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GUIDANCE DOCUMENT

General Considerations for Animal Studies for Medical Devices Guidance for Industry and Food and Drug Administration Staff October 2015

Draft

Not for implementation. Contains non-binding recommendations.

General Considerations for Animal Studies for Medical Devices

Docket Number:
FDA-2015-D-3419
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The animal studies utilized for the assessment of these devices typically provide initial evidence of device safety, their potential performance when used in a living system, and the biologic response that a living system may mount towards the device. This guidance provides recommendations for members of industry who perform, and FDA staff who review evaluations of, animal studies for medical devices. In this document, the terms "you" and "your" refer to members of industry, also known 119 as "sponsors" or "applicants." The terms "we," "us," "our," and "Agency" refer to FDA.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-3419.