Regulatory News

FDA to Replace 17-Year-Old Guidance for MRI Premarket Notifications

The US Food and Drug Administration (FDA) is seeking input as it begins to draft a new guidance intended to help makers of magnetic resonance diagnostic devices (MRDDs) complete premarket notification 510(k) applications.

Background

After scientific advances in the 1970s led to the first images produced using magnetic resonance (MR), clinical interest in the technology grew rapidly. In the 1980s, these advances made magnetic resonance imaging (MRI) useful for clinical applications, especially for cardiac imaging.

Now MR technology is commonly used for imaging many parts of the body, including the head and brain, blood vessels, abdomen, pelvic region and spine.

As a new technology, MRDDs were considered to be Class III devices, which required premarket approval (PMA) and the completion of a premarket notification 510(k) before they could be marketed.

However, by 1988, FDA felt sufficient evidence had been gathered demonstrating the safety of MRDDs, and reclassified them to the lower-risk Class II.

Unlike other imaging techniques such as X-rays or CT scans, MRDDs do not emit harmful radiation. However, there are still risks due to the strong magnetic field generated by these devices. As such, MRDDs should not be used with certain implantable medical devices.

New Guidance

FDA's current Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices was introduced in 1998.

Since then, there have been numerous technological and scientific developments that have improved MR technology, including the advent of magnetic resonance spectroscopy and functional MRI (fMRI).

FDA says the new guidance will help clarify the formatting and information the agency expects for 510(k) premarket notification for MRDDs. The new guidance will also apply to "new magnetic resonance imaging (MRI) and magnetic resonance spectroscopy systems, new components, and modifications to systems and components that have a significant impact on safety or effectiveness of the [MRDD]."

FDA is asking interested parties to submit their comments on the draft guidance before 13 October 2015 to be considered before the agency begins work on the final guidance.

Federal Register, Draft Guidance