On March 18, 2019, FDA’s Center for Devices and Radiological Health (CDHR) begins a phased reorganization with wide-ranging implications for device makers.
Aimed at reducing inefficiencies, the plan will consolidate CDHR’s premarket and postmarket program functions by product line. Product review, quality, surveillance and enforcement will be integrated through the use of a team-based approach. Reviewers, compliance officers, and other staff members will be responsible for oversight for a given product throughout its development cycle and subsequent commercialization. This is in contrast to the current structure, in which a specific group is responsible for evaluating a device during a specific phase, such as conformance to standards, or post-market data analysis.
A newly-established Office of Product Evaluation and Quality (OPEQ) combines these previous entities into what FDA calls a “super office”: Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and Office of In Vitro Diagnostics and Radiological Health.
In addition, existing Science and Strategic Partnerships, Digital Health, Health Informatics and Innovation teams will be merged into a new Office of Strategic Partnerships and Technological Innovation. Team functions will remain the same.
A new Office of Policy will also be established, retaining existing CDRH policies, and other planned changes will impact administrative and communication functions. Some points of contact will change.
From the outside looking in, this appears to be a cost savings move that delivers some increased efficiencies, provided that OPEQ and the other offices are adequately staffed. A change like this could create disruption in the short term, and medical device companies need to be prepared for some confusion and “growing pains”. In the long term, it may be beneficial to have one CDRH team follow a given product from premarket to postmarket, to increase experience with the product type, preserve continuity and avoid time-consuming hand-offs at each stage.
FDA expects to complete the reorganization by the end of September 2019. For more information, see “Reorganization of The Center for Devices and Radiological Health”.