Cutaneous electrodes for recording purposes--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Cutaneous electrodes for recording purposes--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020
Language(s):
English
Format:
Text
Subject(s):
Electrodes
Equipment Design
Equipment Safety
Electrocardiography
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance provides performance criteria for cutaneous electrodes in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for cutaneous electrodes for recording purposes will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (8 pages)).
NLM Unique ID:
9918227356306676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227356306676