- November 01, 2018
CDRH staff have tried to apply a total product lifecycle (TPLC) approach to regulatory decision-making, however, a major barrier has been the existing silos of functions, on the pre- and post-market side within the center’s offices, CDRH Director Jeffrey Shuren said at the 2018 FDA/Xavier Medcon conference in Cincinnati in May.
By folding four offices into one, the envisioned Office of Product Evaluation and Quality (OPEQ) is designed to account for the entirety of a product’s evolution. This in turn will allow CDRH staff to have “more organic connections and information-sharing,” as well as streamlined decision-making and collective processes, according to Shuren.
CDRH’s Office of Compliance (OC), Office of Surveillance and Biometrics (OSB), Office of Device Evaluation (ODE) and Office of In Vitro Diagnostics and Radiological Health (OIR) will be primarily impacted throughout the reorganization process.
FDA employees at OC, OSB and ODE will be grouped into six product-specific teams, though nine teams will comprise the OPEQ Immediate Office, including the OIR team. “We’re taking technologies that we put into different offices and moving away from a branch structure to instead have teams focused on a specific set of technologies,” Shuren said. The teams will address “all the various decisions and activities that apply across the TPLC,” such as premarket reviews, postmarket surveillance, compliance and quality.
An Office of Regulatory Programs and an Office of Clinical Evidence & Analysis will be established under OPEQ as well.
The graphic below provides a snapshot of how OPEQ will be structured.
Shuren highlighted the potential of a new Office of Clinical Evidence & Analysis to bring together experience and expertise from clinical trials, with epidemiologists involved in real-world evidence and statisticians to help ensure sufficient relevance and reliability of clinical evidence.
The creation of OPEQ also feeds into one of the three “strategic priorities” set forth in a three-year roadmap leading up to 31 December 2020 — to achieve an agency staff engagement level of at least 80%. According to Shuren, the current employee engagement level is at a mere 3%.
The roadmap — revealed earlier this year, with the other two priorities involving simplicity and collaborative communities — banks on a single measure: having 50% of manufacturers of innovative technologies come to the US market first or in parallel with others.
However, the 22-page report also points to an additional success factor for the center’s transformation: To “continually ensure that barriers and silos become a thing of the past.” And the new teams are intended to address this through greater engagement.
FDA has been investing in its employees “for a long time”; however, there is room for improvement on this front to offer “more opportunities for professional growth and personal development and assuring that we’re providing them with a reasonable work-life balance,” Shuren said.
The Center intends to implement the new organizational structure by the end of this year, CDRH Chief Medical Officer William Maisel told RAPS Regulatory Focus. CDRH does not expect to face any hurdles in first receiving approvals from the Department of Health and Human Services and Congress.
A main takeaway for firms is to expect improved efficiency in CDRH’s customer service as each of the new offices will be designed as a “one-stop shop” for all their product needs, said Maisel, who also serves as the ODE director. Firms will also be able to foster relationships with the familiar faces at the center firms have already engaged with more effortlessly than in the past.
CDRH’s Office of the Center Director (OCD), Office of Communication and Education (OCE), Office of Science and Engineering Laboratories (OSEL) and Office of Management (OM) will remain unchanged, Maisel said.
However, management structure in the OPEQ Immediate Office will take a more team-based approach in overseeing the new offices and developing new high-level policies and procedures while the newly established Office of Regulatory Programs will focus on existing ones, Maisel noted.
He echoed Shuren’s case for the Office of Clinical Evidence & Analysis from which agency staff intends to strengthen its understanding on the products they review and regulate.
The graphic below names the directors that will head the future OPEQ offices focused on a total of seven product types.
REFERENCE: RAPS – Regulatory Focus; 02 MAY 2018; Ana Mulero