On March 13, 2019 the U.S. Food and Drug Administration (FDA) announced The Center for Devices and Radiological Health (CDRH) is beginning implementation of a reorganization that FDA hopes will create an agile infrastructure that can adapt to future organizational, regulatory and scientific needs. Since June 2018, the Agency has been piloting a more integrated approach to device safety throughout the Total Product Life Cycle (TPLC). Although CDRH has applied a TPLC holistic approach to devices for many years, the FDA intends the reorganization to enhance communication among CDRH staff and enable more efficient activities across the life cycle from premarket review to postmarket surveillance.
The implementation will be phased in over the next 6 months and includes the formation of three new offices under the restructuring plans: the Office of Policy, the Office of Strategic Partnership and Technological Innovation, and a new ‘Super Office’ deemed the Office of Product Evaluation and Quality (OPEQ). OPEQ combines the Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and the Office of In Vitro Diagnostics and Radiological Health. Throughout CDRH, personnel will move to groupings based on product category instead of geographic location. This reorientation is aimed at enhancing communication among reviewers, compliance officers, experts and management within CDRH to strengthen the relationship with industry.
How will this affect medical device manufacturers?
During the phased implementation, there is no expected impact to business as usual. Once the implementation is complete, the reorientation should ensure more consistent policy application and streamlined decision making for CDRH staff making it easier for Regulatory professionals in industry to know what to expect. The ‘one-stop shop’ goal for CDRH of having the same staff work on technologies from premarket review to postmarket surveillance is good news for regulatory groups in small and large medical device companies to have the opportunity to know their team in CDRH very well and have better, more informed interactions.
Full implementation of the reorganization is expected to be completed by September 30, 2019. If you have any questions regarding the impact of the the CDRH reorganization on your firm, email us with your questions.