Table 1.

Selected FDA Federal Codes of Regulation Directly Relevant to Animal Studies Under Title 21

Title section	Topic
Good Laboratory practice for Nonclinical Laboratory Studies
58.1	Scope
58.3	Definitions
58.15	Inspection of a testing facility
58.29	Personnel
58.35	Quality assurance unit
58.43	Animal care facilities
58.47	Facilities for handling test and control articles
58.81	Standard operating procedures
58.90	Animal care
Investigational New Drugs
312.20	Requirement for an IND
312.23	IND content and format
312.32	IND safety reporting
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
807.92	Content and format of a 510(k) summary
Investigational Device Exemptions
812.1	Scope
812.3	Definitions
812.27	Report of prior investigations

Note.— Animal studies are also classified as “nonclinical” studies within some of these sections.