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US FDA Touts Big Improvements In Product Review Process: Report

US FDA Touts Big Improvements In Product Review Process: Report

Source : Medtech Insight

In a new report the US Food and Drug Administration says it has met or exceeded all components of its 2018-2020 strategic priorities, including simplifying processes critical to product review.

The agency’s Center for Devices and Radiological Health (CDRH) in early 2018 outlined a number of strategic priorities to improve its internal operations, focusing on employee engagement, opportunity, and success; simplicity; and collaborative communities. To follow up on the plan the agency published a report on 12 August that says it met those objectives and, in some cases, exceeded them. ("US FDAs Shuren Device Center Will Roll Out New Strategic Priorities In 2022" "Medtech Insight" )

The device center had set a goal to streamline at least 80% of its core processes by last year that would be a significant improvement for product applications, but the report says the device center has leaned 86% of those processes.

“The CDRH Process Improvement Program, launched in 2019, uses Lean Six Sigma as its foundational methodology and works with CDRH staff to improve and simplify processes,” the FDA said. “Since 2019, the program has engaged in over 48 improvement projects, leaning 44 out of 51 identified ‘core’ processes.”

More specifically, the device center says a team tasked with harmonizing its de novo review process was able to remove 20% of its administrative steps. Similarly, the team was able to simplify the Clinical Laboratory Improvements Amendments (CLIA) waiver process by reducing the number of reviews of laboratory developed tests (LDT) that took longer than 30 days, to 6%.

In addition to simplifying its core processes, the CDRH has been able to increase staff engagement to 81%, which includes engaging with workers on career development, better communication, more opportunities for feedback and improving work-life balance.

The center has also invested in developing a wellness center to help boost staff morale and quality of life, and a Digital Transformation Initiative that’s meant to provide digital tools to streamline their work.

The CDRH has long raised concerns it is unable to pay workers competitively compared to the private sector and with the added pressure of the COVID-19 pandemic, its leadership has said it risks losing valued staff due to the added workload. ("A Chat With Jeff Shuren FDA Device Center Chief Worries About Agency Staffing Talks MDUFA V Pandemic More" "Medtech Insight" )

“Engaged employees are the most productive, creative, loyal, and motivated; they are less likely to leave and more committed to the mission and vision,” the report says. “However, engagement requires work-life balance, open dialogue, and opportunities to succeed.”

Finally, the CDRH has also been engaging with stakeholders through various collaborative communities over the past few years. The agency has repeatedly touted the importance of working with key players in the medical device ecosystem to find goals to shared problems.

Its objective was to engage in at least 10 collaborative communities by the end of 2020, but as of now the CDRH is engaged in 12. ("MDIC Announces Pathology Collaborative Community With FDA Involvement" "Medtech Insight" )

By Ferdous Al-Faruque