Guidance Documents (Medical Devices and Radiation-Emitting Products) > Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices

Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices

Document issued on: July 29, 2010

For questions regarding this document, contact CAPT Victoria Hampshire, VMD, Office of Device Evaluation, at 301-796-6395 or victoria.hampshire@fda.hhs.gov.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Division of Cardiovascular Devices
Office of Device Evaluation

Contains Nonbinding Recommendations

Preface

Public Comment

You may submit written comments and suggestions 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. Submit electronic comments to www.regulations.gov.

When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.

TABLE OF CONTENTS

I. Introduction

II. Scope

III. Overview

IV. Elements of the Animal Study

A. Rationale for Selecting Animal Models

B. Study Assurances

C. Study Objectives

1. Performance and Handling.

2. Device Safety

a. Mortality and Morbidity

b. Vascular Safety

c. Downstream and Systemic Effects

D. Study Schedule

E. Characterization of Test and Control Articles

F. Accessory Devices and Equipment

G. Test System

V. Personnel

VI. Facilities

A. Environment

B. Animal Groupings

C. Primary and Secondary Enclosures

D. Transport Systems

VII. Study Methods and Conduct

A. Research Controls

B. Study Equipment

C. Animal Identification

D. Animal Quarantine and Conditioning

E. Animal Allocation to Experimental Grouping

F. Food, Water and Basic Husbandry

G. Periods of Observation

1. Acute Studies

2. Chronic Studies

a. Post-Operative Period

b. Interim Periods of Observation

c. Terminal Study Period

d. Necropsy and Post-Mortem Evaluation

H. Post-Mortem Imaging and Assessment Methods

1. Explant Radiography

2. Scanning Electron Microscopy (SEM)

3. Histomorphometric Analysis

4. Local and Downstream Tissue Assessment

VIII. Records and Reports

IX. Preparation of Regulatory Submissions

Appendix A: List of Common Acronyms For Animal Studies

Appendix B: Sample Decision Tree for Animal Studies in the Cardiovascular System

Appendix C: Recommended Animal Study Research Controls to Consider

Appendix D: Sample Organization of Animal Study Test Reports

Appendix E: Tabulated Summary of Relevant Federal Regulations

Bibliography of Manuals and Publications

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Guidance Documents (Medical Devices and Radiation-Emitting Products) > Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices