GUIDANCE DOCUMENT
Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff August 2020
- Docket Number:
- FDA-2019-D-1649
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
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for cutaneous electrodes for recording purposes will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
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All written comments should be identified with this document's docket number: FDA-2019-D-1649.