Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

Issue Date: August 14, 2020
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Neurological
Status: Final

Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

This final 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for cutaneous electrodes for recording purposes will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

Download the Guidance Document