The FDA Center for Device and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns the expertise into teams by product type and technology. Individuals from the evaluation and compliance groups for specific product types and technologies will now be on one team, creating a new review and inspection dynamic.
The proposed CDRH “Office of Product Evaluation and Quality” (OPEQ) will be comprised of several “Office of Health Technology” teams that will focus combined expertise from the evaluation, compliance, surveillance and radiological health offices in the technology-specific teams to streamline the performance of regulatory reviews and improve communications.
At a Xavier Health “Half Day with FDA, The Future: Alignment and Reliance” web conference on February 1, 2018, CDRH Office of Compliance Regulatory Affairs Deputy Director Captain Sean Boyd presented the reorganization plan and the reasons for proposing it. The plan has been submitted for agency review and is anticipated to be approved and implemented by the end of 2018.
In Boyd’s talk – “Total Product Lifecycle (TPLC) Realignment within CDRH” – he characterized the proposed reorganization as “a new way of doing business that allows us to better focus on the total product lifecycle of devices, manufacturers, and the medical device industry.”
He explained that the effort began a decade ago with CDRH’s Office of In vitro Diagnostics (OID), which became the Office of In vitro Diagnostics and Radiological Health (OIR) about five years ago, and where this business model is currently employed.[RELATED: Get a weekly synthesis of all GMP regulatory and enforcement developments — start your FREE trial of the GMP Regulatory Newsletter today.]
Breaking Down Silos
In the current CDRH structure, Boyd commented, “These large offices – which may be between 200 and 600 people – naturally create barriers within the Center that can hamper sharing information across the Center, and hamper making decisions that are informed by everything that we know in the timeline in which we would want to make those decisions.”
The offices impacted are the:
- Office of Device Evaluation (ODE)
- Office of Compliance (OC)
- Office of Surveillance and Biometrics
- Office of In-vitro Diagnostics and Radiological Health (OIR).
CDRH will be combining staff and managers from these offices as well as the functions that they perform into “an entirely new organization – a Super Office called OPEQ.”
The Offices of Science and Engineering Laboratories (OSEL), Communication and Education (OCE), and Management (OM) will not be impacted by the restructuring, “but will be impacted in terms of the connections that we need to maintain or refine across the new organization,” the CDRH official explained.
The intent is to “eliminate silo structures, bring people together so that they are aware of all the information the Center has, and enable us to make better decisions around the specific technologies that we review.”
New Offices of Health Technology Combine Expertise
Within OPEQ, there will be seven Offices of Health Technology (OHTs) “that are aligned in much the way that our pre-market divisions are organized in ODE today.” Each office will be responsible for pre-market review, compliance and enforcement, and surveillance functions for specific types of medical devices.
For example, Boyd explained, people who today do pre-market reviews on cardiovascular devices, people who do compliance and enforcement reviews related to cardiovascular devices, and people who do surveillance related to cardiovascular devices will all be combined into one OHT. Likewise for orthopedic and other device areas or groupings of device areas.
Within each OHT there will be further breakdowns along more specific technology lines.
In addition to the expertise in the various functions, the team may also include people who are familiar with all of those functions – for example, a generalized reviewer who can operate in all of those functional areas.
“Importantly,” Boyd stressed, “those teams are going to be sharing information and interacting with one another on a regular basis to share what they know about something they have seen – for example, in a pre-market file that is in-house, or in a recall or in an inspection report review, or something that they have seen in a series of adverse event reports that they have looked at, or another signal that they are looking at. People are then able to better communicate the things that they know that might inform questions that we ask during one of our reviews.”
Also, the information sharing “might inform a path that we take to either achieve compliance or interact with a firm to better understand a technology or what is going on with a manufacturing process. So having people who share that information and collaboratively work to reach those decisions, we think, is a better model.”
In addition to the OHTs, OPEQ will contain two offices in charge of management of the regulatory programs – the Office of Regulatory Programs (ORP), and the Office of Clinical Evidence and Analysis (OCEA). These offices will be responsible for the development of policies, programs, and processes that are implemented within the OHTs.
“One of the primary goals of these supporting organizations,” Boyd emphasized, “will be to define the policies and processes and deliver the tools and templates that promote consistent application of policy across the Center.” The intent is to make decisions that are founded on the regulations and requirements, and to ensure “that we are modifying our approaches appropriately and consistently across all of those offices.”
One Stop Shop Envisioned
Once the reorganization take place, Boyd does not envision any immediate effects to be observed. Over time, however, the vision is for the OHTs to provide a “one stop shop” for regulatory and compliance information for device manufacturers.
The combined expertise will be “all on one team, one division, or one office, which will be able to address whatever needs you have. Teams can paint the full picture of what is going on with a particular device or firm.” As a result, industry should experience “better, more streamlined interactions and better informed decisions or outcomes as a result of what we are doing.”
This will result from CDRH having a better understanding of firms’ operations and being more familiar with how the various organizations function – for example, “where you excel, where you are growing, and where there may be issues that we might need to work together to address.”
The one-stop shop will be enabled by the teams:
- Having improved knowledge of the technologies that firms are bringing to market
- Having a concentrated sets of individuals that are focused on particular subsets of that technology
- Understanding from a pre-market review aspect what development, design, performance evaluation and testing have been done
- Understanding some of the clinical assessments that have been done to show that the device is ready to come to market
Both Small and Large Firms Will Benefit
At the end of Captain Boyd’s presentation, Xavier Health Director and session moderator Marla Phillips commented, “I think what you described with the ‘one stop shop’ is fantastic, especially if you are a small company and you have one or two products, that are typically within the same type of technology category. You are going to get to know your team in CDRH very well, and have a great interaction.”
She also noted that “larger companies have multiple technologies, but often have teams within the company that are working based on specific types of technologies, so they will have a specific team that they are going to get to know well.”
Regarding larger companies with multiple technologies and thus interactions with multiple OHT teams, Phillips asked what will be in place to ensure that the various teams communicate with each other regarding the same company. “How will they have a wider company view when they are working in these more silo approaches?”
Boyd responded that there is a plan to have “‘communities of practice’ in place that are designed to ensure that we are taking a holistic approach across multiple OHTs – for example, for a specific area that might be related to pediatrics or women’s health or some other cross-cutting or common area that could affect a single manufacturer who is operating in different device areas.”
In addition, “we might have networks of individuals who work across multiple OHTs who are familiar with some of the larger manufacturers that work in different device technology areas who are routinely coming together to share what they know about a particular firm.”
He also noted that the Office of Regulatory Programs will have the responsibility “to look at data that we have [internally] or external sources of data to identify trends that we are seeing across multiple OHTs that might be industry wide. We will look for trends that we are seeing for a particular manufacturer that works across multiple technology areas and share that information with the OHTs so that we are making the connections that we need to in our interactions with that firm on multiple different fronts.”
Total Product Lifecycle Database is Available
CDRH has made available to the public a database with information on the medical devices it approves.
The CDRH Total Product Life Cycle (TPLC) database integrates premarket and post-market data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. The TPLC database is refreshed as each of the individual data sources is updated.
The TPLC database can be searched by device name or product code to receive a full report about a particular product line.
In its current form, the TPLC database provides data by product code (procode), or generic category of device, and not by individual submission or brand name. A list of information sources that feed into the database is available here.[NOTE: Never miss an important FDA update. Start your free trial of the GMP Regulatory Newsletter today.]