Shuren Outlines Reorganization for Device Activities
CDRH is proposing a complete overhaul of its medical device review, safety surveillance and compliance structure to move to a more total product lifecycle (TPLC) approach to its decision making. Speaking at the Food and Drug Law Institute’s annual meeting in Washington, DC 5/3, CDRH director Jeff Shuren said that currently one of the challenges the Center faces is that the activities in the TPLC are siloed in different offices and that creates difficulties with “sharing information and ensuring we are making the most well-informed decision making. There is a lot of extra layers of process and hierarchy we have to deal with. The idea is to take the Office of Device Evaluation, Office of Compliance, Office of Surveillance and Biometrics, and Office of In Vitro Diagnostics and Radiological Health and put them all together in a super collider and what comes out in the end is a new office structure.” The proposed name of the new structure is the Office of Product Evaluation and Quality.
Currently, the proposed reorganization is going through clearance process. Shuren said it will lead to:
- Organic connections within the organization
- Streamlined decisions and processes
- Shared priorities
- Better customer service
- Professional growth for staff
Shuren told FDLI that management under the new structure would be “flattened” with branches being eliminated and that this will move over to a “true team management approach... Within the offices, teams will be responsible for a set of technologies for all decisions around that technology across the TPLC, so that the team is responsible for decisions on premarket, post-market surveillance, compliance and enforcement and quality all working together. The would be no more dealing with separate offices on these issues.”
To highlight one office under the structure, Shuren said the proposed Office of Clinical Evidence and Analysis would bring together the clinical trials program staff and epidemiologists who deal with real world evidence. “This office would move away from the concepts of traditional clinical trials and real world evidence and would just think about clinical evidence and focus on what really matters, which is relevant and sufficiently reliable information for decisions it needs to make,” he said.
Shuren’s FDLI address also discussed upcoming efforts under the reauthorized device user fee program. For example, at the end of last year, CDRH issued proposed criteria for those devices eligible for voluntary malfunction summary reporting. “Over the summer, we will put out final criteria as well as a list of devices eligible for summary reporting,” He said. Another proposal moving forward is a 10-day call option for sponsors who receive an “additional information” request letter after a 510(k) review. “So if you get an additional information letter, then you have an opportunity to get on a call with the review team within 10 days of us issuing the letter,” he said. “The purpose of that is not debating the deficiency, rather to hear from the team to explain what they are really looking for and why are they looking for it so that there is greater clarity. Sometimes we are not as clear as we could be and we want sponsors to know exactly what to do. So after the call, companies can disagree and have an opportunity to engage with senior management to try to resolve it.”