Description
This guidance represents 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.
Scope & Applicability
Stakeholders
1The primary test subjects in developmental toxicity studies.
Regulatory Context
Attributes
1A characteristic required for selected animal strains.
Identified Hazards
Hazards
1One of the four major manifestations of an effect on the developing organism.
Related Warning Letters (9)
- 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.
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Sanitation & Environmental Technology Institute dba SDWH
- 2023-10-31
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Samm Solutions, Inc., d.b.a. BTS Research
- 2022-08-09
Bioresearch Monitoring Program
Valley Biosystems
- 2022-02-22
Good Laboratory Practice (GLP)
Toxikon Corporation/Labcorp Bedford LLC
- 2020-05-05
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
University of Kentucky
- 2020-04-07
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Steiner Biotechnology, LLC
See Also (8)
- Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- 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)
- Redbook 2000: IV.C.4.b. Subchronic Toxicity Studies with Non-Rodents (Status: Final)
- Redbook 2000: IV.C.4.a. Subchronic Toxicity Studies with Rodents (Status: Final)
- Redbook 2000: IV.C.3.b. Short-Term Toxicity Studies with Non-Rodents (Status: Final)
- Redbook 2000: IV.C.3.a. Short-Term Toxicity Studies with Rodents (Status: Final)
- Redbook 2000: IV.C.1.b. In vitro Mammalian Chromosomal Aberration Test (Status: Final)