Guidance Documents (Medical Devices and Radiation-Emitting Products) > Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices

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Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices

¹This guidance document is being distributed for comment purposes only.
Document issued on: August 15, 2011

You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document contact Gregory Campbell, PhD at (301) 796-5750 or by email at greg.campbell@fda.hhs.gov, if desired.
For questions regarding this document, contact CBER’s Office of Communication, Outreach and Development at 1-800-835-4709 or 301-827-1800.

U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Surveillance and Biometrics Office of Device Evaluation Office of In Vitro Diagnostics Center for Biologic Evaluation and Research

Preface

Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number 1776 to identify the guidance you are requesting.
Additional copies of this guidance document are also available from:
Center for Biologics Evaluation and Research (CBER),
Office of Communication, Outreach and Development (HFM-40),
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448,
or by calling 1-800-835-4709 or 301-827-1800, or email ocod@fda.hhs.gov, or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm².

Table of Contents

1. Introduction
2. Scope
   • 2.1 Types of Studies Addressed in this Guidance
   • 2.2 Types of Studies Not Addressed in this Guidance
3. Regulatory Framework for Level of Evidence and Study Design
   • 3.1 The Statutory Standard for Approval of a PMA : Reasonable Assurance of Safety and Effectiveness
   • 3.2 Valid Scientific Evidence
   • 3.3 Risk-Benefit Assessment
   • 3.4 Clinical Study Level of Evidence and Regulation
   • 3.5 The Least Burdensome Concept and Principles of Study Design
4. Types of Medical Devices
   • 4.1 Types of Devices Based on Intended Use
   • 4.2 Special Considerations for Clinical Studies of Devices
5. The Importance of Exploratory Studies in Pivotal Study Design
6. Some Principles for the Choice of Clinical Study Design
   • 6.1 Types of Studies
   • 6.2 General Considerations: Bias and Variability in Device Performance
   • 6.3 Study Objectives
   • 6.4 Subject Selection
   • 6.6 Site Selection
   • 6.7 Comparative Study Designs
7. Clinical Outcome Studies
   • 7.1 Endpoints in Clinical Studies
   • 7.2 Intervention Assignment (Randomization) for Clinical Outcome Studies
   • 7.3 Masking (Blinding)
   • 7.4 Controls in Comparative Clinical Outcome Studies
   • 7.5 Placebo Effect and Other Phenomenon
   • 7.6 Non-Comparative Clinical Outcome Studies
   • 7.7 Diagnostic Clinical Outcome Studies
   • 7.8 Advantages and Disadvantages of Some Clinical Outcome Studies
   • 7.9 Some Regulatory Considerations
8. Diagnostic Clinical Performance Studies
   • 8.1 Consideration of Intended Use
   • 8.2 True Status of the Target Condition
   • 8.3 Study Population for Evaluation of Diagnostic Performance
   • 8.4 Study Planning, Subject Selection and Specimen Collection
   • 8.5 Diagnostic Clinical Performance Comparison Studies
   • 8.6 Masking (Blinding) in Diagnostic Performance Studies
   • 8.7 Skill and Behavior of Persons Interacting with the Device (Total Test Concept)
   • 8.8 Other Sources of Bias
9. Sustaining the Level of Evidence of Clinical Studies
   • 9.1 Handling Clinical Data
   • 9.2 Study Conduct
   • 9.3 Study Analysis
   • 9.4 Anticipating Changes to the Pivotal Study
10. The Protocol
11. Glossary

Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff

Design Considerations for Pivotal Clinical Investigations for Medical Devices

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.