In 2019, the FDA's Center for Devices and Radiological Health's (CDRH) reorganized to create an agile infrastructure that can adapt to future organizational, regulatory and scientific needs. This reorganization did not change the mission of CDRH or any MDUFA IV timelines.
On This Page:
- Why Did CDRH Reorganize?
- What Is the Benefit of the CDRH Reorganization?
- What Are the Changes to CDRH's Organizational Structure?
- Did My CDRH Points of Contact Change?
- Where Can I Send Questions?
- Additional Resources
The CDRH reorganization generates efficiencies that allow us to more fully realize the FDA and CDRH's public health mission and vision. The reorganization integrates 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.
Historically, CDRH has been organized according to the stage of the product's life cycle—premarket review, postmarket surveillance, and compliance—rather than holistically by the type of product being regulated. Although that structure allowed employees to become specialized by function, it did not always promote the type of communication and collaboration that is proving essential to the continuously evolving innovation of medical devices.
Implementation of the Office of Product Evaluation and Quality (OPEQ) integrated CDRH's premarket and postmarket program functions along product lines, which enables 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 CDRH reorganization improves organizational efficiencies to better meet public health needs. CDRH's premarket and postmarket program functions will be integrated along product lines. This structure consolidates and integrates many of the current aspects of product review, quality, surveillance and enforcement into a new, team-based approach. Rather than assessing a device only at one point in time—for instance, to evaluate whether a device meets the standard for approval, or to evaluate postmarket data involving a device safety signal—reviewers, compliance officers and other experts work in teams responsible for device oversight throughout the product's development and commercialization.
Each office within the current Center structure underwent some change to better support and advance CDRH's public health mission and vision.
Previous CDRH Structure
Current CDRH Structure (Following Reorganization)
Office of Product Evaluation and Quality (OPEQ)
Implementation of the Reorganization:
- Established the Office of Product Evaluation and Quality (OPEQ) – combined 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 focused on a Total Product Lifecycle approach to medical device oversight.
- Established the Office of Policy – has two teams, the Guidance, Legislation and Special Projects Team and the Regulatory Documents and Special Projects Team. There are no changes in CDRH Policy functions.
- Established the Office of Strategic Partnerships and Technological Innovation – combined the Science & Strategic Partnerships, Digital Health, Standards, Health Informatics and Innovation teams. There are no changes in functions within the different teams.
- Realigned Management Services within the Center – ensuring administrative functions in CDRH are optimally aligned, structured, and deliver excellent service.
- Streamlined the Center's Communication Function – combined the internal and external communication functions, including CDRH ExecSec and Speaker Liaison, into the renamed Division of Communication in the Office of Communication and Education, and created an Internal Communication Branch.
The reorganization did impact some points of contact within CDRH. Changes to contact information are available in CDRH's Management Directory and communicated through the review offices.
CDRH's external stakeholders should continue to communicate with their current contacts in CDRH or use the CDRH Management Directory to find the best Center contact for a specific issue. For example, sponsors who are currently interacting with CDRH reviewers on submissions should continue to work with those same individuals.
If you have general questions about the CDRH reorganization, contact the Division of Industry and Consumer Education.