May 13, 2019 In March, the FDA's Center for Devices and Radiological Health's (CDRH) announced a major reorganization integrating CDRH's premarket and postmarket program functions along product lines. According to the Agency’s outline, the reorganization will empower experts to optimize decision-making across the product life cycle, consolidating many of the current aspects of product review, quality, surveillance, and enforcement into a new, team-based approach
The reorganization is expected to be completed by September. Earlier this month, the CDRH announced the Office of Product Evaluation and Quality (OPEQ), combining former offices of Compliance, Device Evaluation, Surveillance and Biometrics, and In Vitro Diagnostics and Radiological Health into one super office.
“This type of structure consolidates and integrates many of the current aspects of product review, quality, surveillance and enforcement into a new, team-based approach,” CDRH writes. “Rather than assessing a device only at one point in time—for instance, to evaluate whether a device meets the standard for approval, or to evaluate post-market data involving a device safety signal—reviewers, compliance officers and other experts would work in teams responsible for device oversight throughout the product's development and commercialization.”
Of course those aren’t the only changes at FDA. Last fall, Scott Gottlieb announced that the FDA is assisting Congress in crafting new legislation that will help shape a modern framework for accurate and safe diagnostics. In December, the Agency issued a draft guidance on developing and labeling in vitro companion diagnostic devices for oncology, and there are several draft guidances impacting diagnostics on the docket for 2019.
These changes are of major importance to the diagnostics community. A host of FDA staff will be on hand at the Next-Generation Dx Summit, August 20-22 in DC, sharing updates on changes at the Agency and perspectives on precision medicine in the future. –the Editors
Tim Stenzel, Director of the Office of In Vitro Diagnostics and Radiological Health, will give the plenary keynote presentation, focusing on FDA updates now and into the future.
Heike Sichtig, Principal Investigator and Team Lead, for Microbiology Devices within the Center for Devices (CDRH), FDA will lead a panel on commercialization and validation of NGS diagnostics.
Anand Pathak, Medical Officer, FDA, will discuss the implementation of immuno-oncology diagnostic tests in clinical trials, including understanding the regulatory implications of different approaches, validation of emerging pan-tumor CDx claims, and complementary diagnostics vs. companion diagnostics.
Pamela Gallagher, Scientific Reviewer at FDA, will explore the regulatory challenges and opportunities for companion and complementary diagnostics, discussing strategies for successful co-development of companion and complementary diagnostic devices and the FDA regulatory review process.
Zivana Tezak, Associate Director for Science and Technology, Personalized Medicine Staff, Office of in vitro Diagnostic Device Evaluation and Safety, FDA, joins a panel on somatic reference samples for NGS Dx.
Shyam Kalavar, Senior Scientific Reviewer, Molecular Pathology and Cytology Branch, FDA, explores FDA’s first authorization of a digital pathology whole slide imaging system for primary diagnosis in 2017, and explains the review process for a marketing application for this type of a device, and regulatory perspective on issues such as interoperability and artificial intelligence.