A phased-in approach to reorganize the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration will begin Monday, with the new “super office” set to transform medical device reviews, oversight and enforcement via integration of a total product lifecycle (TPLC) approach.
CDRH Director Jeff Shuren first discussed
the reorganization plans in 2017. Certain details, including the overall structure once fully implemented, the name of the new “super office” and the intended benefits, trickled
out during 2018 conferences. But most were unknown until Wednesday.
The center sent a notice Wednesday to provide additional clarifications on the purposes of reorganizing the current structure, the benefits in terms of public health and the specific changes to the current CDRH organizational structure. As far as the official timeline for implementation, CDRH seeks to complete the reorganization by 30 September.
At the center of the reorganization plans lies the establishment of the “super office,” deemed the Office of Product Evaluation and Quality (OPEQ), which is one of three new offices under the restructuring plans. The OPEQ Immediate Office will be comprised of nine offices, including six product-specific teams, once fully implemented. The envisioned OPEQ structure is displayed in the graphic below.
“Once fully implemented, CDRH's premarket and postmarket program functions will be integrated along product lines,” CDRH said in its new webpage
on its reorganization plans. “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.”
In addition to OPEQ, reorganizing CDRH will also involve establishing the new Office of Policy and the Office of Strategic Partnerships and Technological Innovation. The latter office underscores CDRH’s efforts to foster innovation, including in the digital health space through the work-in-progress PreCertification program.
The timelines for implementation will vary by office. The result will be a total of six offices under the Office of the Center Director (OCD) compared to six in the current CDRH structure. This increases to a total of 16 offices when including OPEQ's nine offices. OCD will be retained and so will the Office of Management, the Office of Science Engineering Laboratories and the Office of Communication and Education (OCE). OCE, however, will be revamped to combine both internal and external communication functions into the renamed Division of Communication and create an Internal Communication Branch as part of the restructuring process.
The center noted that “each office within the current center structure will undergo some change to better support and advance CDRH's public health mission and vision” during the implementation phase. Some points of contact will change post-implementation, though changes to contact information will be updated throughout the implementation process in CDRH's management directory. "Sponsors who are currently interacting with CDRH reviewers on submissions should continue to work with those same individuals," CDRH clarified.
A pilot was launched last June across three offices to test and evaluate the internal shift toward the team-based, TPLC approach. CDRH had initially planned on completing implementation of the reorganization by the end of 2018, CDRH chief medical officer William Maisel previously told Focus
. The plans were subject to approvals from Congress as well as the US Department of Health and Human Services.
The graphic below provides a snapshot of the new CDRH structure, once fully implemented.