A new Software-as-a-Service tool that in less than 20 minutes provides crucial information needed for determining the FDA classification and regulatory pathway for medical device technology has just been released by e-Zassi, and is being offered with an introductory discount in partnership with 2Market Information Inc., the parent company of Tech Transfer E-News.
Within minutes, the US FDA Regulatory Calculator provides users with a potential FDA predicate, regulation product code, and the classification and regulatory pathway associated with a medical technology. With this new tool, you’ll save hours in initial research and eliminate the need for outside experts early in the process. Understanding the classification and regulatory pathway of new medical device technologies is critical to early business planning, market assessment, and understanding of FDA requirements. Typically, this takes in-house staff or outside consultants many research hours, can delay product development, and eats up additional time and money. The new tool puts regulatory pathway information at your fingertips early in the device development process, minimizing the potential for miscalculations with due diligence and helping to guide your commercialization and clinical trial strategy. For complete details, and to receive a $125 discount (E-News readers pay only $375), CLICK HERE.