The U.S. FDA’s Center for Devices and Radiological Health (CDRH) has opened its new office, the Office of Product Evaluation and Quality (OPEQ), which will be responsible for streamlining the process of and helping customers get answers about to premarket review, post-market surveillance, and compliance that strengthens its focus on safety and effectiveness throughout the entire lifecycle of medical devices.
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, such as robotic surgical systems and mobile medical applications, are and remain safe and effective. After all, modern medical devices require an agile organization that can respond quickly to real-world safety signals and new evolving technologies, FDA officials say.
For the past year, the 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, according to the FDA. (For example, a team within OPEQ working on blood pressure and flow devices became aware of a malfunction associated with a manufacturer’s hemodynamic monitoring system.) 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.
When CDRH released its 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, according to the FDA. 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, FDA officials say.
“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,” explains William Maisel, MD, MPH, director, Office of Product Evaluation and Quality, and Jeff Shuren, MD, JD, director of the CDRH. “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.”