Sponsored Presentations: FDA first, CE later. Clinical and regulatory strategy trends

Description:
The requirements for clinical data, specifically clinical study data, needed to obtain device market approval continue to increase over time based on stricter regulatory requirements, and also new insights from the use of medical devices. With clinical studies being the costliest part of device development, it is key to design a clinical study strategy that is as efficient as possible. In addition, a clinical study strategy that combines studies for multiple geographies may require fewer subjects to be enrolled in total. This is not only advantageous from a cost perspective, but may also help with enrolment timelines, especially with hospitals still coping with the (results of the) pandemic.
This session will discuss how to create a proper regulatory-clinical strategy using regulatory requirements, requirements from standards and guidance documents, and a literature review of the standard of care covering all relevant geographies. The session will also address how endpoints, sample size, and follow-up can be derived from the regulatory-clinical strategy and how this can be used for an efficient clinical study design. Lastly, the session will cover the application of this concept for novel devices.