Streamlining The Generic Combination Device Design Assessment Process

Generic drug-device combination products (g-DDCPs) are crucial for making medications more affordable and accessible. However, their regulatory approval process is complex and expensive. Battelle, with FDA support, developed a six-phase alternative assessment method aimed at simplifying this process while ensuring safety, effectiveness, and substitutability.

This approach reduces reliance on costly comparative use human factors (cuHF) studies and instead systematically evaluates device differences in form, function, user interface, and labeling. The process includes risk management, user interface design assessment, comparative risk evaluation, validation, residual risk assessment, and a structured final report. By shifting the focus from replication to substitution, manufacturers can improve designs, enhance usability, and address safety concerns found in reference-listed drugs (RLDs).

Unlike traditional approval pathways, this framework enables faster development and regulatory compliance without compromising user safety. It proposes alternative validation methods, such as bridging studies and human factors validation testing, which are more cost-effective than cuHF studies. These methods ensure that g-DDCPs can be used by patients experienced with RLDs without requiring additional training.

By streamlining the design assessment process, this method not only reduces regulatory burdens but also encourages innovation in drug delivery devices. If widely adopted, it could lead to improved patient outcomes, lower healthcare costs, and greater market competition for affordable medications.