News | Magnetic Resonance Imaging (MRI) | August 01, 2019 | Jeff Zagoudis, Associate Editor

FDA Issues Draft Guidance on Medical Device Safety in MRI Environment

Draft guidance document, available for public comment for 60 days, provides suggested standards for testing and labeling of medical devices meant to function in an MRI environment

FDA Issues Draft Guidance on Medical Device Safety in MRI Environment

August 1, 2019 — The U.S. Food and Drug Administration (FDA) issued a new draft guidance titled Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.

The MR environment presents unique safety hazards for patients and other persons with medical devices near or inside an MR system. This draft guidance, when finalized, is intended to:

  • Provide recommendations on testing for assessing the safety and compatibility of medical devices in the MR environment;
  • Identify test methods that address specific hazards and provide recommended format for MRI Safety Information in medical device labeling; and
  • Submit comments on the draft guidance.

According to the FDA, the guidance document “applies to all implanted medical devices, external medical devices that are fastened to or carried by a patient, and all medical devices that are intended to enter the MR environment.” Contents include recommendations on MR safety and compatibility assessments, as well as key information the agency says should be included in any FDA submissions for the affected devices. The guidance does not apply to the MRI scanner systems themselves. 

In the document, the FDA recommends that the safety and performance of a medical device should be assessed for all of the magnetic field strengths to which that device may potentially be exposed. Some of the potential safety issues covered in the document include: 

  • Magnetically induced displacement force and/or torque (unwanted movement of the device caused by the magnetic field); 
  • Heating of the medical device and/or surrounding tissue, by radiofrequency (RF) induction or switching magnetic field gradients;
  • Gradient induced vibration of the medical device;
  • Unintended stimulation of the device by switching gradient pulses;
  • Medical device malfunction; and
  • Image artifacts.

The FDA explains that all devices should be labeled as either MR-conditional (demonstrated safety in the MR environment within defined conditions), MR safe (poses no known hazards resulting from exposure to any MR environment) or MR unsafe (poses unacceptable risks to the patient,medical staff or other persons within the MR environment). 

This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2019-D-2837.

Read the full draft guidance document.

For more information: www.fda.gov

Related MRI Safety Content

Closing the Loopholes in MRI Safety

VIDEO: New App Improves MRI Safety For Implantable Devices

The Changing Relationship Between MRIs and Pacemakers

How To Manage Risk in the MR Suite

Related Content

Smoldering Spots in the Brain May Signal Severe MS

NIH researchers found that dark rimmed spots representing ongoing, “smoldering” inflammation, may be a hallmark of more disabling forms of multiple sclerosis. Image courtesy of Reich lab, NIH/NINDS.

News | Neuro Imaging | August 22, 2019
Aided by a high-powered brain scanner and a 3-D printer, National Institutes of Health (NIH) researchers peered inside...
Vaping Impairs Vascular Function

Image courtesy of the American Heart Association

News | Magnetic Resonance Imaging (MRI) | August 21, 2019
Inhaling a vaporized liquid solution through an e-cigarette, otherwise known as vaping, immediately impacts vascular...
Improved Imaging Technique Could Increase Chances of Prostate Cancer Survival
News | Prostate Cancer | August 20, 2019
According to the American Cancer Society, approximately one in nine men will be diagnosed with prostate cancer in their...
Some Pregnant Women Are Exposed to Gadolinium in Early Pregnancy
News | Women's Health | August 20, 2019
A small but concerning number of women are exposed to a commonly used magnetic resonance imaging (MRI) contrast agent...
New MRI Technique Captures Brain Changes in Near-real Time

Differences in stiffness between stimulus states. Image courtesy of Patz et al.

News | Neuro Imaging | August 19, 2019
An international team of researchers developed a new magnetic resonance imaging (MRI) technique that can capture an...
ADHD Medication May Affect Brain Development in Children

Images of regions of interest (colored lines) in the white matter skeleton representation. Data from left and right anterior thalamic radiation (ATR) were averaged. Image courtesy of C. Bouziane et al.

News | Neuro Imaging | August 16, 2019
A drug used to treat attention-deficit/hyperactivity disorder (ADHD) appears to affect development of the brain’s...
Profound Medical Receives U.S. FDA 510(k) Clearance for Tulsa-Pro
Technology | Interventional Radiology | August 16, 2019
Profound Medical Corp. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to...
Synaptive Medical Launches Modus Plan With Automated Tractography Segmentation
Technology | Neuro Imaging | August 07, 2019
Synaptive Medical announced the U.S. launch and availability of Modus Plan featuring BrightMatter AutoSeg. This release...
Canon Medical Introduces Encore Orian MR Upgrade Program
News | Magnetic Resonance Imaging (MRI) | August 06, 2019
Canon Medical Systems USA Inc. is helping to provide low-cost patient care solutions for its customers with the launch...