On April 9, 2012, the FDA’s Center for Devices and Radiological Health (CDRH) announced additional details of its work on a process where innovators and FDA staff map out the future regulatory pathway for a product called “Innovation Pathway 2.0.” According to the agency, the second version of the pathway offers new and modified tools and methods for collaboration between the FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory process more efficient and timely. The overarching goal is to shorten the overall time and cost it takes for the development, assessment and review of medical devices, and to improve how FDA staff and innovators work together.
An interesting development is the test of a small-scale decision support tool for FDA reviewers to use in evaluating first-in-human (FIH) clinical trials as a semi-quantitative process to streamline decision-making. The FDA noted that the tool could be useful at many points during the device review process, but chose to apply it first to FIH decisions because these decisions influence many later outcomes. For example, the decision to allow FIH clinical trials is critical to the development of new medical technology, yet the decision to allow a device to be tested in humans for the first time — with relatively little information and much uncertainty — is one of the toughest the agency makes.
The FIH tool would provide information on whether a medical device can proceed to early feasibility studies or whether further preclinical testing is needed to ensure safety and effectiveness. The tool’s framework is based on the draft guidance, “Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies1.”
The FDA also published a ”Collaboration Phase Playbook” to provide guiding principles and case examples on strengthening the relationship between the agency and industry. The agency noted that this included creating a shared understanding of product success, applying best practices in framing benefits and risks, and striving for greater transparency by quickly delivering guidance to industry.