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Adaptive Designs for Medical Device Clinical Studies Guidance for Industry and Food and Drug Administration Staff July 2016

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

An adaptive design for a medical device clinical study is defined as a clinical study design that allows for prospectively planned modifications based on accumulating study data without undermining the study’s integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements, decrease time to study completion, and/or increase the chance of study success. This guidance provides sponsors and Food and Drug Administration (FDA) staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs.

This document addresses adaptive designs for medical device clinical studies and is applicable to premarket medical device submissions including Premarket Approval Applications (PMA), premarket notification (510(k)) submissions, de novo submissions (Evaluation of Automatic Class III Designation), Humanitarian Device Exemption (HDE) applications and Investigational Device Exemption (IDE) submissions. This guidance can be applied throughout the clinical development program of a medical device, from feasibility studies to pivotal clinical studies. This guidance does not apply to clinical studies of combination products or co-development of a pharmaceutical product with an unapproved/uncleared diagnostic test. However, the underlying principles may be applicable to such studies.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, a guidance document describes the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-1439.

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