and the Office of Strategic Partnerships and Technological Innovation, which will combine the Science & Strategic Partnerships, Digital Health, Health Informatics and Innovation teams. No changes in functions within the teams were noted.

The agency said it will also look to realign its management services to ensure optimal alignment, structure and delivery of administrative functions, and that it will be combining internal and external communication functions into its renamed Division of Communication in the Office of Communication and Education.

The FDA added that the reorganization will not change the mission of the CDRH or any MDUFA IV timelines.

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