Medical Devices (includes In Vitro Diagnostics)
Strategic
Mac McKeen, MBA, RAC
Fellow, Regulatory Science
Boston Scientific Corporation
Marjorie Shulman
ORP, OPEQ, CDRH
FDA
.png "Natalia Remmel, PhD photo")
Natalia Remmel, PhD
Director of Quality and Regulatory Affairs
Proscia, Inc
FDA has recently announced modernization of the 510(k) clearance process and proposed improvements to the direct De Novo process, offering attractive risk-based regulatory approaches to bringing innovative new devices to market. Changes to the 510(k) process established in 1976, including a controversial 10-year limit on predicates, and an accelerated process are being considered. The De Novo process was originally introduced in 1997 and has been modified under the FDA Safety and Innovation Act (FDASIA) as well as the 21st Century Cures Act, yet surprisingly little transparency on the process has existed. On December 5, 2018, the FDA published a proposed rule to establish regulations for the De Novo classification process. These landmark proposed ruling by FDA are positioned to bring significant improvements in transparency and efficiency of new device submissions in the US, while stimulating innovation in innovative markets like machine learning and artificial intelligence software, additive manufacturing (3D printing), diagnostics, among others. As the number and complexity of innovative device continues to expand at a rapid pace, this session is designed to overview the regulatory pathways available for innovative devices in context of practical case studies across therapeutic areas and technology segments. In addition, we will cover potential execution strategies to accelerate clinical trial processes, from planning to monitoring and eventual reporting. Led by a group of industry experts, these topics will position regulatory affairs professionals to offer strategic and targeted solutions for innovative products.