> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Magnetic Resonance Coil Performance Criteria Guide
- URL: https://www.fdaweb.com/magnetic-resonance-coil-performance-criteria-guide/
- Published: 2019-12-06T12:00:00.000Z
- Updated: 2026-09-14T15:55:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145672

FDA has posted a [draft guidance](https://www.fda.gov/media/133250/download?ref=fdaweb.com) on “Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for MR coils to use for clearance under the agency’s [Safety and Performance Based Pathway](https://www.fda.gov/medical-devices/premarket-notification-510k/framework-safety-and-performance-based-pathway?ref=fdaweb.com). Under the framework, submitters planning to submit a 510(k) using the pathway for such devices will have the option to use the performance criteria proposed in guidance to support substantial equivalence instead of a direct comparison of the performance of the subject device to that of a predicate device. The MR coils that are the subject of this guidance are intended to produce images of human anatomy for general diagnostic use by trained clinicians. The coils are Class2 devices regulated under 21 CFR 892.1000 (magnetic resonance diagnostic device) with the product code 87MOS(Coil, Magnetic Resonance, Specialty).