Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
Published: 2014-06-19
Status: Final Type: Guidance Document Category: Premarket (510(k) / PMA / De Novo / IDE) Topics: Premarket Docket: FDA-2020-D-0957
Official Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/criteria-significant-risk-investigations-magnetic-resonance-diagnostic-devices-guidance-industry-and PDF: https://www.fda.gov/media/71385/download
Official Full Text
Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. Studies of Magnetic Resonance Diagnostic Devices If a clinical study is needed to demonstrate substantial equivalence, i.e., conducted prior to obtaining 510(k) clearance of the device, the study must be conducted under the IDE regulation (21 CFR Part 812). FDA believes that a magnetic resonance diagnostic device used under any one of the operating conditions listed below is a significant risk device as defined in 21 CFR 812.3(m)(4) and, therefore, that studies involving such a device do not qualify for the abbreviated IDE requirements of 21 CFR 812.2(b). In addition to the requirement of having an FDA-approved IDE, sponsors of significant risk studies must comply with the regulations governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50). Significant Risk Magnetic Resonance Diagnostic Devices You should consider the following operating conditions when assessing whether a study may be considered significant risk: • main static magnetic field • specific absorption rate (SAR) • gradient fields rate of change • sound pressure level Generally, FDA deems magnetic resonance diagnostic devices significant risk when used under any of the operating conditions described below.
Main Static Magnetic Field Population Main static magnetic field greater than (tesla) adults, children, and infants aged > 1 month neonates i.e., infants aged 1 month or less 3
Specific Absorption Rate (SAR) Site Dose Time (min) equal to or greater than: SAR (W/kg) whole body averaged over >4 head averaged over >3.2
If you have questions about significant risk criteria related to local SAR, you may wish to contact FDA.
Gradient Fields Rate of Change Any time rate of change of gradient fields (dB/dt) sufficient to produce severe discomfort or painful nerve stimulation
Sound Pressure Level Peak unweighted sound pressure level greater than 140 dB.
A-weighted root mean square (rms) sound pressure level greater than 99 dBA with hearing protection in place.
These criteria apply only to device operating conditions. Other aspects of the study may involve significant risks and the study, therefore, may require IDE approval regardless of operating conditions. See Blue Book Memorandum entitled Significant Risk and Nonsignificant Risk Medical Device Studies (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126418.pdf) for further discussion.
After FDA determines that the device is substantially equivalent, clinical studies conducted in accordance with the indications reviewed in the 510(k), including clinical design validation studies conducted in accordance with the quality systems regulation, are exempt from the investigational device exemptions (IDE) requirements. However, such studies must be performed in conformance with 21 CFR 56 and 21 CFR 50.