# Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/criteria-for-significant-risk-investigations-of-magnetic-resonance-diagnostic-devices-guidance-for-industry-and-food-and-drug-administration-staff/9d5e44dc-a38c-4817-93c0-e7786f404f88

> FDA guidance document: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff. Issue date: June 19, 2014. Get complete insights and analysis.

---

## Details

- Title: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2014-06-19
- Last Changed: 2020-03-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-0957">FDA-2020-D-0957</a>

## Related Documents

- [Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices :  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/technical-performance-assessment-of-digital-pathology-whole-slide-imaging-devices-guidance-for-industry-and-food-and-drug-administration-staff/3dccc64f-9588-4e6e-a571-acd09e8f6108)
- [Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices:  Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/replacement-reagent-and-instrument-family-policy-for-in-vitro-diagnostic-devices-guidance-for-industry-and-fda-staff/6acf5cea-4730-4835-bf2d-eb7474c6d3e6)
- [Minimizing Risk for Children's Toy Laser Products:   Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/minimizing-risk-for-childrens-toy-laser-products-guidance-for-industry-and-food-and-drug-administration-staff/6373b533-1574-4697-a792-a773996abeed)
