Implementing a Team Based Approach to Medical Device and Radiological Product Evaluation and Quality
Learn about our early successes in streamlining processes and more quickly addressing safety and other issues.
The FDA's Center for Devices and Radiological Health's (CDRH) is reorganizing to create an agile infrastructure that can adapt to future organizational, regulatory and scientific needs. This reorganization does not change the mission of CDRH or any MDUFA IV timelines.
Implementation of the reorganization will take a phased approach that began on March 18, 2019, and we expect to complete implementation by the end of September 2019. Updates on our progress will be posted on this web page periodically.
On This Page:
- Why Is CDRH Reorganizing?
- What Is the Benefit of the CDRH Reorganization?
- What Is the Timeline for Implementation of the CDRH reorganization?
- What Are the Changes to CDRH's Organizational Structure?
- Will My CDRH Points of Contact Change?
- Where Can I Send Questions?
- Additional Resources
Once fully implemented, the CDRH reorganization will generate efficiencies that will allow us to more fully realize the FDA and CDRH's public health mission and vision. 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.
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 allows employees to become specialized by function, it does 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) integrates 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 goal of the CDRH reorganization is to improve organizational efficiencies to better meet public health needs. Once fully implemented, CDRH's premarket and postmarket program functions will be integrated along product lines. 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. 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 would work in teams responsible for device oversight throughout the product's development and commercialization.
Implementation of the CDRH reorganization is taking a phased approach that began on March 18, 2019. Full implementation of the reorganization will be completed by September 30, 2019.
During implementation, each office within the current Center structure will undergo some change to better support and advance CDRH's public health mission and vision.
Current CDRH Structure
CDRH Structure After Full Implementation
Office of Product Evaluation and Quality (OPEQ)
Implementation of the Reorganization will:
- Establish the Office of Product Evaluation and Quality (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 into one super office focused on a Total Product Lifecycle approach to medical device oversight. (Completed May 1, 2019)
- Establish the Office of Policy – establishes the Office of Policy which will have 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. (Completed March 18, 2019)
- Establish the Office of Strategic Partnerships and Technological Innovation – combines the Science & Strategic Partnerships, Digital Health, Standards, Health Informatics and Innovation teams. There are no changes in functions within the different teams. (Completed March 18, 2019)
- Realign Management Services within the Center – ensures administrative functions in CDRH are optimally aligned, structured, and deliver excellent service.
- Streamline the Center's Communication Function – combines 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 creates an Internal Communication Branch.
Once implementation is complete at the end of September 2019, some points of contact within CDRH will change. As implementation occurs, changes to contact information will be updated on CDRH's 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 implementation of the CDRH reorganization, contact the Division of Industry and Consumer Education by phone (800-638-2041 or 301-796-7100) or email (firstname.lastname@example.org).