Description
This guidance document provides the FDA’s recommendations on animal studies intended to evaluate medical devices intended for human use, when a suitable alternative to an animal study is not available. This guidance specifically applies to animal studies intended to assess device safety, which may include performance and handling, in premarket submissions to FDA. This guidance provides recommendations for various elements of animal studies, including the credentials for personnel conducting an animal study, and the study planning and conduct process, including but not limited to selecting an appropriate animal model, study monitoring, and study evaluation. This guidance also provides recommendations on testing facility selection, animal housing, records and reports, and how to prepare an animal study report for premarket submissions to FDA. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of medical device submissions.
Scope & Applicability
Product Classes
1Medical devices intended for human use; Approved or cleared medical devices
Stakeholders
7Guidance developed to assist sponsors in designing and conducting animal studies.
Performs histopathological assessment of biopsies
Provides a report summarizing key events for each animal enrolled in the study.
Entity responsible for submitting applications under section 524B
Board-certified professional recommended for necropsy
individual responsible for the overall conduct of a nonclinical laboratory study; Responsible for consulting with veterinarian and explaining outcomes; Individual responsible for the final study report and amendments; Responsible for reporting inspections and ensuring the report details the source of animals.
GLP Regulations also require the use of a Quality Assurance Unit (QAU)
Regulatory Context
Attributes
4A handling characteristic of a device.
Comparison of the device version used in the study to the final clinical version.
statistically justified calculation required in the plan
Use of Medical Device in Final Finished Form; Biocompatibility evaluation of the medical device; The condition of the medical device as it will be used
Identified Hazards
Hazards
2Data confounder making interpretation challenging
Observed findings that the pathologist must describe and interpret.
Related CFR Sections (11)
- 21CFR58.35§ 58.35 Quality assurance unit.
(a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quaRead full regulation →
- 21CFR3.8§ 3.8 Letter of designation.
(a) Each request for designation will be reviewed for completeness within 5 working days of receipt. Any request for designation determined to be incomplete will be returned to the applicant with a request for the missing information. The sponsor of an accepted request for designation will be notifiRead full regulation →
- 21CFR58.190§ 58.190 Storage and retrieval of records and data.
(a) All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study shall be retained.Read full regulation →
- 21CFR58.185§ 58.185 Reporting of nonclinical laboratory study results.
(a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to, the following:Read full regulation →
- 21CFR58.90§ 58.90 Animal care.
(a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals.Read full regulation →
- 21CFR58.43§ 58.43 Animal care facilities.
(a) A testing facility shall have a sufficient number of animal rooms or areas, as needed, to assure proper:Read full regulation →
- 21CFR58.15§ 58.15 Inspection of a testing facility.
(a) A testing facility shall permit an authorized employee of the Food and Drug Administration, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies withiRead full regulation →
- 21CFR58.107§ 58.107 Test and control article handling.
Procedures shall be established for a system for the handling of the test and control articles to ensure that:Read full regulation →
- 21CFR58.3§ 58.3 Definitions.
As used in this part, the following terms shall have the meanings specified:Read full regulation →
- 21CFR58.1§ 58.1 Scope.
(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additiveRead full regulation →
- 21CFR58.120§ 58.120 Protocol.
(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following information:Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
- 2025-05-20
CGMP/QSR/Medical Devices/Adulterated
NeuroSync, Inc.
- 2025-04-22
Noah Medical Corporation
See Also (8)
- Redbook 2000: IV.B.2 Guidelines for Reporting the Results of Toxicity Studies (Status: Final)
- CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission (Status: Final)
- Good Laboratory Practice Regulations Questions and Answers (Status: Final)
- Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Redbook 2000: IV.C.9.b. Guidelines for Developmental Toxicity Studies (Status: Final)
- Redbook 2000: IV.C.9.a.Guidelines for Reproduction Studies (Status: Final)
- Redbook 2000: IV.C.5.b. One-Year Toxicity Studies with Non-Rodents (Status: Final)