Have you heard about the FDA's Center for Devices and Radiological Health (CDRH) Pathway to Innovation? Originally the pathway’s goal was to aid ground-breaking products reach patients in a safe, and time efficient manner.
Earlier this month the second version of the pathway was released. Innovation Pathway 2.0 “offers new and modified tools and methods to deepen 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.” According to the website, the two main goals of Innovation Pathway 2.0:
- The FDA's approval decisions hinge on analysis of benefit and risk, and Innovation Pathway 2.0 incorporates new methods for agency reviewers to analyze the potential benefit and risk of a devices, including:
- A decision support tool which is a semi-quantitative way to streamline decision-making by focusing on the most important issues.
- Incorporation of a Benefit-Risk guidance for including patient perspective, such as patient tolerance for risk, how the disease the device is intended to treat or diagnose affects the patient that have it, the ability to mitigate risk to the patient, availability of alternative treatments, and the value the patient places on treatment
- The FDA has always worked interactively with sponsors; however, the Innovation Pathway amps up that collaboration and increases the level of interaction throughout the device's development through tools such as:
- Each device team of reviewers and sponsors on the innovation pathway will be assigned an FDA Case Manager
- FDA will produce a memo within 120 days of engagement that identifies key scientific and regulatory requirements, outlines a shared understanding of success and maps out a customized and more predictable regulatory pathway.
- IT Tools for Collaboration by setting up a secure online conference center for each device team on the Innovation Pathway allowing team members to easily interact.
- Establishing a Network of Experts of outside scientists, clinicians and engineers who will provide the Center for Devices and Radiological Health (CDRH) staff with rapid access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise within the CDRH.
The FDA has established a strong foundation for this new initiative. In fact, a Collaboration Phase Playbook has been developed which includes case studies and guiding principles.
Do you have any thoughts on the FDA’s new pathway? Do you believe this will “transform the experience for innovators working with FDA and for FDA working with innovators,” as the FDA hopes? Let us know what you think.
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