This document is intended
- To provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and FDA staff who review those submissions.
- To describe the different clinical study designs that may be appropriate to support a device premarket submission, or
- To define how a sponsor should decide which pivotal clinical study design should be used to support a submission for a particular device.
- To describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements.
- This guidance is not intended to provide a comprehensive tutorial on the best clinical and statistical practices for investigational medical device studies.
- This guidance is intended to complement other existing guidance, and is not intended to replace the policies described in other guidance.
Medical devices can undergo three general stages of clinical development. These stages are extremely dependent on each other and doing a thorough evaluation in one stage can make the next stage much more straightforward. To begin, medical devices undergo an exploratory clinical stage. In this stage, the limitations and advantages of the medical device are evaluated. This stage includes first-in-human studies and feasibility studies. The next stage, the pivotal stage, is used to develop the information necessary to evaluate the safety and effectiveness of the device for the identified intended use. It usually consists of one or more pivotal studies. Finally, devices undergo a post market stage which can include an additional study or studies for better understanding of device safety, such as rare adverse events and long-term effectiveness. This guidance provides information on design issues related to pivotal clinical investigations and does not address the other stages in any detail.
Types of Studies Addressed in this Guidance
Due to the range of intended uses and risks associated with medical devices and constraints in executing clinical studies, this guidance treats premarket clinical studies in a general manner. It frames FDA’s recommendations in terms of two broad categories of medical devices:
- Therapeutic and aesthetic devices
- Diagnostic devices
From this guidance, device developers can gain insight about important pivotal study design issues for devices in each of these categories.
This guidance also includes principles that are applicable to the device-specific issues for combination products defined under 21 CFR Part 3 (e.g., device-drug products; device-biologic products). However, drug-specific or biologic-specific issues that may also be relevant for a combination product are not described in this guidance.
Types of Studies Not Addressed in this Guidance
Although this guidance does not address the following kinds of studies, some principles discussed herein are applicable to many of them:
- Non-clinical studies (e.g., bench, animal or measurement studies and, for in vitro diagnostic devices, analytical validation studies);
- Studies intended to support Humanitarian Device Exemption (HDE) applications.
- Premarket feasibility clinical studies, or other premarket clinical studies that are not part of the pivotal stage;
- Studies to establish the clinical validity of companion diagnostic devices (i.e., in vitro diagnostic tests that provide essential information for the safe and effective use of a corresponding therapeutic product). Clinical development programs for companion diagnostic devices are typically part of the clinical development programs of the corresponding therapeutic products;
- Post market clinical studies. Though the need for post market clinical studies might arise from interpretation of premarket clinical results, post market studies do not drive the initial determination of safety and effectiveness, and their design is not addressed in this guidance. However, the principles discussed in this guidance may be useful in designing such studies;
- Studies of products regulated by CBER that require an Investigational New Drug application and Biologics License Application, such as donor screening tests, are not included in the scope of the guidance.
PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FR Doc No: 2011-20603
Or you can send your comments within 90 days at firstname.lastname@example.org and REF: Design Considerations for Pivotal Clinical Investigation.
For more information on this guidance you can go to the following link:http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM267831.pdf