Devices

Guidance on Medical Device Study Adaptive Designs

FDA has issued a guidance, Adaptive Designs for Medical Device Clinical Studies, to give sponsors suggestions on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. The document defines an adaptive design for a medical device clinical study as a clinical study design that allows for prospectively planned modifications based on accumulating study data without undermining the study’s integrity and validity. When properly implemented, it says, adaptive designs can reduce resource requirements, decrease time to study completion, and/or increase the chance of study success.

The guidance is applicable to PMA, 510(k), de novo, HDE, and IDE submissions. FDA says that it can be applied throughout the development program of a medical device, from feasibility studies to pivotal clinical studies. It does not apply to clinical studies of combination products or to co-development of a drug product with an unapproved/uncleared diagnostic test, although the underlying principles may be applicable to such studies.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome