Announcing Draft Guidance on Adaptive Design for Medical Device Clinical Studies

Today the FDA posted draft guidance on Adaptive Design for Medical Device Clinical Studies. When finalized, this guidance will provide clarity on the design and use of adaptive designs for clinical studies of medical devices.

Adaptive design allows for planned modifications to a clinical study based on accumulating data, while maintaining the trial’s integrity and validity. When properly implemented, adaptive design can reduce resource requirements and/or increase the chance of study success.

We are releasing this guidance to further encourage companies to consider the use of adaptive design in their clinical trials. It is part of the FDA’s on-going efforts to improve access to new devices by strengthening and streamlining the clinical trial enterprise.

We welcome your comments and suggestions regarding this draft guidance. The comment period will be open for 90 days.

Thank you.

Food and Drug Administration
Center for Devices and Radiological Health