General considerations for animal studies intended to evaluate medical devices: guidance for industry and Food and Drug Administration staff

General considerations for animal studies intended to evaluate medical devices: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Contributor(s):
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 28, 2023
Language(s):
English
Format:
Text
Subject(s):
Animal Experimentation
Animal Welfare
Animals, Laboratory
Device Approval
Equipment Safety
Equipment and Supplies
Government Regulation
United States
Genre(s):
Guideline
Technical Report
Abstract:
FDA developed this guidance document to assist medical device sponsors, testing facilities, and other persons involved in designing, conducting, and reporting the results of animal studies intended to assess the safety of medical devices to support premarket submissions. These animal studies typically provide initial evidence of device safety, which may include device performance and handling, and the biological effects of the device when used in a living system. The recommendations in this guidance reflect current review practices and are intended to promote consistency and facilitate efficient review of medical device submissions that include animal study data. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (21 pages))
NLM Unique ID:
9918662283406676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918662283406676