By: William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality, and Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health
Protecting patient health is the FDA’s highest priority. This commitment to improving the health and the quality of life of patients is the leading force behind the operational transformation and the approach to work within the FDA’s Center for Devices and Radiological Health (CDRH). By transforming our organization’s structure and processes, the Center will be even better positioned to fulfill its mission of ensuring that patients and health care providers have continued access to safe, effective, and high-quality medical devices.
Last month, CDRH announced one of the key steps in this transformation is a transition to a more holistic, team-based approach to premarket review, postmarket surveillance, and compliance that strengthens its focus on safety and effectiveness throughout the entire lifecycle of medical devices. And it makes it easier for CDRH customers to get the answers and support they need by having one team address all issues rather than having to navigate multiple offices. Today, CDRH is taking that step by operationalizing its new office responsible for these functions, the Office of Product Evaluation and Quality (OPEQ).
Consider this: many aspects of the Center’s organizational structure date back to 1976, when Congress first enacted the Medical Device Amendments. Such a structure is no longer adequate to optimally ensure that complex, 21st century devices, like robotic surgical systems and mobile medical applications, are and remain safe and effective. Modern medical devices require an innovative and agile organization that can respond quickly to real-world safety signals and new evolving technologies.
For the past year, CDRH has been testing and refining this modern approach as the Office of Product Evaluation and Quality (OPEQ) Pilot, which has gleaned significant improvements in its capabilities to streamline processes and more quickly address safety and other issues.
Identifying, Resolving, and Communicating Safety Issues — Faster and Better
During the piloting of OPEQ in August 2018, a manufacturer of an implantable eye micro stent indicated for use in conjunction with cataract surgery to reduce intraocular pressure in adult patients with certain types of glaucoma contacted the FDA about withdrawing the device from the market. The decision to immediately withdraw the device had been driven by data from one of two continuation studies ordered by the FDA as a condition of approval. According to the long-term data, significantly more users of the device showed a loss of corneal endothelial cells (as compared to a control group), a condition that leads to loss or reduction in vision. In the new OPEQ structure, pre- and post-market teams work together within the same team, enabling them to work quickly and efficiently with the manufacturer to evaluate and compare data from the initial pre-approval and post approval studies.
CDRH quickly issued a safety communication to inform patients and eye care providers of the newly identified risks associated with the implant. Soon thereafter, the FDA identified this as a Class I recall and the safety communication was updated with additional details, including revised recommendations for eye care providers. FDA staff followed up to ensure that the manufacturer suspended all current studies involving its device. The swift alert enabled patients and eye care providers to speak about their treatment plans and helped prevent additional patients from receiving the device.
Another example from earlier this year involved a team within OPEQ working on Blood Pressure and Flow Devices that became aware of a malfunction associated with a manufacturer’s hemodynamic monitoring system. The new structure under which OPEQ operates strengthens our ability to collaborate. This enabled the team to gather device, clinical, and compliance specialists together quickly for consultation and, within a week, to interact with the manufacturer, resulting in the prompt submission of a Medical Device Correction and Removals Report (806 report) on the correction to the FDA. Through this work, the FDA was able to work with the manufacturer to take the appropriate regulatory action to help prevent the serious malfunction from continuing to occur.
Informing New Product Approvals with Latest Safety Data
Through the creation of OPEQ, a team’s discoveries about a device’s safety profile helps inform its concurrent or subsequent reviews of premarket submissions. For example, while a team for Circulatory Support Devices was reviewing a premarket submission for a significant change in labeling for a legally marketed life-sustaining cardiovascular device, it concurrently received a recall for the legally marketed device. Information about a malfunction in the recall helped inform the team’s understanding of the device’s safety profile. Ultimately, the decision was made to classify the recall as Class II. Additionally, the team required the device’s manufacturer to implement extensive safety measures for all devices in use until design changes were made to assure the reasonable safety of the device. Moving forward, OPEQ’s team will apply this greater understanding of the device’s safety profile in all subsequent premarket submissions. Swift implementation of these safety measures ensured that the serious malfunction would be addressed and helped to prevent any additional harm to patients.
Advancing Safer and More Effective Innovative Technologies
When CDRH released the Medical Device Safety Action Plan last year, one of its stated goals was to “Spur innovation towards safer medical devices.” The creation of OPEQ is already proving successful in meeting this goal. For instance, during the PMA review for a first-of-a-kind medical device, the lead reviewer learned of an inspection that might result in regulatory or administrative actions being recommended for a supplier associated with the device. Because the communication and collaboration among team members provided the lead reviewer with this important information early in the process, the OPEQ team was able to consider and recommend alternatives, including the suggestion to remove that supplier. This type of collaboration helps eliminate delays in getting innovative medical device technologies to the patients who need them.
Enhancing Evidence Generation Throughout the Total Product Life Cycle
Clinical evidence is generated throughout the total product life cycle of a medical device, from the safe initiation of a clinical trial, through the appropriate premarket pathway, in any FDA-mandated postmarket clinical study, and for all postmarket surveillance. In the past, separate offices led efforts to strengthen the clinical trial enterprise and to advance the use of real-world data. In OPEQ, we bring together previously separate efforts to assess clinical trial design, devise strategies for gathering real world evidence in high-quality registries, payer claims and electronic health records, and oversee the conduct of clinical trials to assure data integrity and human subject protection. Bringing together these many facets of science further strengthens clinical evidence generation and helps to assure reliance on the most robust clinical evidence available to inform regulatory decisions.
Fostering Employee Engagement, Opportunity, and Success
The new OPEQ also supports the CDRH Strategic Priorities for 2018-2020 goal to improve employee work life by reducing unnecessary burdens and creating opportunities for professional growth and personal development. Throughout the process of building OPEQ, CDRH staff were engaged and provided feedback about how OPEQ offers them opportunities to broaden their perspectives, expand their skills, engage in new cross-training opportunities, and contribute to new program areas.
The implementation of OPEQ is a significant reorganization for the FDA, better positioning CDRH to meet the agency’s public health mission and vision. This reorganization integrates CDRH’s premarket and postmarket program functions along product lines, allowing its experts to leverage their knowledge to optimize decision-making across the total product life cycle. Learn more about CDRH’s new Office of Product Evaluation and Quality on FDA.gov, or contact the CDRH Division of Industry and Education (DICE) at 1-800-638-2041 or by email at DICE@fda.hhs.gov.