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FDA Final Guidance Document: “Adaptive Designs for Medical Device Clinical Studies”

Today, the FDA published the Adaptive Designs for Medical Device Clinical Studies Final Guidance.  It provides clarity on how to plan and implement adaptive designs for clinical studies used in medical device development.  This final guidance applies to premarket medical device submissions including premarket approval applications (PMA), premarket notification (510(k)) submissions, de novo submissions, humanitarian device exemption (HDE) applications, and investigational device exemption (IDE) submissions.

Adaptive design allows for prospectively 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.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov1-800-638-2041, or 301-796-7100.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health