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# Guidance on Device Adaptive Clinical Study Designs
- URL: https://www.fdaweb.com/guidance-on-device-adaptive-clinical-study-designs/
- Published: 2016-07-27T12:00:00.000Z
- Updated: 2026-09-14T21:18:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136307

*Federal Register* Notice: FDA is making available a guidance entitled *Adaptive Designs for Medical Device Clinical Studies*. It provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is a design that allows for prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity. Adaptive designs can reduce resource requirements and/or increase the chance of study success. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM446729?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-07-27/pdf/2016-17651.pdf?ref=fdaweb.com)